Hepatitis C, Chronic
Conditions
Brief summary
This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.
Interventions
DRUGBoceprevir (BOC)
200 mg capsules, 800 mg three times daily by mouth
200 mg placebo capsules, 800 mg three times daily by mouth
1.5 mcg/kg/week subcutaneously
DRUGRibavirin (RBV)
200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
DRUGCross-Over Boceprevir Treatment
At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible. * Liver biopsy with histology consistent with CHC and no other etiology. * Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma * Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV * Weight between 40 kg and 125 kg, inclusive * Of 'local' ancestral descent * Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception
Exclusion criteria
* Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus. * Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon. * Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening. * Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity. * Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit. * Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. * Diabetes and/or hypertension with clinically significant ocular examination findings. * Any condition the could interfere with participation in and completion of the trial. * Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin). * Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population | Follow-up Week 24 | SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. |
| Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population | Follow-up Week 24 | SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8 | Treatment Week 8 | Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8) |
| Percentage of Participants in India Achieving EVR at Treatment Week 8 | Treatment Week 8 | Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8) |
| Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Up to 96 weeks | Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters). |
| Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population | Follow-up Week 24 | SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. |
| Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Up to 96 weeks | Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant. |
| Percentage of Participants With an AE of Neutropenia in India | Up to 96 weeks | Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant. |
| Percentage of Participants With an AE of Anemia in India | Up to 96 weeks | Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters). |
| Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population | Follow-up Week 24 | SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR. |
Participant flow
Recruitment details
Adult participants in an Asia Pacific population with chronic Hepatitis C (CHC) genotype 1 who have failed prior treatment with pegylated interferon and ribavirin (PR) were selected to participate in this study.
Pre-assignment details
Of 282 participants randomized and treated, 269 participants followed Good Clinical Practice (GCP); 13 participants did not follow GCP.
Participants by arm
| Arm | Count |
|---|---|
| Boceprevir - Korea+Taiwan PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up. | 133 |
| Control - Korea+Taiwan PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14. | 65 |
| Boceprevir - India PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up. | 57 |
| Control - India PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14. | 27 |
| Total | 282 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Follow-Up Phase | Non-Medical Reasons | 1 | 1 | 1 | 0 |
| Treatment Phase | Adverse Event | 12 | 2 | 3 | 2 |
| Treatment Phase | Non-GCP Compliant | 0 | 0 | 10 | 3 |
| Treatment Phase | Non-Medical Reasons | 5 | 1 | 8 | 1 |
| Treatment Phase | Treatment Failure | 23 | 25 | 10 | 13 |
Baseline characteristics
| Characteristic | Boceprevir - Korea+Taiwan | Control - Korea+Taiwan | Boceprevir - India | Control - India | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.0 Years STANDARD_DEVIATION 10.15 | 52.4 Years STANDARD_DEVIATION 9.8 | 47.9 Years STANDARD_DEVIATION 9.83 | 45.2 Years STANDARD_DEVIATION 12.27 | 51.6 Years STANDARD_DEVIATION 10.63 |
| Sex: Female, Male Female | 48 Participants | 28 Participants | 18 Participants | 5 Participants | 99 Participants |
| Sex: Female, Male Male | 85 Participants | 37 Participants | 39 Participants | 22 Participants | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 131 / 133 | 62 / 65 | 44 / 47 | 15 / 24 |
| serious Total, serious adverse events | 16 / 133 | 3 / 65 | 0 / 47 | 2 / 24 |
Outcome results
Primary
Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Time frame: Follow-up Week 24
Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population | 53.19 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population | 20.83 Percentage of Participants |
Comparison: Between-Group Comparisonp-value: 0.006395% CI: [10.15, 52.18]Miettinen and Numinen
Primary
Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population
SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Time frame: Follow-up Week 24
Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population | 60.90 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population | 26.15 Percentage of Participants |
Comparison: Between-Group Comparisonp-value: <0.000195% CI: [20.24, 47.18]Miettinen and Numinen
Secondary
Percentage of Participants in India Achieving EVR at Treatment Week 8
Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)
Time frame: Treatment Week 8
Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants in India Achieving EVR at Treatment Week 8 | 59.57 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants in India Achieving EVR at Treatment Week 8 | 25.00 Percentage of Participants |
Comparison: Between-Group Comparisonp-value: 0.00495% CI: [12.12, 55.01]Mittienen and Nurminen
Secondary
Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Time frame: Follow-up Week 24
Population: mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm); participants who did not demonstrate GCP compliance were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population | 53.19 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population | 21.74 Percentage of Participants |
Comparison: Between-Group Comparisonp-value: 0.008695% CI: [8.96, 51.83]Miettinen and Numinen
Secondary
Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8
Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)
Time frame: Treatment Week 8
Population: FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8 | 73.68 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8 | 44.62 Percentage of Participants |
Comparison: Between-Group Comparisonp-value: <0.00195% CI: [15.26, 42.22]Miettinen and Nurminen
Secondary
Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population
SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.
Time frame: Follow-up Week 24
Population: mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population | 61.83 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population | 26.56 Percentage of Participants |
Comparison: Between-Group Comparisonp-value: <0.000195% CI: [20.51, 47.72]Miettinen and Numinen
Secondary
Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan
Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).
Time frame: Up to 96 weeks
Population: All Participants as Treated (APaT) - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 2 (8.0 to <9.5 g/dL of hemoglobin) | 29.3 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 3 (6.5 to <8.0 g/dL of hemoglobin) | 4.5 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 1 (9.5 to <11 g/dL of hemoglobin) | 34.6 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 4 (<6.5 g/dL of hemoglobin) | 0.0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 4 (<6.5 g/dL of hemoglobin) | 0.0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 2 (8.0 to <9.5 g/dL of hemoglobin) | 7.7 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 1 (9.5 to <11 g/dL of hemoglobin) | 43.1 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan | Grade 3 (6.5 to <8.0 g/dL of hemoglobin) | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With an AE of Anemia in India
Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).
Time frame: Up to 96 weeks
Population: APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 1 (9.5 to <11 g/dL of hemoglobin) | 25.5 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 2 (8.0 to <9.5 g/dL of hemoglobin) | 46.8 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 3 (6.5 to <8.0 g/dL of hemoglobin) | 10.6 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 4 (<6.5 g/dL of hemoglobin) | 0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 4 (<6.5 g/dL of hemoglobin) | 0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 1 (9.5 to <11 g/dL of hemoglobin) | 33.3 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 3 (6.5 to <8.0 g/dL of hemoglobin) | 0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Anemia in India | Grade 2 (8.0 to <9.5 g/dL of hemoglobin) | 8.3 Percentage of Participants |
Secondary
Percentage of Participants With an AE of Neutropenia in India
Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.
Time frame: Up to 96 weeks
Population: APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 1 (1.0 to 1.5x10^9/L of neutrophils) | 51.1 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 3 (0.5 to <0.75x10^9/L of neutrophils) | 6.4 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 4 (<0.5x10^9/L of neutrophils) | 2.1 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 2 (0.75 to <1.0x10^9/L of neutrophils) | 12.8 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 4 (<0.5x10^9/L of neutrophils) | 0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 1 (1.0 to 1.5x10^9/L of neutrophils) | 29.2 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 2 (0.75 to <1.0x10^9/L of neutrophils) | 4.2 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in India | Grade 3 (0.5 to <0.75x10^9/L of neutrophils) | 0 Percentage of Participants |
Secondary
Percentage of Participants With an AE of Neutropenia in Korea and Taiwan
Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.
Time frame: Up to 96 weeks
Population: APaT - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 1 (1.0 to 1.5x10^9/L of neutrophils) | 30.1 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 2 (0.75 to <1.0x10^9/L of neutrophils) | 24.8 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 3 (0.5 to <0.75x10^9/L of neutrophils) | 22.6 Percentage of Participants |
| Boceprevir - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 4 (<0.5x10^9/L of neutrophils) | 3.8 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 4 (<0.5x10^9/L of neutrophils) | 0.0 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 1 (1.0 to 1.5x10^9/L of neutrophils) | 41.5 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 3 (0.5 to <0.75x10^9/L of neutrophils) | 12.3 Percentage of Participants |
| Control - Korea+Taiwan | Percentage of Participants With an AE of Neutropenia in Korea and Taiwan | Grade 2 (0.75 to <1.0x10^9/L of neutrophils) | 20.0 Percentage of Participants |