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A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00922779
Enrollment
6661
Registered
2009-06-17
Start date
2002-06-30
Completion date
2012-06-30
Last updated
2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Brief summary

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Interventions

DRUGpeginterferon alfa-2a [Pegasys]

180micrograms sc weekly for 12-48 weeks

DRUGribavirin

800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult patients, \>=18 years of age; * serological evidence of chronic hepatitis C; * detectable serum HCV-RNA; * liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion criteria

* history or other evidence of a medical condition associated with chronic liver disease other than HCV; * co-infection with active hepatitis A or B; * hepatocellular carcinoma; * patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)From signing of informed consent up to end of study (up to Week 72)An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

Secondary

MeasureTime frameDescription
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy24 weeks after end of therapy (Week 72)SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.
Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy InitiationWeeks 12,24 and 48 After Therapy InitiationHCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48.
Percentage of Participants With Change in Hemoglobin LevelBaseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)Change in hemoglobin level (compared to baseline) was reported as significant decrease, Normal (no change), Increase, Decrease, and Missing. Significant decrease was defined as per Investigator's discretion.

Countries

Russia

Participant flow

Recruitment details

A total of 7799 participants were screened, of which 6661 participants were included in the study.

Participants by arm

ArmCount
Ribavirin + Peginterferon Alfa-2a
Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
6,661
Total6,661

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event67
Overall StudyLost to Follow-up44
Overall StudyMissing1,874
Overall StudyOther27
Overall StudyPregnancy7
Overall StudyWithdrawal by Subject308

Baseline characteristics

CharacteristicRibavirin + Peginterferon Alfa-2a
Age, Continuous34.21 Years
STANDARD_DEVIATION 9.81
Sex/Gender, Customized
Female
2250 Participants
Sex/Gender, Customized
Male
4396 Participants
Sex/Gender, Customized
Missing
15 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
1,674 / 6,661
serious
Total, serious adverse events
67 / 6,661

Outcome results

Primary

Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

Time frame: From signing of informed consent up to end of study (up to Week 72)

Population: Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.

ArmMeasureGroupValue (NUMBER)
Ribavirin + Peginterferon Alfa-2aNumber of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)Non Serious AEs2058 Participants
Ribavirin + Peginterferon Alfa-2aNumber of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)SAEs67 Participants
Secondary

Percentage of Participants With Change in Hemoglobin Level

Change in hemoglobin level (compared to baseline) was reported as significant decrease, Normal (no change), Increase, Decrease, and Missing. Significant decrease was defined as per Investigator's discretion.

Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

Population: ITT Population.

ArmMeasureGroupValue (NUMBER)
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 2, Significant decrease13.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 2, Normal32.4 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 2, Increase11.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 2, Decrease32.3 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 2, Missing10.0 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 4, Significant decrease27.9 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 4, Normal21.0 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 4, Increase6.9 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 4, Decrease35.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 4, Missing9.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 8, Significant decrease35.4 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 8, Normal15.3 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 8, Increase5.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 8, Decrease31.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 8, Missing12.8 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 12, Significant decrease38.9 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 12, Normal15.2 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 12, Increase4.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 12, Decrease30.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 12, Missing11.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 24, Significant decrease34.9 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 24, Normal13.6 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 24, Increase4.6 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 24, Decrease25.4 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 24, Missing21.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 36, Significant decrease16.2 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 36, Normal4.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 36, Increase1.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 36, Decrease9.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 36, Missing69.0 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 48, Significant decrease13.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 48, Normal3.8 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 48, Increase1.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 48, Decrease7.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelWeek 48, Missing73.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 4, Significant decrease11.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 4, Normal18.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 4, Increase6.8 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 4, Decrease19.6 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 4, Missing43.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 12, Significant decrease5.8 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 12, Normal23.0 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 12, Increase10.2 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 12, Decrease16.1 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 12, Missing44.8 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 24, Significant decrease4.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 24, Normal27.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 24, Increase12.2 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 24, Decrease15.5 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Change in Hemoglobin LevelFollow-up Week 24, Missing40.2 Percentage of Participants
Secondary

Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy

SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.

Time frame: 24 weeks after end of therapy (Week 72)

Population: Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.

ArmMeasureValue (NUMBER)
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy50.9 Percentage of Participants
Secondary

Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation

HCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48.

Time frame: Weeks 12,24 and 48 After Therapy Initiation

Population: ITT Population.

ArmMeasureGroupValue (NUMBER)
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy InitiationWeek 1258.8 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy InitiationWeek 2469.7 Percentage of Participants
Ribavirin + Peginterferon Alfa-2aPercentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy InitiationWeek 4824.8 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026