Chronic Hepatitis C (CHC)
Conditions
Keywords
Pegasys
Brief summary
This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.
Interventions
DRUGMP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
DRUGRBV
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
DRUGPEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Genotype 1 CHC * treatment-naïve or relapsers (patient who relapsed after previous treatment) * Able and willing to follow contraception requirements
Exclusion criteria
* Cirrhosis of the liver or hepatic failure * Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive * History of, or concurrent hepatocellular carcinoma * History of, or concurrent depression, schizophrenia, or suicide attempt in the past * Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) | 4 weeks |
| Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) | 24 weeks |
| Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration | 36 weeks |
| Transition of Serum HCV RNA Levels | baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks |
| Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | From baseline to 24 weeks after completion of drug administration |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment-Naive Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks | 35 |
| Treatment-Relapsed Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks | 19 |
| Total | 54 |
Baseline characteristics
| Characteristic | Treatment-Naive | Treatment-Relapsed | Total |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 10.5 | 54.3 years STANDARD_DEVIATION 9.5 | 52.6 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 26 Participants | 10 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 35 | 19 / 19 |
| serious Total, serious adverse events | 0 / 35 | 2 / 19 |
Outcome results
Primary
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time frame: 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive | Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 85.7 percentage of subjects achieving SVR |
| Treatment-Relapsed | Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 94.7 percentage of subjects achieving SVR |
Secondary
Transition of Serum HCV RNA Levels
Time frame: baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment-Naive | Transition of Serum HCV RNA Levels | 1Weeks (n=35,19) | 2.00 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | Follow-up 12Weeks (n=33,19) | 0.50 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | 2Weeks (n=34,19) | 1.00 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | Day2 (n=35,19) | 3.80 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | 3Weeks (n=35,19) | 0.50 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | Follow-up 24Weeks (n=35,19) | 0.50 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | 4Weeks (n=35,19) | 0.50 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | Day3 (n=35,19) | 3.10 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | End of treatment (n=35,19) | 0.50 log IU/mL |
| Treatment-Naive | Transition of Serum HCV RNA Levels | baseline (n=35,19) | 6.70 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | Follow-up 24Weeks (n=35,19) | 0.50 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | Follow-up 12Weeks (n=33,19) | 0.50 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | baseline (n=35,19) | 7.05 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | Day2 (n=35,19) | 4.00 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | Day3 (n=35,19) | 3.30 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | 1Weeks (n=35,19) | 2.00 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | 2Weeks (n=34,19) | 1.00 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | 3Weeks (n=35,19) | 0.50 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | 4Weeks (n=35,19) | 0.50 log IU/mL |
| Treatment-Relapsed | Transition of Serum HCV RNA Levels | End of treatment (n=35,19) | 0.50 log IU/mL |
Secondary
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Time frame: 36 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive | Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration | 82.9 percentage of subjects achieving SVR12 |
| Treatment-Relapsed | Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration | 94.7 percentage of subjects achieving SVR12 |
Secondary
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive | Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) | 88.6 percentage of subjects achieving RVR |
| Treatment-Relapsed | Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) | 100.0 percentage of subjects achieving RVR |
Secondary
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive | Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) | 97.1 percentage of subjects achieving ETR |
| Treatment-Relapsed | Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) | 100.0 percentage of subjects achieving ETR |
Secondary
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)
Time frame: From baseline to 24 weeks after completion of drug administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-Naive | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | V36A | 1 participants |
| Treatment-Naive | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | T54A | 0 participants |
| Treatment-Naive | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | Not detected | 3 participants |
| Treatment-Relapsed | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | V36A | 0 participants |
| Treatment-Relapsed | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | T54A | 1 participants |
| Treatment-Relapsed | Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) | Not detected | 0 participants |