Hepatitis C
Conditions
Keywords
Chronic Hepatitis C, Protease Inhibitor, Telaprevir, Peginterferon Alfa-2b, Ribavirin
Brief summary
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
Interventions
DRUGMP-424
750 mg every 8 hours for 12 weeks
DRUGRibavirin
600 - 1000 mg/day based on body weight for 24 weeks
DRUGPeginterferon Alfa-2b
1.5 mcg/kg/week for 24 weeks
Sponsors
Vertex Pharmaceuticals Incorporated
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Genotype 1, chronic hepatitis C * Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C) * Able and willing to follow contraception requirements
Exclusion criteria
* Cirrhosis of the liver or hepatic failure * Hepatitis B surface antigen-positive or HIV 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 |
|---|---|
| The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | After 24 weeks of follow-up |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TRV/PEG/RBV Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks | 126 |
| PEG/RBV Drug: Ribavirin 600 - 1000 mg/day based on body weight for 48 weeks
Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 48 weeks | 63 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 3 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 6 |
Baseline characteristics
| Characteristic | TRV/PEG/RBV | PEG/RBV | Total |
|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 10.4 | 52.2 years STANDARD_DEVIATION 9.7 | 51.3 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 60 Participants | 30 Participants | 90 Participants |
| Sex: Female, Male Male | 66 Participants | 33 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 126 / 126 | 63 / 63 |
| serious Total, serious adverse events | 15 / 126 | 6 / 63 |
Outcome results
Primary
The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time frame: After 24 weeks of follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TRV/PEG/RBV | The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 73.0 percentage of subjects achieving SVR |
| PEG/RBV | The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 49.2 percentage of subjects achieving SVR |