Phase 3
Completed N=189
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00780416 ↗Enrolled (actual)
189
Serious AEs
11.1%
Results posted
Aug 2012
Primary outcomePrimary: 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; 49.2 percentage of subjects achieving SVR
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
73.0; 49.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00780416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.