Phase 3
Completed N=32
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy
Source: ClinicalTrials.gov NCT00781274 ↗Enrolled (actual)
32
Serious AEs
9.4%
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) — 34.4 percentage of subjects achieving SVR
Summary
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.
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) |
34.4 | — |
Eligibility Criteria
Inclusion Criteria
- Genotype 1, chronic hepatitis C
- Non-responders (patient who did not respond to 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 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 (NCT00781274). 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.