Phase 3
Completed N=54
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
Chronic Hepatitis C (CHC)
Source: ClinicalTrials.gov NCT01753557 ↗
Enrolled (actual)
54
Serious AEs
3.7%
Results posted
Oct 2016
Primary outcomePrimary: Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) — 85.7; 94.7 percentage of subjects achieving SVR
◆ Published Evidence
Emerging
5citations · ~1 / year
Efficacy and safety of telaprevir with pegylated interferon α-2a and ribavirin in Japanese patients.
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.
Linked Publications
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Efficacy and safety of telaprevir with pegylated interferon α-2a and ribavirin in Japanese patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) |
85.7; 94.7 | — |
| SECONDARY Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) |
88.6; 100.0 | — |
| SECONDARY Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) |
97.1; 100.0 | — |
| SECONDARY Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration |
82.9; 94.7 | — |
| SECONDARY Transition of Serum HCV RNA Levels |
6.70; 7.05; 3.80; 4.00; 3.10; 3.30 | — |
| SECONDARY Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) |
1; 0; 0; 1; 3; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01753557) and the linked publication. 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.