Phase 3
Completed N=74
Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)
Chronic Hepatitis C(CHC)
Source: ClinicalTrials.gov NCT01753570 ↗
Enrolled (actual)
74
Serious AEs
16.2%
Results posted
Oct 2018
Primary outcomePrimary: Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) — 63.3; 20.0; 71.4 percentage of subjects achieving SVR
◆ Published Evidence
Emerging
1citation · ~0 / year
Efficacy and safety of telaprevir with natural human interferon-β and ribavirin in Japanese chronic hepatitis C patients with depression.
Summary
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.
Linked Publications
-
Efficacy and safety of telaprevir with natural human interferon-β and ribavirin in Japanese chronic hepatitis C patients with depression.
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) |
63.3; 20.0; 71.4 | — |
| SECONDARY Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) |
70.0; 6.7; 92.9 | — |
| SECONDARY Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) |
76.7; 30.0; 85.7 | — |
| SECONDARY Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration |
66.7; 20.0; 71.4 | — |
| SECONDARY Transition of Serum HCV RNA Levels |
6.73; 6.83; 6.05; 4.15; 5.65; 3.80 | — |
| SECONDARY Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV. |
1; 0; 1; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
- Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based 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 serious 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 (NCT01753570) 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.