Chronic Hepatitis C(CHC) Clinical Trial
Official title:
A Phase 3 Study of MP-424 in Combination With IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy
| NCT number | NCT01753570 |
| Other study ID # | G060-F1 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | December 2012 |
| Est. completion date | October 2015 |
| Verified date | January 2018 |
| Source | Mitsubishi Tanabe Pharma Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Toranomon Hospital | Kawasaki City | Takatsu-ku |
| Lead Sponsor | Collaborator |
|---|---|
| Mitsubishi Tanabe Pharma Corporation | Toray Industries, Inc |
Japan,
Kumada H, Mochida S, Nakamuta M, Suzuki F, Yagi T, Takasaki R, Okai M, Kamiya N, Okada Y, Hirota S, Orihashi M, Ochi M, Chayama K. Efficacy and safety of telaprevir with natural human interferon-ß and ribavirin in Japanese chronic hepatitis C patients wit — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) | 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta) | ||
| Secondary | Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) | 4 weeks | ||
| Secondary | Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) | 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta) | ||
| Secondary | Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration | 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta) | ||
| Secondary | Transition of Serum HCV RNA Levels | Baseline,Day2,Day3,1Week,2Weeks,3Weeks,4Weeks,12Weeks,End of treatment,Follow-up 12weeks,Follow-up 24weeks | ||
| Secondary | Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV. | To examine the emergence of resistance-associated variants after MP-424 administration. | From baseline to 24 weeks after completion of drug administration |