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)
This study is currently recruiting participants.
Verified December 2012 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Collaborator:
Toray Industries, Inc
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01753570
First received: December 13, 2012
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C(CHC) |
Drug: MP-424 Drug: RBV Drug: IFN beta |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mitsubishi Tanabe Pharma Corporation:
Primary Outcome Measures:
- Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 weeks after completion of drug administration (SVR, sustained viral response) [ Time Frame: 72 weeks(Genotype 1 groups), 48 weeks(Genotype 2 group) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Undetectable HCV RNA at 4 weeks after beginning of drug administration (RVR, rapid viral response) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Undetectable HCV RNA at completion of drug administration (ETR, end-of-treatment response) [ Time Frame: 24 weeks(Genotype 1 groups), 24 weeks(Genotype 2 group) ] [ Designated as safety issue: No ]
- Undetectable HCV RNA at 12 weeks after completion of drug administration [ Time Frame: 60 weeks(Genotype 1 groups), 36 weeks(Genotype 2 group) ] [ Designated as safety issue: No ]
- Transition of serum HCV RNA levels [ Time Frame: From baseline to 24 weeks after completion of drug administration ] [ Designated as safety issue: No ]
- Viral sequencing at the NS-3 protease region of HCV virus [ Time Frame: From baseline to 24 weeks after completion of drug administration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MP-424(+RBV+IFN), Genotype1 |
Drug: MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
Drug: RBV
RBV: 600 - 1000 mg/day based on body weight for 48 weeks
Drug: IFN beta
IFN: 600 MIU/day, 6 days/week for initial 4 weeks following to 3 days/week
|
| Experimental: RBV+IFN, Genotype1 |
Drug: RBV
RBV: 600 - 1000 mg/day based on body weight for 48 weeks
Drug: IFN beta
IFN: 600 MIU/day, 6 days/week for initial 4 weeks following to 3 days/week
|
| Experimental: MP-424(+RBV+IFN), Genotype2 |
Drug: MP-424
MP-424: 750mg every 8 hours (q8h) for 12 weeks
Drug: RBV
RBV: 600 - 1000 mg/day based on body weight for 48 weeks
Drug: IFN beta
IFN: 600 MIU/day, 6 days/week for initial 4 weeks following to 3 days/week
|
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Genotype 1 or 2, chronic hepatitis C, with depression(including the past)
- treatment-naïve or patient who have ever had 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 serious depression, schizophrenia,; or suicide attempt in the past
- Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753570
Contacts
| Contact: Clinical Trials Information Desk | cti-inq-ml@ml.mt-pharma.co.jp |
Locations
| Japan | |
| Toranomon Hospital | Recruiting |
| Kawasaki City, Takatsu-ku, Japan, 213-8587 | |
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Toray Industries, Inc
Investigators
| Study Director: | Kazuoki Kondo, M.D. | Mitsubishi Tanabe Pharma Corporation |
More Information
No publications provided
| Responsible Party: | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier: | NCT01753570 History of Changes |
| Other Study ID Numbers: | G060-F1 |
| Study First Received: | December 13, 2012 |
| Last Updated: | December 20, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
|
Feron |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Interferon-beta Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013