- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01753557
Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C
August 9, 2016 updated by: Mitsubishi Tanabe Pharma Corporation
A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Takatsu-ku
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Kawasaki City, Takatsu-ku, Japan, 213-8587
- Toranomon Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment-Naive
|
MP-424: 750mg every 8 hours (q8h) for 12 weeks
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
|
Experimental: Treatment-Relapsed
|
MP-424: 750mg every 8 hours (q8h) for 12 weeks
RBV: 600 - 1000 mg/day based on body weight for 24 weeks
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)
Time Frame: 4 weeks
|
4 weeks
|
Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)
Time Frame: 24 weeks
|
24 weeks
|
Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration
Time Frame: 36 weeks
|
36 weeks
|
Transition of Serum HCV RNA Levels
Time Frame: baseline,Day2,Day3,1Weeks,2Weeks,3Weeks,4Weeks,End of treatment,Follow-up 12weeks,Follow-up 24weeks
|
baseline,Day2,Day3,1Weeks,2Weeks,3Weeks,4Weeks,End of treatment,Follow-up 12weeks,Follow-up 24weeks
|
Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus(Result of Resistance-associated Variants Analysis)
Time Frame: From baseline to 24 weeks after completion of drug administration
|
From baseline to 24 weeks after completion of drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kazuoki Kondo, M.D., Mitsubishi Tanabe Pharma Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
December 13, 2012
First Submitted That Met QC Criteria
December 17, 2012
First Posted (Estimate)
December 20, 2012
Study Record Updates
Last Update Posted (Estimate)
October 3, 2016
Last Update Submitted That Met QC Criteria
August 9, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- G060-A12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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