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Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753557
First Posted: December 20, 2012
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C (CHC) Drug: MP-424 Drug: RBV Drug: PEG-IFN alfa-2a Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

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: 48 weeks ]

Secondary Outcome Measures:
  • Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) [ Time Frame: 4 weeks ]
  • Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) [ Time Frame: 24 weeks ]
  • Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration [ Time Frame: 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 ]
  • 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 ]

Enrollment: 54
Study Start Date: December 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment-Naive 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 24 weeks
Drug: PEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks
Experimental: Treatment-Relapsed 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 24 weeks
Drug: PEG-IFN alfa-2a
PEG-IFN alfa-2a: 180mcg/week for 24 weeks

  Eligibility

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753557


Locations
Japan
Toranomon Hospital
Kawasaki City, Takatsu-ku, Japan, 213-8587
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Kazuoki Kondo, M.D. Mitsubishi Tanabe Pharma Corporation
  More Information

Publications:
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01753557     History of Changes
Other Study ID Numbers: G060-A12
First Submitted: December 13, 2012
First Posted: December 20, 2012
Results First Submitted: June 14, 2016
Results First Posted: October 3, 2016
Last Update Posted: October 3, 2016
Last Verified: August 2016

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Pegasys

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs