NCT01753557

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 3, 2016

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 13, 2012

Results QC Date

June 14, 2016

Last Update Submit

December 15, 2025

Conditions

Chronic Hepatitis C (CHC)

Keywords

Pegasys

Outcome Measures

Primary Outcomes (1)

  • Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

    48 weeks

Secondary Outcomes (5)

  • Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)

    4 weeks

  • Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)

    24 weeks

  • Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration

    36 weeks

  • Transition of Serum HCV RNA Levels

    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)

    From baseline to 24 weeks after completion of drug administration

Study Arms (2)

Treatment-Naive

EXPERIMENTAL
Drug: MP-424Drug: RBVDrug: PEG-IFN alfa-2a

Treatment-Relapsed

EXPERIMENTAL
Drug: MP-424Drug: RBVDrug: PEG-IFN alfa-2a

Interventions

MP-424DRUG

MP-424: 750mg every 8 hours (q8h) for 12 weeks

Treatment-NaiveTreatment-Relapsed
RBVDRUG

RBV: 600 - 1000 mg/day based on body weight for 24 weeks

Treatment-NaiveTreatment-Relapsed
PEG-IFN alfa-2aDRUG

PEG-IFN alfa-2a: 180mcg/week for 24 weeks

Treatment-NaiveTreatment-Relapsed

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Genotype 1 CHC
  • treatment-naïve or relapsers (patient who relapsed after previous treatment)
  • Able and willing to follow contraception requirements

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toranomon Hospital

Kawasaki, Takatsu-ku, 213-8587, Japan

Location

Related Publications (1)

  • Kumada H, Suzuki F, Kamiya N, Orihashi M, Nakayasu Y, Yamada I. Efficacy and safety of telaprevir with pegylated interferon alpha-2a and ribavirin in Japanese patients. Hepatol Res. 2017 May;47(6):514-521. doi: 10.1111/hepr.12722. Epub 2016 Jun 4.

    PMID: 27062488RESULT

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Kazuoki Kondo, M.D.

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 20, 2012

Study Start

December 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 6, 2026

Results First Posted

October 3, 2016

Record last verified: 2025-12

Locations

JP(1)