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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Relapser Genotype 2 Hepatitis C Infected Patients

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin in Subjects With Genotype 2 Hepatitis C, Who Relapsed After Previous Treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01466192
Enrollment
108
Registered
2011-11-07
Start date
2012-05-31
Completion date
2013-08-31
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Genotype 2

Brief summary

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.

Interventions

DRUGRibavirin

400 - 1000 mg/day based on body weight for 24 weeks

DRUGPeginterferon alfa-2b

1.5mcg/kg/week for 24 weeks

DRUGMP-424 (generic name:Telaprevir)

750mg q8h for 12 weeks

Sponsors

Tanabe Pharma Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Genotype 2, chronic hepatitis C * 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 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

Design outcomes

Primary

MeasureTime frame
Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)After 24 weeks of follow-up

Countries

Japan

Participant flow

Participants by arm

ArmCount
MP-424
MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks
108
Total108

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision1
Overall StudyWithdrawal by Subject3

Baseline characteristics

CharacteristicMP-424
Age, Continuous56.1 years
STANDARD_DEVIATION 8
Sex: Female, Male
Female
55 Participants
Sex: Female, Male
Male
53 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
108 / 108
serious
Total, serious adverse events
12 / 108

Outcome results

Primary

Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

Time frame: After 24 weeks of follow-up

ArmMeasureValue (NUMBER)
MP-424Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)88.0 percentage of subjects achieving SVR

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026