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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin (RBV) in Subjects With (Genotype 1) Hepatitis C Who Did Not Respond to Previous Treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00781274
Enrollment
32
Registered
2008-10-28
Start date
2008-12-31
Completion date
2010-07-31
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

Hepatitis C

Brief summary

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.

Interventions

DRUGMP-424

750 mg every 8 hours for 12 weeks

DRUGRibavirin

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

DRUGPeginterferon Alfa-2b

1.5 mcg/kg/week for 24 weeks

Sponsors

Vertex Pharmaceuticals Incorporated
CollaboratorINDUSTRY
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 1, chronic hepatitis C * Non-responders (patient who did not respond to 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
The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (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
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 24 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 24 weeks
32
Total32

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicMP-424
Age, Continuous55.4 years
STANDARD_DEVIATION 6.4
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
32 / 32
serious
Total, serious adverse events
3 / 32

Outcome results

Primary

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

Time frame: After 24 weeks of follow-up

ArmMeasureValue (NUMBER)
MP-424The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)34.4 percentage of subjects achieving SVR

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