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Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder 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 Did Not Respond to Previous Treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01468584
Enrollment
10
Registered
2011-11-09
Start date
2011-11-30
Completion date
2013-09-30
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 did not respond to previous treatment.

Interventions

DRUGMP-424 (generic name:Telaprevir)

750mg q8h for 12 weeks

DRUGRibavirin

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

DRUGPeginterferon alfa-2b

1.5mcg/kg/week for 24 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 * 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
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
10
Total10

Baseline characteristics

CharacteristicMP-424
Age, Continuous56.8 years
STANDARD_DEVIATION 6.7
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
10 / 10
serious
Total, serious adverse events
0 / 10

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)50.0 percentage of subjects achieving SVR

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