A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C

NCT ID: NCT00630058

Last Updated: 2026-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A (MP-424 High)

Group Type EXPERIMENTAL

MP-424(H), PEG-IFN-a-2b, RBV

Intervention Type DRUG

MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Group B (MP-424 Low)

Group Type EXPERIMENTAL

MP-424 (L), PEG-IFN-a-2b, RBV

Intervention Type DRUG

MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Interventions

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MP-424(H), PEG-IFN-a-2b, RBV

MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Intervention Type DRUG

MP-424 (L), PEG-IFN-a-2b, RBV

MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Telaprevir Telaprevir

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with genotype 1b chronic hepatitis C

Exclusion Criteria

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs antigen in the test
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role collaborator

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fumitaka Suzuki, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatology, Toranomon Hospital

Locations

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Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Site Status

Countries

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Japan

References

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Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.

Reference Type RESULT
PMID: 23190247 (View on PubMed)

Other Identifiers

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G060-A5

Identifier Type: -

Identifier Source: org_study_id

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