Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C

NCT ID: NCT00621296

Last Updated: 2026-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to assess the efficacy and safety after administration of MP-424 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MP-424

Group Type EXPERIMENTAL

MP-424 (Telaprevir)

Intervention Type DRUG

Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)

Interventions

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MP-424 (Telaprevir)

Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)

Intervention Type DRUG

Other Intervention Names

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Telaprevir

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with genotype 1b chronic hepatitis C
* Patients naive to the concomitant medications with interferon

Exclusion Criteria

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

20 Years

Maximum Eligible Age

70 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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Toyota J, Ozeki I, Karino Y, Asahina Y, Izumi N, Takahashi S, Kawakami Y, Chayama K, Kamiya N, Aoki K, Yamada I, Suzuki Y, Suzuki F, Kumada H. Virological response and safety of 24-week telaprevir alone in Japanese patients infected with hepatitis C virus subtype 1b. J Viral Hepat. 2013 Mar;20(3):167-73. doi: 10.1111/j.1365-2893.2012.01640.x. Epub 2012 Jul 13.

Reference Type RESULT
PMID: 23383655 (View on PubMed)

Other Identifiers

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G060-A7

Identifier Type: -

Identifier Source: org_study_id

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