NCT00621296

Brief Summary

The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 19, 2012

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

February 12, 2008

Results QC Date

September 19, 2012

Last Update Submit

December 15, 2025

Conditions

Keywords

Chronic Hepatitis CProtease Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration

    24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.

Study Arms (1)

MP-424

EXPERIMENTAL
Drug: MP-424 (Telaprevir)

Interventions

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

Also known as: Telaprevir
MP-424

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients diagnosed with decompensated cirrhosis
  • Patients diagnosed with positive HBs antigen in the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation

Study Officials

  • Fumitaka Suzuki, MD

    Department of Hepatology, Toranomon Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

January 6, 2026

Results First Posted

October 19, 2012

Record last verified: 2025-12

Locations