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

Hepatitis C Clinical Trial

Official title:

Phase II Study of MP-424 in Patients With (Genotype 1b) Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621296
• Other study ID #: G060-A7
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2008
• Last updated: April 16, 2014
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Japan	Toranomon Hospital	Kawasaki City	Takatsu-ku

Sponsors (2)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation	Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

Japan, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No