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

Tanabe Pharma Corporation15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

MP-424 (Telaprevir)DRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Outcomes

Primary Outcomes

Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration

Time frame: 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.

Data from ClinicalTrials.gov

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