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

Information source: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: MP-424(H), PEG-IFN-a-2b, RBV (Drug); MP-424 (L), PEG-IFN-a-2b, RBV (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mitsubishi Tanabe Pharma Corporation

Official(s) and/or principal investigator(s):
Fumitaka Suzuki, MD, Principal Investigator, Affiliation: Department of Hepatology, Toranomon Hospital

Summary

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.

Clinical Details

Official title: A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Cmax (Maximum Observed Concentration in Plasma) of MP-424

Tmax (Time of Maximum Concentration in Plasma) of MP-424

AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424

Ctrough (Minimum Observed Concentration in Plasma) of MP-424

T1/2(Time of Half-Life) of MP-424

Secondary outcome: Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Toranomon Hospital, Kawasaki City, Takatsu-ku, Japan
Additional Information

Starting date: April 2008
Last updated: April 16, 2014

Page last updated: August 23, 2015

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