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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: MP-424 (L), PEG-IFN-a-2b, RBV; Drug: MP-424(H), PEG-IFN-a-2b, RBV

• Registration Number: NCT00630058
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-24
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-06
• Study Start: 2008-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2012-12-12
• Results First Submitted QC: 2012-12-12
• Results First Posted: 2013-01-18
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients diagnosed with genotype 1b chronic hepatitis C

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (MP-424 Low)	MP-424 (L), PEG-IFN-a-2b, RBV	-
Group A (MP-424 High)	MP-424(H), PEG-IFN-a-2b, RBV	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Observed Concentration in Plasma) of MP-424	Data were collected at Day1 to Day85	Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.; Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Tmax (Time of Maximum Concentration in Plasma) of MP-424	Data were collected at Day1 to Day85	Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.; Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424	Data were collected at Day1 to Day85	Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.; Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
Ctrough (Minimum Observed Concentration in Plasma) of MP-424	Data were collected at Day1 to Day85	Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.; Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.
T1/2(Time of Half-Life) of MP-424	Data were collected at Day1 to Day85	Data were collected before the first dose in the morning, and at 1, 2.5, 4, 6, 8, 12, 16 and 24 h after the first dose on days 1, 14 and 85.; Data as pre-dose were collected at Day3, Day8, Day29, Day43 and Day57.

Secondary Outcome Measures

Name	Time	Method
Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels	37 weeks	HCV RNA concentrations were determined using the COBAS TaqMan HCV test (Roche Diagnostics). The linear dynamic range of the assay was 1.2-7.8 log10 IU/mL.

Trial Locations

Locations (1)

Toranomon Hospital; 🇯🇵 Kawasaki City, Takatsu-ku, Japan