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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (MP-424 High)<br> | Drug: MP-424(H), PEG-IFN-a-2b, RBV<br>* MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks<br>* Other names: Telaprevir;|
| Experimental: Group B (MP-424 Low)<br> | Drug: MP-424 (L), PEG-IFN-a-2b, RBV<br>* MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks<br>* Other names: Telaprevir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum Observed Concentration in Plasma) of MP-424 | 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. | Data were collected at Day1 to Day85 | 
| Tmax (Time of Maximum Concentration in Plasma) of MP-424 | 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. | Data were collected at Day1 to Day85 | 
| AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 | 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. | Data were collected at Day1 to Day85 | 
| Ctrough (Minimum Observed Concentration in Plasma) of MP-424 | 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. | Data were collected at Day1 to Day85 | 
| T1/2(Time of Half-Life) of MP-424 | 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. | Data were collected at Day1 to Day85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels | 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. | 37 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Protease Inhibitor, Telaprevir