At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
MP-424(H), PEG-IFN-a-2b, RBV +1 moredrug
Likely dose
MP-424(H), PEG-IFN-a-2b, RBV 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating MP-424(H), PEG-IFN-a-2b, RBV and MP-424 (L), PEG-IFN-a-2b, RBV for Hepatitis C. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesJapan
CollaboratorsVertex Pharmaceuticals Incorporated
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartApr 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedMar 6, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.3 years ago
Interventions
MP-424(H), PEG-IFN-a-2b, RBVdrug
MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks
MP-424 (L), PEG-IFN-a-2b, RBVdrug
MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks