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-424Tmax (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
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