Phase 1
Completed N=20
A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Source: ClinicalTrials.gov NCT00630058 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Jan 2013
Primary outcomePrimary: Cmax (Maximum Observed Concentration in Plasma) of MP-424 — 1.62; 1.45; 3.96; 3.06 μg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximum Observed Concentration in Plasma) of MP-424 |
1.62; 1.45; 3.96; 3.06; 3.67; 3.16 | — |
| PRIMARY Tmax (Time of Maximum Concentration in Plasma) of MP-424 |
2.51; 2.54; 2.50; 2.45; 3.24; 2.43 | — |
| PRIMARY AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 |
7.53; 6.55; 26.00; 19.94; 25.00; 21.35 | — |
| PRIMARY Ctrough (Minimum Observed Concentration in Plasma) of MP-424 |
0.846; 0.681; 2.639; 1.914; 2.679; 2.105 | — |
| PRIMARY T1/2(Time of Half-Life) of MP-424 |
4.87; 4.03; 9.99; 10.00; 9.06; 6.22 | — |
| SECONDARY Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels |
-0.190; -0.220; -0.420; -0.390; -1.300; -1.310 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00630058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.