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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00630058

Enrollment

Registered

2008-03-06

Start date

2008-04-30

Completion date

2009-03-31

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Chronic Hepatitis C, Protease Inhibitor, Telaprevir

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.

Interventions

DRUGMP-424(H), PEG-IFN-a-2b, RBV

MP-424 (three tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

DRUGMP-424 (L), PEG-IFN-a-2b, RBV

MP-424 (two tablets of 250mg tablet at a time, every 8 hours) + PEG-IFN-a-2b + RBV for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Group A (MP-424 High) Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks	10
Group B (MP-424 Low) Drug: MP-424 500 mg every 8 hours for 12 weeks Other Name: Telaprevir Drug: Ribavirin 600 - 1000 mg/day based on body weight for 12 weeks Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week for 12 weeks	10
Total	20

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	stopping criteria	3	2
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Group A (MP-424 High)	Group B (MP-424 Low)	Total
Age, Continuous	50.1 years STANDARD_DEVIATION 6.8	54.3 years STANDARD_DEVIATION 8.5	52.2 years STANDARD_DEVIATION 7.8
Sex: Female, Male Female	4 Participants	6 Participants	10 Participants
Sex: Female, Male Male	6 Participants	4 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	10 / 10	10 / 10
serious Total, serious adverse events	2 / 10	2 / 10

Outcome results

Primary

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.