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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630058
• Other study ID #: G060-A5
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2008
• Last updated: April 16, 2014
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• MP-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
• MP-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

Locations

Country	Name	City	State
Japan	Toranomon Hospital	Kawasaki City	Takatsu-ku

Sponsors (2)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation	Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
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.	Data were collected at Day1 to Day85	No
Primary	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	No
Primary	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	No
Secondary	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	No