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

NCT00630058 | Completed Phase 1 Results

• 1 other identifier: G060-A5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Chronic Hepatitis C; Protease Inhibitor; Telaprevir

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels

  37 weeks

Study Arms (2)

Group A (MP-424 High)

EXPERIMENTAL

Drug: MP-424(H), PEG-IFN-a-2b, RBV

Group B (MP-424 Low)

EXPERIMENTAL

Drug: MP-424 (L), PEG-IFN-a-2b, RBV

Interventions

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

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

Also known as: Telaprevir

Group A (MP-424 High)

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

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

Also known as: Telaprevir

Group B (MP-424 Low)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with genotype 1b chronic hepatitis C

You may not qualify if:

• Patients diagnosed with decompensated cirrhosis
• Patients diagnosed with positive HBs antigen in the test

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead
• Vertex Pharmaceuticals Incorporated: collaborator

Study Sites (1)

Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Location

Related 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 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.

  PMID: 23190247 RESULT

MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

Ribavirin; telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Fumitaka Suzuki, MD

  Department of Hepatology, Toranomon Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 6, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 6, 2026
• Results First Posted: January 18, 2013

Record last verified: 2025-12

Locations

JP (1)