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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 1

Conditions

Hepatitis C

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00630058
G060-A5

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No 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

Trial design

20 participants in 2 patient groups

Group A (MP-424 High)
Experimental group
Treatment:
Drug: MP-424(H), PEG-IFN-a-2b, RBV
Group B (MP-424 Low)
Experimental group
Treatment:
Drug: MP-424 (L), PEG-IFN-a-2b, RBV

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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