Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Ribavirin; Biological: Pegylated interferon alfa-2b

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00686517

P03552

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with acute hepatitis C virus (HCV).
• Normal and Elevated serum alanine transferase (ALT) levels
• Positive serum HCV-RNA.
• Aged between 18 and 65 years.
• Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion

Exclusion criteria

• Liver disease unrelated to HCV infection
• Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
• Women with ongoing pregnancy or who are breast feeding
• History of severe psychiatric disease, especially depression
• History of neurologic disease, especially epilepsy
• History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
• Positive anti-Human Immunodeficiency Virus (HIV) antibodies
• Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
• Positive Hepatitis B surface antigen (HBsAg)
• History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
• History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

PEG-IFN 24

Experimental group

Description:

pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks

Treatment:

Biological: Pegylated interferon alfa-2b

PEG-IFN 12

Experimental group

Description:

pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks

Treatment:

Biological: Pegylated interferon alfa-2b

PEG-IFN + RVB 12

Experimental group

Description:

pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

Treatment:

Biological: Pegylated interferon alfa-2b

Drug: Ribavirin