Title
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C
Phase
Phase 3Lead Sponsor
MerckStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hepatitis CIntervention/Treatment
ribavirin interferon alpha-2b ...Study Participants
130The 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.
1.5 ug/kg/week SC for 12 or 24 weeks
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
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
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)
| Event Type | Organ System | Event Term | PEG-IFN 12 | PEG-IFN 24 | PEG-IFN + RVB 12 |
|---|
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks treatment (depending on treatment arm) was <15 IU/mL.
LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.
ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.
Participants were considered to have RVR if serum HCV RNA level at 2 or 4 weeks of treatment was below the cut off value of the referring local laboratory of each participating site.
Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.
