Status:
COMPLETED
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Bioikos Ambiente Srl
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 he...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00686517
Start Date
December 1 2003
End Date
December 1 2010
Last Update
April 5 2017
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