Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
NCT ID: NCT00686517
Last Updated: 2017-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2003-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-IFN 24
pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
PEG-IFN 12
pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
PEG-IFN + RVB 12
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
Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
Ribavirin
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Interventions
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Pegylated interferon alfa-2b
1.5 ug/kg/week SC for 12 or 24 weeks
Ribavirin
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Bioikos Ambiente Srl
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, Angarano G; Acute Hepatitis C Study Group. Acute hepatitis C: a 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin. Hepatology. 2014 Jun;59(6):2101-9. doi: 10.1002/hep.26991. Epub 2014 Apr 29.
Other Identifiers
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P03552
Identifier Type: -
Identifier Source: org_study_id
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