Clinical trial NCT00686517: Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Bioikos Ambiente Srl
First posted: 2008-05-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
timeFrame: Evaluated at the end of 6 months
Secondary outcomes:
measure: Virologic Response at the End of Treatment Follow-up (ETR)
timeFrame: At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
measure: Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
timeFrame: At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
measure: Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
timeFrame: Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
measure: Number of Participants With Rapid Virologic Response (RVR)
timeFrame: Evaluated at 2 and 4 weeks of treatment
measure: Number of Peripheral Blood Mononuclear Cells (PBMCs)
timeFrame: Treatment Weeks 2, 4, 8, and 12
Other outcomes:
Locations:
Study officials:
References:
citation: 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.