Phase 3
N=130
Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00686517 ↗Enrolled (actual)
130
Serious AEs
8.5%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period — 23; 20; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pegylated interferon alfa-2b (Biological); Ribavirin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period |
23; 20; 21 | — |
| SECONDARY Virologic Response at the End of Treatment Follow-up (ETR) |
26; 28; 27 | — |
| SECONDARY Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]). |
20; 19; 19 | — |
| SECONDARY Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization |
28; 31; 32; 31; 27; 28 | — |
| SECONDARY Number of Participants With Rapid Virologic Response (RVR) |
24; 25; 23; 28; 35; 34 | — |
| SECONDARY Number of Peripheral Blood Mononuclear Cells (PBMCs) |
— | — |
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) 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)
Data sourced from ClinicalTrials.gov (NCT00686517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.