Completed
PHASE3
INTERVENTIONAL
NCT01178996
Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of the study was to determine safety and efficacy of 48 weeks treatment with Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and placebo.
Interventions
Name:
Thymosin alpha 1
Type:
BIOLOGICAL
Description:
Thymosin alpha 1 (Zadaxin) 1.6 mg/day, two times weekly in the morning, by subcutaneous injection for 48 weeks.
Name:
Ribavirin
Type:
DRUG
Description:
Ribavirin 1000 mg (\<75 kg) or 1200 mg (\>75 kg) daily with food divided in two doses orally for 48 weeks
Name:
PEGinterferon alfa2a
Type:
BIOLOGICAL
Description:
180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks
Name:
Placebo
Type:
DRUG
Description:
Placebo
Primary Outcomes
Measure:
Sustained Virological Response (SVR)
TimeFrame:
Week 72
Description:
The proportion of patients who were HCV RNA negative at the end of observation period.
Trial Information
NCT ID
NCT01178996
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
sigma-tau i.f.r. S.p.A.
Last Updated
December 15, 2025