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.

A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterferon Alpha-2a + Ribavirin + Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: sigma-tau i.f.r. S.p.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	Thymosin alpha 1	Thymosin alpha 1 (Zadaxin) 1.6 mg/day, two times weekly in the morning, by subcutaneous injection for 48 weeks.
DRUG	Ribavirin	Ribavirin 1000 mg (\<75 kg) or 1200 mg (\>75 kg) daily with food divided in two doses orally for 48 weeks
BIOLOGICAL	PEGinterferon alfa2a	180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks
DRUG	Placebo	Placebo

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-05-01
• Completion: 2009-07-01
• First posted: 2010-08-10
• Last updated: 2010-08-10

Locations

9 sites across 5 countries: France, Germany, Greece, Italy, Spain