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. | Biotech Hunter

Enrollment

552

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

May 31, 2008

Study Completion Date

July 31, 2009

Conditions

Chronic Hepatitis C

Interventions

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

Trial Locations (9)

Dipartimento Medico Chirurgico delle Malattie dell'Apparato Digerente e della Nutrizione, Azienda Ospedaliera S Giovanni Battista, Turin

Policlinico S.Orsola-Malpighi, Bologna

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

Hôpital Necker, Paris

Ospedale Cardarelli, Napoli

Universitätsklinikum Tübingen, Tübingen

University Hospital of Ioannina, Ioannina

Università Cattolica del Sacro Cuore, Rome

Hospital del Mar, Barcelona