Trial | NCT01178996  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    552
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.
Study Started
Dec 31
2004
Primary Completion
May 31
2008
Study Completion
Jul 31
2009
Last Update
Aug 10
2010
Estimate

Biological Thymosin alpha 1

Thymosin alpha 1 (Zadaxin) 1.6 mg/day, two times weekly in the morning, by subcutaneous injection for 48 weeks.

  • Other names: Zadaxin

Drug Ribavirin

Ribavirin 1000 mg (<75 kg) or 1200 mg (>75 kg) daily with food divided in two doses orally for 48 weeks

  • Other names: Copegus

Biological PEGinterferon alfa2a

180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks

  • Other names: Pegasys

Drug Placebo

Placebo

Thymosin alpha 1 Experimental

Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).

Placebo Placebo Comparator

Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).

Criteria 

Inclusion Criteria:

Signed written informed consent
Age 18
Presence of HCV RNA measured by quantitative PCR
Non responder to previous approved doses of therapy with PEGinterferon alpha plus ribavirin. Patients must have been treated for at least 12 weeks with documented HCV RNA quantitative not showing major of 2 log10 HCV RNA reduction or patients treated for at least 24 weeks with documented HCV RNA qualitative not showing a virological response (viral RNA clearance)
Liver biopsy consistent with a diagnosis of chronic hepatitis C or histological cirrhosis. Biopsy will not be required if the patient can produce a biopsy performed within the year preceding the randomization day and was performed at least 6 months after the end of the latter course of therapy
Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha plus ribavirin
Negative pregnancy test prior (no more than 24 hours) to first study medication dose

Exclusion Criteria:

Use of systemic corticosteroids within 6 months of entry
More than one previous course of therapy with PEGinterferon alpha plus ribavirin
Any other liver disease
Decompensated liver disease based on a history of hepatic encephalopathy, bleeding oesophageal varices, or ascites
Decompensate or advanced liver cirrhosis (ChildPugh B or C)
HIV infection diagnosed by HIV seropositivity and confirmed by Western blot
Insulin-dependent Diabetes Mellitus
Severe haemoglobinopathy
Positive liver and kidney microsomal auto antibodies
Positive anti thyroid antibodies
Pregnancy as documented by a urine pregnancy test
Alcohol or intravenous drug abuse within the previous 1 year
Patients who are in poor medical or psychiatric conditions, or who have any non-malignant systemic disease that, in the opinion of the Investigator, would make it unlikely that the patient could complete the study protocol
Any indication that the patient would not comply with the conditions of the study protocol
Previous treatment with thymosin alpha 1
Patients with known hypersensitivity to any PEGinterferon and or ribavirin
Patients with a history of severe depression that required either hospitalization or electroshock therapy or depression associated with suicide attempt
Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry
Presence of serious pulmonary or cardiovascular disorders
No Results Posted