Status:
COMPLETED
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.
Lead Sponsor:
sigma-tau i.f.r. S.p.A.
Collaborating Sponsors:
SciClone Pharmaceuticals
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 adu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT01178996
Start Date
December 1 2004
End Date
July 1 2009
Last Update
August 10 2010
Active Locations (9)
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1
Hôpital Necker
Paris, France, 75743
2
Universitätsklinikum Tübingen
Tübingen, Germany, D-72076
3
University Hospital of Ioannina
Ioannina, Greece, 45 500
4
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013