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.
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ClinicalTrials.gov Identifier: NCT01178996 |
Recruitment Status
:
Completed
First Posted
: August 10, 2010
Last Update Posted
: August 10, 2010
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Condition or disease | Intervention/treatment | Phase |
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Chronic Hepatitis C | Biological: Thymosin alpha 1 Drug: Ribavirin Biological: PEGinterferon alfa2a Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 552 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | July 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: Thymosin alpha 1
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).
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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 Name: 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 Name: Copegus
Biological: PEGinterferon alfa2a
180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks
Other Name: Pegasys
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Placebo Comparator: Placebo
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).
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Drug: Ribavirin
Ribavirin 1000 mg (<75 kg) or 1200 mg (>75 kg) daily with food divided in two doses orally for 48 weeks
Other Name: Copegus
Biological: PEGinterferon alfa2a
180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks
Other Name: Pegasys
Drug: Placebo
Placebo
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- Sustained Virological Response (SVR) [ Time Frame: Week 72 ]The proportion of patients who were HCV RNA negative at the end of observation period.
- Sustained Biochemical Response (SBR) [ Time Frame: Week 72 ]The proportion of patients with normal serum ALT at the end of observation period.
- End of Treatment Biochemical Response (EBR) [ Time Frame: Week 48 ]The proportion of patients with normal serum ALT at the end of treatment period.
- End of Treatment Virological Response [EVR] [ Time Frame: Week 48 ]The proportion of patients who were HCV RNA negative at the end of treatment period.
- Safety [ Time Frame: During the treatment period (up to 48 weeks) and the follow-up period (up to 24 weeks) ]Safety and tolerability were evaluated by AEs recording, laboratory (hematology and chemistry), ECG, and vital signs evaluations. All laboratory tests were centralized.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178996
France | |
Hôpital Necker | |
Paris, France, 75743 | |
Germany | |
Universitätsklinikum Tübingen | |
Tübingen, Germany, D-72076 | |
Greece | |
University Hospital of Ioannina | |
Ioannina, Greece, 45 500 | |
Italy | |
Ospedale Casa Sollievo della Sofferenza | |
San Giovanni Rotondo, Foggia, Italy, 71013 | |
Policlinico S.Orsola-Malpighi | |
Bologna, Italy, 40138 | |
Ospedale Cardarelli | |
Napoli, Italy, 80131 | |
Università Cattolica del Sacro Cuore | |
Rome, Italy, 00100 | |
Dipartimento Medico Chirurgico delle Malattie dell'Apparato Digerente e della Nutrizione, Azienda Ospedaliera S Giovanni Battista | |
Turin, Italy, 10126 | |
Spain | |
Hospital del Mar | |
Barcelona, Spain, 08003 |
Principal Investigator: | Mario Rizzetto, MD | Dipartimento Medico Chirurgico delle Malattie dell'Apparato Digerente e della Nutrizione, Azienda Ospedaliera S Giovanni Battista, Corso Bramante 88, Turin, Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Alfonso De Rosa Clinical Research Manager, Sigma-tau SPA |
ClinicalTrials.gov Identifier: | NCT01178996 History of Changes |
Other Study ID Numbers: |
ST1472-DM-03-004 2004-001277-25 ( EudraCT Number ) |
First Posted: | August 10, 2010 Key Record Dates |
Last Update Posted: | August 10, 2010 |
Last Verified: | August 2010 |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Ribavirin Peginterferon alfa-2a Interferon-alpha Peginterferon alfa-2b Thymalfasin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Antineoplastic Agents |