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.

August 9, 2010 updated by: sigma-tau i.f.r. S.p.A.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

552

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75743
        • Hôpital Necker
  • Germany
      • Tübingen, Germany, D-72076
        • Universitätsklinikum Tübingen
  • Greece
      • Ioannina, Greece, 45 500
        • University Hospital of Ioannina
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S.Orsola-Malpighi
      • Napoli, Italy, 80131
        • Ospedale Cardarelli
      • Rome, Italy, 00100
        • Università Cattolica del Sacro Cuore
      • Turin, Italy, 10126
        • Dipartimento Medico Chirurgico delle Malattie dell'Apparato Digerente e della Nutrizione, Azienda Ospedaliera S Giovanni Battista
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Ospedale Casa Sollievo della Sofferenza
  • Spain
      • Barcelona, Spain, 08003
        • Hospital Del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed written informed consent
  2. Age 18
  3. Presence of HCV RNA measured by quantitative PCR
  4. 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)
  5. 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
  6. Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha plus ribavirin
  7. Negative pregnancy test prior (no more than 24 hours) to first study medication dose

Exclusion Criteria:

  1. Use of systemic corticosteroids within 6 months of entry
  2. More than one previous course of therapy with PEGinterferon alpha plus ribavirin
  3. Any other liver disease
  4. Decompensated liver disease based on a history of hepatic encephalopathy, bleeding oesophageal varices, or ascites
  5. Decompensate or advanced liver cirrhosis (ChildPugh B or C)
  6. HIV infection diagnosed by HIV seropositivity and confirmed by Western blot
  7. Insulin-dependent Diabetes Mellitus
  8. Severe haemoglobinopathy
  9. Positive liver and kidney microsomal auto antibodies
  10. Positive anti thyroid antibodies
  11. Pregnancy as documented by a urine pregnancy test
  12. Alcohol or intravenous drug abuse within the previous 1 year
  13. 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
  14. Any indication that the patient would not comply with the conditions of the study protocol
  15. Previous treatment with thymosin alpha 1
  16. Patients with known hypersensitivity to any PEGinterferon and or ribavirin
  17. Patients with a history of severe depression that required either hospitalization or electroshock therapy or depression associated with suicide attempt
  18. Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry
  19. Presence of serious pulmonary or cardiovascular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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).
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
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).
Drug: Placebo
Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virological Response (SVR)
Time Frame: Week 72
The proportion of patients who were HCV RNA negative at the end of observation period.
Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Biochemical Response (SBR)
Time Frame: Week 72
The proportion of patients with normal serum ALT at the end of observation period.
Week 72
End of Treatment Biochemical Response (EBR)
Time Frame: Week 48
The proportion of patients with normal serum ALT at the end of treatment period.
Week 48
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.
Week 48
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.
During the treatment period (up to 48 weeks) and the follow-up period (up to 24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

sigma-tau i.f.r. S.p.A.

Collaborators

SciClone Pharmaceuticals

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

August 9, 2010

First Submitted That Met QC Criteria

August 9, 2010

First Posted (ESTIMATE)

August 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST1472-DM-03-004
  • 2004-001277-25 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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