Status:
COMPLETED
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
Lead Sponsor:
Novartis
Collaborating Sponsors:
Human Genome Sciences Inc.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
Eligibility Criteria
Inclusion
- Age of 18 years or older
- Clinical diagnosis of chronic hepatitis C
- Infection with HCV genotype 2 or 3
- No previous IFNα-based therapy
Exclusion
- Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
- Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
- History or current evidence of decompensated liver disease; other forms of liver disease
- Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of moderate, severe or uncontrolled psychiatric disease
- History of seizure disorder
- History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
- Clinically significant findings on eye/retinal examination
- History of immunologically mediated disease
- Organ transplantation other than cornea or hair transplant
- History of clinically significant hemoglobinopathy
- Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
- History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
- Received systemic corticosteroids (prednisone equivalent of \> 10 mg/day) within 14 days prior to Baseline visit
- Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
- Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
- Have a clinically significant laboratory abnormality
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT00759200
Start Date
October 1 2008
End Date
December 1 2010
Last Update
November 16 2016
Active Locations (55)
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1
Novartis Investigative site
Clayton, Australia
2
Novartis Investigative site
Fitzroy, Australia
3
Novartis Investigative site
Greenslopes, Australia
4
Novartis Investigative site
Kingswood, Australia