Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Collaborator: Human Genome Sciences Inc.
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.