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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: alb-interferon alfa 2b; Drug: peg-interferon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759200

CABF656B2202

Details and patient eligibility

About

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

Enrollment: 525 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

525 participants in 5 patient groups

alb-interferon arm 1

Experimental group

Treatment:

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

alb-interferon arm 2

Experimental group

Treatment:

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

alb-interferon arm 3

Experimental group

Treatment:

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

alb-interferon arm 4

Experimental group

Treatment:

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

Drug: alb-interferon alfa 2b

peg-interferon

Active Comparator group

Treatment:

Drug: peg-interferon