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

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: alb-interferon alfa 2b; Drug: peg-interferon

• Registration Number: NCT00759200
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Study Start: 2008-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alb-interferon arm 1	alb-interferon alfa 2b	-
alb-interferon arm 2	alb-interferon alfa 2b	-
alb-interferon arm 3	alb-interferon alfa 2b	-
alb-interferon arm 4	alb-interferon alfa 2b	-
peg-interferon	peg-interferon	-

Primary Outcome Measures

Name	Time	Method
Adverse events	at every visit

Secondary Outcome Measures

Name	Time	Method
Viral load	at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.

Trial Locations

Locations (2)

Novartis Investigative site; 🇹🇭 Chaingmai, Thailand

Novartis Investigative Site; 🇬🇧 Glasgow, United Kingdom