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

An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00759200

Enrollment

525

Registered

2008-09-25

Start date

2008-10-31

Completion date

2010-12-31

Last updated

2016-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C, genotype 2, genotype 3, albumin interferon alfa-2b, alb-interferon

Brief summary

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

Interventions

DRUGalb-interferon alfa 2b

900 mcg every 4 weeks

DRUGpeg-interferon

Peg-interferon alfa 2a: 180 mcg 1x per wk.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Adverse events	at every visit

Secondary

Measure	Time frame
Viral load	at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.

Countries

Australia, Canada, France, Germany, Greece, India, Italy, Poland, Spain, Taiwan, Thailand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026