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

November 15, 2016 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

525

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia
        • Novartis Investigative Site
      • Fitzroy, Australia
        • Novartis Investigative Site
      • Greenslopes, Australia
        • Novartis Investigative Site
      • Kingswood, Australia
        • Novartis Investigative Site
      • Melbourne, Australia
        • Novartis Investigative Site
      • Westmead, Australia
        • Novartis Investigative Site
  • Canada
      • Calgary, Canada
        • Novartis Investigative Site
      • Downsview, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Toronto, Canada
        • Novartis Investigative Site
      • Vancouver, Canada
        • Novartis Investigative Site
  • France
      • Cretail, France
        • Novartis Investigative Site
      • Nice, France
        • Novartis Investigative Site
      • Paris, France
        • Novartis Investigative Site
      • Villejuif, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Düsseldorf, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Freiburg, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Köln, Germany
        • Novartis Investigative Site
  • Greece
      • Heraklion, Greece
        • Novartis Investigative Site
      • Loannina, Greece
        • Novartis Investigative Site
      • Patra-Rio, Greece
        • Novartis Investigative Site
      • Piraeurs, Greece
        • Novartis Investigative Site
      • Thessaloniki, Greece
        • Novartis Investigative Site
  • India
      • Chandigarh, India
        • Novartis Investigative Site
      • Hyderabad, India
        • Novartis Investigative Site
      • Lucknow, India
        • Novartis Investigative Site
      • Ludhiana, India
        • Novartis Investigative Site
      • Mumbai, India
        • Novartis Investigative Site
      • New Delhi, India
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Napoli, Italy
        • Novartis Investigative Site
      • Pavia, Italy
        • Novartis Investigative Site
      • Pisa, Italy
        • Novartis Investigative Site
      • Polermo, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland
        • Novartis Investigative Site
      • Lodz, Poland
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Oviedo, Spain
        • Novartis Investigative Site
      • Sevilla, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Novartis Investigative Site
      • Tainan, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand
        • Novartis Investigative Site
      • Chaingmai, Thailand
        • Novartis Investigative Site
      • Hat Yai, Thailand
        • Novartis Investigative Site
      • Muang, Thailand
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: alb-interferon arm 1
Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
Other Names:
  • ABF656
Experimental: alb-interferon arm 2
Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
Other Names:
  • ABF656
Experimental: alb-interferon arm 3
Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
Other Names:
  • ABF656
Experimental: alb-interferon arm 4
Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
Other Names:
  • ABF656
Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
Other Names:
  • ABF656
Active Comparator: peg-interferon
Drug: peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.
Other Names:
  • peg-IFN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: at every visit
at every visit

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Human Genome Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 15, 2016

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABF656B2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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