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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 23, 2008

Last Updated Date

April 23, 2009

Start Date ^†

October 2008

Current Primary Outcome Measures ^†

Adverse events [ Time Frame: at every visit ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00759200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Viral load [ Time Frame: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Condition ^†

Chronic Hepatitis C

Intervention ^†

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

525

Completion Date

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis Pharmaceuticals

+41 61 324 1111

Location Countries ^†

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

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00759200

Responsible Party

External Affairs, Novartis

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Human Genome Sciences

Investigators ^†

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.