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

Purpose

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

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: alb-interferon alfa 2b Drug: peg-interferon	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Interferon Alfa-2a Interferon Alfa-2b Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

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 ]

Estimated Enrollment:	525
Study Start Date:	October 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: alb-interferon arm 1	Drug: alb-interferon alfa 2b 900 mcg every 4 weeks Other Name: ABF656
Experimental: alb-interferon arm 2	Drug: alb-interferon alfa 2b 1200 mcg every 4 weeks Other Name: ABF656
Experimental: alb-interferon arm 3	Drug: alb-interferon alfa 2b 1500 mcg every 4 weeks Other Name: ABF656
Experimental: alb-interferon arm 4	Drug: alb-interferon alfa 2b 1800 mcg every 4 weeks Other Name: ABF656
Active Comparator: peg-interferon	Drug: peg-interferon Peg-interferon alfa 2a: 180 mcg 1x per wk. Other Name: peg-IFN

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759200

Show 55 Study Locations

Sponsors and Collaborators

Novartis

Human Genome Sciences Inc., a GSK Company

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00759200 History of Changes
Other Study ID Numbers:	CABF656B2202
Study First Received:	September 23, 2008
Last Updated:	April 18, 2011
Health Authority:	Thailand: Food and Drug Administration Taiwan: Department of Health Australia: Department of Health and Ageing Therapeutic Goods Administration India: Drugs Controller General of India Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Novartis:

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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a

Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 23, 2013