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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759200
• Other study ID #: CABF656B2202
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2008
• Last updated: November 15, 2016
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug AdministrationTaiwan: Department of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Drugs Controller General of IndiaCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18 years or older

• Clinical diagnosis of chronic hepatitis C

• Infection with HCV genotype 2 or 3

• No previous IFNa-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

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• alb-interferon alfa 2b
900 mcg every 4 weeks
• alb-interferon alfa 2b
1200 mcg every 4 weeks
• alb-interferon alfa 2b
1500 mcg every 4 weeks
• alb-interferon alfa 2b
1800 mcg every 4 weeks
• peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.

Locations

Country	Name	City	State
Australia	Novartis Investigative site	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
Canada	Novartis Investigative site	Calgary
Canada	Novartis Investigative Site	Downsview
Canada	Novartis Investigative site	Montreal
Canada	Novartis Investigative site	Toronto
Canada	Novartis Investigative site	Vancouver
France	Novartis Investigative Site	Cretail
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Villejuif
Germany	Novartis Investigative Site	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
Greece	Novartis Investigative Site	Heraklion
Greece	Novartis Investigative Site	Loannina
Greece	Novartis Investigative Site	Patra-Rio
Greece	Novartis Investigative Site	Piraeurs
Greece	Novartis Investigative Site	Thessaloniki
India	Novartis Investigative Site	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
Italy	Novartis Investigative site	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
Poland	Novartis Investigative site	Bialystok
Poland	Novartis Investigative site	Lodz
Spain	Novartis Investigative site	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
Taiwan	Novartis Investigative site	Kaohsiung
Taiwan	Novartis Investigative site	Tainan
Taiwan	Novartis Investigative site	Taipei
Thailand	Novartis Investigative site	Bangkok
Thailand	Novartis Investigative site	Chaingmai
Thailand	Novartis Investigative Site	Hat Yai
Thailand	Novartis Investigative Site	Muang
United Kingdom	Novartis Investigative Site	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Human Genome Sciences Inc.

Countries where clinical trial is conducted

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

References & Publications (1)

Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team.. Randomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		at every visit	Yes
Secondary	Viral load		at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.	No

External Links

•   CABF656B2202 Results at Novartis Clinical Trials Results Website