Clinical trial NCT00759200: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
genotype 2
genotype 3
albumin interferon alfa-2b
alb-interferon
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Human Genome Sciences Inc.
First posted: 2008-09-25
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Adverse events
timeFrame: at every visit
Secondary outcomes:
measure: Viral load
timeFrame: at weeks 4, 12 and 24 of treatment and 24 weeks post-treatment.
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Novartis Investigative site
city: Fitzroy
country: Australia
facility: Novartis Investigative site
city: Greenslopes
country: Australia
facility: Novartis Investigative site
city: Kingswood
country: Australia
facility: Novartis Investigative site
city: Melbourne
country: Australia
facility: Novartis Investigative site
city: Westmead
country: Australia
facility: Novartis Investigative site
city: Calgary
country: Canada
facility: Novartis Investigative site
city: Downsview
country: Canada
facility: Novartis Investigative Site
city: Montreal
country: Canada
facility: Novartis Investigative site
city: Toronto
country: Canada
facility: Novartis Investigative site
city: Vancouver
country: Canada
facility: Novartis Investigative site
city: Cretail
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Villejuif
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Düsseldorf
country: Germany
facility: Novartis Investigative site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Heraklion
country: Greece
facility: Novartis Investigative Site
city: Loannina
country: Greece
facility: Novartis Investigative Site
city: Patra-Rio
country: Greece
facility: Novartis Investigative Site
city: Piraeurs
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Chandigarh
country: India
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative site
city: Lucknow
country: India
facility: Novartis Investigative Site
city: Ludhiana
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative site
city: Milano
country: Italy
facility: Novartis Investigative site
city: Napoli
country: Italy
facility: Novartis Investigative site
city: Pavia
country: Italy
facility: Novartis Investigative site
city: Pisa
country: Italy
facility: Novartis Investigative site
city: Polermo
country: Italy
facility: Novartis Investigative site
city: Torino
country: Italy
facility: Novartis Investigative site
city: Bialystok
country: Poland
facility: Novartis Investigative site
city: Lodz
country: Poland
facility: Novartis Investigative site
city: Barcelona
country: Spain
facility: Novartis Investigative site
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Malaga
country: Spain
facility: Novartis Investigative site
city: Oviedo
country: Spain
facility: Novartis Investigative site
city: Sevilla
country: Spain
facility: Novartis Investigative site
city: Valencia
country: Spain
facility: Novartis Investigative site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative site
city: Tainan
country: Taiwan
facility: Novartis Investigative site
city: Taipei
country: Taiwan
facility: Novartis Investigative site
city: Bangkok
country: Thailand
facility: Novartis Investigative site
city: Chaingmai
country: Thailand
facility: Novartis Investigative site
city: Hat Yai
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.