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

Condition(s) targeted: Chronic Hepatitis C

Intervention: alb-interferon alfa 2b (Drug); alb-interferon alfa 2b (Drug); alb-interferon alfa 2b (Drug); alb-interferon alfa 2b (Drug); peg-interferon (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +41 61 324 1111

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

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

Primary outcome: Adverse events

Secondary outcome: Viral load

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Novartis Pharmaceuticals, Phone: +41 61 324 1111

Novartis Investigative site, Kingswood, Australia; Recruiting

Novartis Investigative site, Westmead, Australia; Recruiting

Novartis Investigative site, Clayton, Australia; Recruiting

Novartis Investigative site, Fitzroy, Australia; Recruiting

Novartis Investigative site, Greenslopes, Australia; Recruiting

Novartis Investigative site, Melbourne, Australia; Recruiting

Novartis Investigative site, Vancouver, Canada; Recruiting

Novartis Investigative site, Calgary, Canada; Recruiting

Novartis Investigative site, Toronto, Canada; Recruiting

Novartis Investigative site, Montreal, Canada; Recruiting

Novartis Investigative Site, Downsview, Canada; Recruiting

Novartis Investigative Site, Cretail, France; Recruiting

Novartis Investigative Site, Paris, France; Recruiting

Novartis Investigative Site, Villejuif, France; Recruiting

Novartis Investigative Site, Nice, France; Recruiting

Novartis Investigative site, Düsseldorf, Germany; Recruiting

Novartis Investigative Site, Berlin, Germany; Recruiting

Novartis Investigative Site, Freiburg, Germany; Recruiting

Novartis Investigative Site, Hamburg, Germany; Recruiting

Novartis Investigative Site, Köln, Germany; Recruiting

Novartis Investigative Site, Essen, Germany; Recruiting

Novartis Investigative Site, Thessaloniki, Greece; Recruiting

Novartis Investigative Site, Patra-Rio, Greece; Recruiting

Novartis Investigative Site, Piraeurs, Greece; Recruiting

Novartis Investigative Site, Loannina, Greece; Recruiting

Novartis Investigative Site, Heraklion, Greece; Recruiting

Novartis Investigative Site, Ludhiana, India; Recruiting

Novartis Investigative Site, Chandigarh, India; Recruiting

Novartis Investigative Site, New Delhi, India; Recruiting

Novartis Investigative Site, Lucknow, India; Recruiting

Novartis Investigative Site, Mumbai, India; Recruiting

Novartis Investigative site, Hyderabad, India; Recruiting

Novartis Investigative site, Milano, Italy; Recruiting

Novartis Investigative site, Bologna, Italy; Recruiting

Novartis Investigative site, Torino, Italy; Recruiting

Novartis Investigative site, Polermo, Italy; Recruiting

Novartis Investigative site, Napoli, Italy; Recruiting

Novartis Investigative site, Pavia, Italy; Recruiting

Novartis Investigative site, Pisa, Italy; Recruiting

Novartis Investigative site, Bialystok, Poland; Recruiting

Novartis Investigative site, Lodz, Poland; Recruiting

Novartis Investigative site, Barcelona, Spain; Recruiting

Novartis Investigative site, Madrid, Spain; Recruiting

Novartis Investigative site, Sevilla, Spain; Recruiting

Novartis Investigative site, Valencia, Spain; Recruiting

Novartis Investigative site, Oviedo, Spain; Recruiting

Novartis Investigative site, Malaga, Spain; Recruiting

Novartis Investigative site, Tainan, Taiwan; Recruiting

Novartis Investigative site, Kaohsiung, Taiwan; Recruiting

Novartis Investigative site, Taipei, Taiwan; Recruiting

Novartis Investigative site, Bangkok, Thailand; Recruiting

Novartis Investigative site, Chaingmai, Thailand; Recruiting

Novartis Investigative Site, Muang, Thailand; Recruiting

Novartis Investigative Site, Hat Yai, Thailand; Recruiting

Novartis Investigative Site, Glasgow, United Kingdom; Recruiting

Starting date: October 2008
Last updated: April 23, 2009