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Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients
This study is currently recruiting participants.
Verified by Novartis, April 2009
First Received: September 23, 2008   Last Updated: April 23, 2009   History of Changes
Sponsors and Collaborators: Novartis
Human Genome Sciences
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00759200
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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:


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
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
alb-interferon arm 1: Experimental Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
alb-interferon arm 2: Experimental Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
alb-interferon arm 3: Experimental Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
alb-interferon arm 4: Experimental Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
peg-interferon: Active Comparator Drug: peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.

  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

Contacts
Contact: Novartis Pharmaceuticals +41 61 324 1111

  Show 55 Study Locations
Sponsors and Collaborators
Novartis
Human Genome Sciences
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CABF656B2202
Study First Received: September 23, 2008
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00759200     History of Changes
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 - French Health Products Safety Agency;   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

Study placed in the following topic categories:
Interferon-alpha
Anti-Infective Agents
Interferon Type I, Recombinant
Liver Diseases
Immunologic Factors
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents
Growth Inhibitors
Interferon-alpha
RNA Virus Infections
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

ClinicalTrials.gov processed this record on September 11, 2009