Study 18 of 5428 for search of: Canada
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
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, December 2008
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

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Albinterferon Alfa-2B
U.S. FDA Resources
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

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

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CABF656B2202
Study First Received: September 23, 2008
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00759200  
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
Interferon Type I, Recombinant
Liver Diseases
Hepatitis, Chronic
Interferons
Ribavirin
Hepatitis, Viral, Human
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
RNA Virus Infections
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009