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Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00724776
First received: July 28, 2008
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients


Condition Intervention Phase
Chronic Hepatitis C
 Biological: Albinterferon alfa 2b
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Dose of Albinterferon Alfa 2b (Alb-IFN), Recombinant Human Albumin-interferon Alfa Fusion Protein in Japanese Chronic Hepatitis C Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability after single dose [ Time Frame: 5 weeks after single dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation [ Time Frame: 5 weeks after single dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Open-label treatment with albinterferon alfa 2b escalating single dose
 Biological: Albinterferon alfa 2b
recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period.
  • Age 20 to 69 years
  • Have compensated liver disease results on screening laboratory assessment

Exclusion Criteria:

  • Evidence of decompensated liver disease and/or liver cirrhosis.
  • Body weight < 50 kg.
  • A history of immunologically mediated disease.
  • A history or other clinical evidence of interstitial lung disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724776

Locations
Japan
Novartis Pharmaceuticals, Japan
Tokyo, Japan
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals, Japan, Novartis
ClinicalTrials.gov Identifier: NCT00724776     History of Changes
Other Study ID Numbers: CABF656A1202
Study First Received: July 28, 2008
Last Updated: August 10, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013