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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014