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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724776
First Posted: July 30, 2008
Last Update Posted: August 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation [ Time Frame: 5 weeks after single dose ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724776


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

Responsible Party: Novartis Pharmaceuticals, Japan, Novartis
ClinicalTrials.gov Identifier: NCT00724776     History of Changes
Other Study ID Numbers: CABF656A1202
First Submitted: July 28, 2008
First Posted: July 30, 2008
Last Update Posted: August 11, 2010
Last Verified: August 2010

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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
Immunologic Factors
Physiological Effects of Drugs