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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

July 28, 2008
August 10, 2010
July 2008
July 2009   (final data collection date for primary outcome measure)
Safety and tolerability after single dose [ Time Frame: 5 weeks after single dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00724776 on ClinicalTrials.gov Archive Site
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation [ Time Frame: 5 weeks after single dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
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.

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
Biological: Albinterferon alfa 2b
recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
Experimental: 1
Open-label treatment with albinterferon alfa 2b escalating single dose
Intervention: Biological: Albinterferon alfa 2b
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
July 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00724776
CABF656A1202
No
Novartis Pharmaceuticals, Japan, Novartis
Novartis
Not Provided
Not Provided
Novartis
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP