Back to resultsAlbinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Albinterferon alfa 2b
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
Eligibility 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
Sites / Locations
- Novartis Pharmaceuticals, Japan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Open-label treatment with albinterferon alfa 2b escalating single dose
Outcomes
Primary Outcome Measures
Safety and tolerability after single dose
Secondary Outcome Measures
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724776
Brief Title
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic hepatitis C, Albinterferon alfa 2b, phase I, Japan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Open-label treatment with albinterferon alfa 2b escalating single dose
Intervention Type
Biological
Intervention Name(s)
Albinterferon alfa 2b
Intervention Description
recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0
Primary Outcome Measure Information:
Title
Safety and tolerability after single dose
Time Frame
5 weeks after single dose
Secondary Outcome Measure Information:
Title
Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
Time Frame
5 weeks after single dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novartis Pharmaceuticals, Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3261
Description
Results for CABF656A1202 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
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