Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C
Intervention: Albinterferon alfa 2b (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: Novartis
Summary
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
Clinical Details
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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety and tolerability after single dose
Secondary outcome: Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
Eligibility
Minimum age: 20 Years.
Maximum age: 69 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, Japan, Tokyo, Japan
Additional Information
Starting date: July 2008
Last updated: August 10, 2010
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