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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


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


Minimum age: 20 Years. Maximum age: 69 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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