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Completed

NCT Number: NCT00724776

Albinterferon Alfa 2b Single Dose 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

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Pharmaceuticals, Japan

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albinterferon alfa 2b

Biological

recombinant human albumin-interferon alfa fusion protein, 600-1800mcg single dose by S.C. on Day 0

Primary outcomes

  1. Safety and tolerability after single dose

    Time frame: 5 weeks after single dose

Secondary outcomes

  1. Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation

    Time frame: 5 weeks after single dose

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
First posted
Jul 30, 2008
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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