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OpenTrials
Completed

NCT Number: NCT00088140

A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic hepatitis C infection
  • Unsuccessful prior HCV treatment
  • Liver impairment (either AST or ALT 1.5-10.0 x ULN)
  • Alpha-fetoprotein <= 50 ng/mL
  • Adequate hematologic parameters

Exclusion criteria

  • Decompensated or severe liver disease
  • Hepatocellular carcinoma
  • HIV infection
  • Co-infection with hepatitis B virus (HBV)
  • Renal impairment
  • Pancreatitis
  • Use of illicit or drugs of abuse
  • History of alcohol abuse
  • Presence of clinically significant cardiac arrhythmias
  • If female, pregnant or lactating

Treatment and study plan

IDN-6556

Drug

Placebo

Drug

Primary outcomes

  1. Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10

  2. Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10

Sponsors and collaborators

Lead sponsor

Conatus Pharmaceuticals Inc.

Industry

Collaborators

  • Idun Pharmaceuticals

Registry information

Official study title

A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jul 21, 2004
Registry last updated
Aug 13, 2012

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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