A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00088140

Enrollment

204

Registered

2004-07-21

Start date

2004-07-31

Completion date

2005-10-31

Last updated

2012-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Brief summary

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.

Interventions

DRUGIDN-6556

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10	—
Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026