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A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IDN-6556
Placebo
Sponsored by
Conatus Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic Hospital
  • Scripps Clinic
  • California Pacific Medical Center
  • University of California, San Francisco
  • University of Miami
  • Indiana University School of Medicine
  • Beth Israel Deaconness Medical Center
  • Henry Ford Hospital
  • The Mayo Clinic
  • Mt. Sinai School of Medicine
  • University of North Carolina
  • Duke University Medical Center
  • University of Cincinnati
  • Metrohealth Medical Center
  • Medical College of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

IDN-6556 5 mg twice a day (BID)

IDN-6556 25mg twice a day (BID)

IDN-6556 50 mg twice a day (BID)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 20, 2004
Last Updated
August 9, 2012
Sponsor
Conatus Pharmaceuticals Inc.
Collaborators
Idun Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00088140
Brief Title
A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients
Official Title
A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conatus Pharmaceuticals Inc.
Collaborators
Idun Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
IDN-6556 5 mg twice a day (BID)
Arm Type
Active Comparator
Arm Title
IDN-6556 25mg twice a day (BID)
Arm Type
Active Comparator
Arm Title
IDN-6556 50 mg twice a day (BID)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IDN-6556
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
Title
Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92067
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Beth Israel Deaconness Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mt. Sinai School of Medicine
City
New York City
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27715
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

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