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Study of CTS-1027 in Hepatitis C Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of CTS-1027 in Hepatitis C Patients

A Dose Response Study of CTS-1027 in Hepatitis C Patients

NCT00570336•Conatus Pharmaceuticals Inc.

Summary

The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in patients with chronic HCV infection.

Detailed Description

Randomized, placebo-controlled, double-blind, parallel group, multicenter, dose response trial utilizing four doses of CTS-1027, administered orally once daily, in outpatients with chronic hepatitis C virus (HCV) infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
•A history of chronic HCV infection
•Unsuccessful HCV treatment defined as one or more of the following criteria:
•1. Failure to achieve a virologic response during previous therapy, or
•2. Failure to tolerate therapy, or
•3. Failure to maintain a sustained virologic response, or
•4. In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon based therapy
•Liver impairment, as defined by either aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels 1.5 - 7 x ULN on at least two occasions, seven or more days apart, during the baseline period
•Alpha-fetoprotein (AFP) \<= 50 ng/mL
•Hemoglobin \>= 10 g/dL, platelet count \>= 75 x 109/L, and white blood cell count \>= 1.5 x 109/L
+1 more criteria

Exclusion Criteria

•Decompensated or severe liver disease defined by one or more of the following criteria:
•1. Prior liver biopsy showing cirrhosis
•2. Prior liver biopsy showing bridging fibrosis (Metavir \>2 or Ishak \>3) more than 2 years ago in the absence of newer liver biopsy results
•3. Prothrombin time: 3 seconds \> control
•4. Total bilirubin \>= 1.5 x Upper limit of the normal range (ULN), or \> 3 x ULN for unconjugated bilirubin
•5. Serum albumin below normal limits
•6. AST or ALT \> 7 x ULN during baseline period
•7. Evidence of portal hypertension including:
•Splenomegaly or evidence of portal hypertension (i.e., enlarged portal vein and varices) on ultrasound,
•Varices in esophagogastroduodenoscopy (EGD); or
+18 more criteria

Locations (19)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Scripps Clinic

La Jolla, California, United States

Kaiser Permanente

San Diego, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of Colorado Denver

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

West Bloomfield, Michigan, United States

Key Dates

Start Date

December 1, 2007

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

September 16, 2010

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis C Virus Infection

Interventions

CTS-1027

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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