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Status:

COMPLETED

CTS-1027 in Interferon-Naive Hepatitis C Patients

Lead Sponsor:

Conatus Pharmaceuticals Inc.

Conditions:

Hepatitis C

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.

Detailed Description

There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects o...

Eligibility Criteria

Inclusion

  • 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 (\> 6 months duration) genotype 1 Hepatitis C (HCV) infection
  • Unsuitable for interferon-based HCV treatment, defined as at least one of the following three criteria:
  • Contra-indicated for interferon treatment due to current or prior psychiatric disorders
  • Patient's decision to not pursue interferon-based therapy
  • In the opinion of the Principal Investigator, the patient is not a suitable candidate for interferon-based therapy
  • a-fetoprotein (AFP) \<= 50 ng/mL
  • Hemoglobin ≥ 12 g/dL, platelet count ≥ 100 x 109/L, and white blood cell count ≥ 1.5 x 109/L
  • Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the trial.

Exclusion

  • Decompensated or severe liver disease defined by one or more of the following criteria:
  • Prothrombin time 3 seconds \> control
  • Direct bilirubin ≥ 1.5 x upper limit of normal range (ULN)
  • Serum albumin below normal limits
  • AST or ALT \> 7 x ULN at screening
  • Evidence of portal hypertension including:
  • Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
  • Ascites
  • Cirrhosis defined by one or both of the following criteria:
  • Liver biopsy showing cirrhosis
  • Other clinical signs and symptoms suggestive of cirrhosis
  • Prior therapy for HCV with an interferon-based regimen
  • Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
  • Known history or presence of human immunodeficiency virus (HIV) infection
  • Co-infection with hepatitis B virus (HBV)
  • If female: pregnant, lactating, or positive serum pregnancy test
  • Renal impairment (creatinine \> 1.5 x ULN), creatinine clearance \< 50 mL/min, or hepatorenal syndrome
  • Hospitalization for liver disease within 60 days of screening
  • Use of concomitant or prior drug therapy for HCV three months prior to screening
  • Use of drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
  • History of alcohol abuse (\> 50 g per day) within the past year
  • History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or QTc interval of \> 450 milliseconds
  • Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years
  • Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial.

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2010

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT00925990

Start Date

June 1 2009

End Date

July 1 2010

Last Update

March 27 2012

Active Locations (21)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (21 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Medical Associates Research Group

San Diego, California, United States, 92123

3

Kaiser Permanante

San Diego, California, United States, 92154

4

VA Medical Center, San Diego

San Diego, California, United States, 92161