CTS-1027 in Interferon-Naive Hepatitis C Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00925990

Run by

Conatus Pharmaceuticals Inc.

People needed

70

Starts

2009-06-01

Expected to finish

2010-07-01

Last updated by the study team

2012-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Medical Associates Research Group — San Diego, California, United States
• Kaiser Permanante — San Diego, California, United States
• VA Medical Center, San Diego — San Diego, California, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainsville, Florida, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of MA Mem Med Ctr — Worchester, Massachusetts, United States
• Henry Ford Medical Center-Columbus — Novi, Michigan, United States
• MN Clinical Research Center — Plymouth, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of NC at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States
• Consultants of Clinical Research, Ohio GI and Liver Institute — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• VA Medical Center, Houston — Houston, Texas, United States
• VCU-Medical College of Virginia — Richmond, Virginia, United States
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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