Study of CTS-1027 in Hepatitis C Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C Virus Infection

In brief

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

Key facts

Study ID

NCT00570336

Run by

Conatus Pharmaceuticals Inc.

People needed

87

Starts

2007-12-01

Expected to finish

2009-07-01

Last updated by the study team

2010-09-16

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 HCV infection
• Unsuccessful HCV treatment defined as one or more of the following criteria:
• Failure to achieve a virologic response during previous therapy, or
• Failure to tolerate therapy, or
• Failure to maintain a sustained virologic response, or
• 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
• Willingness to utilize adequate contraception (if female, evidenced by being postmenopausal for at least 6 months or using contraceptive pill; for both females and males, being surgically sterile, or using two forms of barrier contraception) from screening to at least one month 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:
• Prior liver biopsy showing cirrhosis
• Prior liver biopsy showing bridging fibrosis (Metavir >2 or Ishak >3) more than 2 years ago in the absence of newer liver biopsy results
• Prothrombin time: 3 seconds > control
• Total bilirubin >= 1.5 x Upper limit of the normal range (ULN), or > 3 x ULN for unconjugated bilirubin
• Serum albumin below normal limits
• AST or ALT > 7 x ULN during baseline period
• 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
• Ascites
• 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 or urine pregnancy test
• Last baseline AST and ALT level prior to Day 1 of < 1.5 x ULN
• Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome
• Pancreatitis
• Hospitalization for liver disease within 60 days of screening
• Use of concomitant or prior drug therapy for HCV at screening, including the use of:
• drugs with presumed anti-HCV activity in the prior three months
• corticosteroids in the past 30 days
• potentially hepatotoxic drugs in the past 30 days (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
• Use of illicit or drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
• History of alcohol abuse within the past year

Where it is running

• 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
• Mayo Clinic — Rochester, Minnesota, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Bronx VA Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Consultants of Clinical Research — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Advanced Liver Therapies - Baylor College of Medicine — Houston, Texas, United States
• VAMC - Baylor College of Medicine — Houston, Texas, United States
• McGuire Hospital DVAMC — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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