Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2007-12-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2.5 milligram (mg) CTS-1027
2.5 mg CTS-1027
CTS-1027
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
5 mg CTS-1027
5 mg CTS-1027
CTS-1027
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
10 mg CTS-1027
10 mg CTS-1027
CTS-1027
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
30 mg CTS-1027
30 mg CTS-1027
CTS-1027
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
Placebo
Placebo
Placebo
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd.
Interventions
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CTS-1027
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd (quaque die, once daily).
Placebo
Eligible patients were randomized to one of four doses of CTS-1027 (2.5 mg, 5 mg, 10 mg, or 30 mg) or placebo qd.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion 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
* 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:
1. drugs with presumed anti-HCV activity in the prior three months
2. corticosteroids in the past 30 days
3. 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
* 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.
18 Years
ALL
No
Sponsors
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FGK Clinical Research GmbH
INDUSTRY
Conatus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Conatus Pharmaceuticals Inc.
Principal Investigators
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William Frank, MD
Role: STUDY_DIRECTOR
Conatus Pharmaceuticals Inc.
Locations
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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
Countries
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Other Identifiers
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CTS-1027-01
Identifier Type: -
Identifier Source: org_study_id