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Study of CTS-1027 in Hepatitis C Patients

This study has been completed.
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by:
Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00570336
First received: December 6, 2007
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C Virus Infection
Drug: CTS-1027
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Response Study of CTS-1027 in Hepatitis C Patients

Resource links provided by NLM:


Further study details as provided by Conatus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Number of adverse events at each dose level [ Time Frame: 4 to 24 weeks ] [ Designated as safety issue: Yes ]
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) levels at each dose [ Time Frame: 4-24 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Peak and trough levels of CTS-1027 in plasma [ Time Frame: 4 to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: December 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2.5 milligram (mg) CTS-1027
2.5 mg CTS-1027
Drug: 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).
Experimental: 5 mg CTS-1027
5 mg CTS-1027
Drug: 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).
Experimental: 10 mg CTS-1027
10 mg CTS-1027
Drug: 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).
Experimental: 30 mg CTS-1027
30 mg CTS-1027
Drug: 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 Comparator: Placebo
Placebo
Other: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570336

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Kaiser Permanente
San Diego, California, United States, 92154
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Mt. Sinai School of Medicine
New York, New York, United States, 10019
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Consultants of Clinical Research
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Advanced Liver Therapies - Baylor College of Medicine
Houston, Texas, United States, 77030
VAMC - Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
McGuire Hospital DVAMC
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
FGK Clinical Research GmbH
Investigators
Study Director: William Frank, MD Conatus Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: MiRa Huyghe, Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00570336     History of Changes
Other Study ID Numbers: CTS-1027-01
Study First Received: December 6, 2007
Last Updated: September 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Conatus Pharmaceuticals Inc.:
HCV
HCV treatment failure
Elevated aminotransferases

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Virus Diseases
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on November 20, 2014