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Sponsors and Collaborators: |
Conatus Pharmaceuticals Inc. FGK Clinical Research GmbH |
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Information provided by: | Conatus Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00570336 |
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 |
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Chronic Hepatitis C Virus Infection |
Drug: CTS-1027 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Dose Response Study of CTS-1027 in Hepatitis C Patients |
Estimated Enrollment: | 100 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
2.5 mg dose CTS-1027
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Drug: CTS-1027
2.5 mg CTS-1027 tablets once daily for 4 weeks, followed by 10 or 15 mg CTS-1027 tablets twice or three times daily for 20 weeks
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2: Experimental
5 mg CTS-1027
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Drug: CTS-1027
5 mg CTS-1027 tablets once daily for 4 weeks, followed by 10 or 15 mg CTS-1027 tablets twice or three times daily for 20 weeks
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3: Experimental
10 mg CTS-1027
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Drug: CTS-1027
10 mg CTS-1027 tablets once daily for 4 weeks, followed by 10 or 15 mg CTS-1027 tablets twice or three times daily for 20 weeks
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4: Experimental
30 mg CTS-1027
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Drug: CTS-1027
30 mg CTS-1027 tablets once daily for 4 weeks, followed by 10 or 15 mg CTS-1027 tablets twice or three times daily for 20 weeks
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Unsuccessful HCV treatment defined as one or more of the following criteria:
Exclusion Criteria:
Decompensated or severe liver disease defined by one or more of the following criteria:
Use of concomitant or prior drug therapy for HCV at screening, including the use of:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Scripps Clinic | |
La Jolla, California, United States, 92037 | |
California Pacific Medical Center | |
San Francisco, California, United States, 94115 | |
Kaiser Permanente | |
San Diego, California, United States, 92154 | |
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 | |
Mt. Sinai School of Medicine | |
New York, New York, United States, 10019 | |
Bronx VA Medical Center | |
Bronx, New York, United States, 10468 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
Consultants of Clinical Research | |
Cincinnati, Ohio, United States, 45219 | |
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 |
Study Director: | William Frank, MD | Conatus Pharmaceuticals Inc. |
Responsible Party: | Conatus Pharmaceuticals Inc. ( MiRa Huyghe ) |
Study ID Numbers: | CTS-1027-01 |
Study First Received: | December 6, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00570336 |
Health Authority: | United States: Food and Drug Administration |
HCV HCV treatment failure Elevated aminotransferases |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Flaviviridae Infections Infection |