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| Sponsor: | Conatus Pharmaceuticals Inc. |
|---|---|
| Collaborator: |
FGK Clinical Research GmbH |
| Information provided by: | Conatus Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00570336 |
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 |
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 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
2.5 mg dose CTS-1027
|
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
|
|
2: Experimental
5 mg CTS-1027
|
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
|
|
3: Experimental
10 mg CTS-1027
|
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
|
|
4: Experimental
30 mg CTS-1027
|
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
|
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 |
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:
Contacts and 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 | |
| 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. |
More Information
| Responsible Party: | Conatus Pharmaceuticals Inc. ( MiRa Huyghe ) |
| Study ID Numbers: | CTS-1027-01 |
| Study First Received: | December 6, 2007 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00570336 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HCV HCV treatment failure Elevated aminotransferases |
|
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases Flaviviridae Infections |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Infection Hepatitis C, Chronic |