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| Sponsor: | Conatus Pharmaceuticals Inc. |
|---|---|
| Information provided by: | Conatus Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00925990 |
Purpose
The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in HCV patients who have not previously been treated with interferon.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: ribavirin Drug: CTS-1027 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Trial of CTS-1027 in Interferon-Naive Hepatitis C Patients |
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CTS-1027 + ribavirin: Experimental
Study drug plus ribavirin
|
Drug: ribavirin
200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks
|
|
CTS-1027: Experimental
Study drug + placebo for ribavirin
|
Drug: CTS-1027
5 and 10 mg tablets, 15 mg BID, for up to 24 weeks
|
There are approximately 1 million HCV patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.
This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Unsuitable for interferon-based HCV treatment, defined as at least one of the following three criteria:
Exclusion Criteria:
Decompensated or severe liver disease defined by one or more of the following criteria:
Evidence of portal hypertension including:
Cirrhosis defined by one or both of the following criteria:
Contacts and Locations
Show 21 Study Locations| Study Chair: | Erin Castelloe, MD | Conatus Pharmaceuticals |
More Information
| Responsible Party: | Conatus Pharmacueticals ( Senior Director, Clinical Development ) |
| ClinicalTrials.gov Identifier: | NCT00925990 History of Changes |
| Other Study ID Numbers: | CTS-1027-03 |
| Study First Received: | June 19, 2009 |
| Last Updated: | August 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
HCV interferon-naive |
|
Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Interferons |
Ribavirin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |