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| Sponsor: | Conatus Pharmaceuticals Inc. |
|---|---|
| Information provided by: | Conatus Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT01051921 |
Purpose
The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated interferon and ribavirin can improve the response rates in HCV patients who did not previously respond to pegylated interferon and ribavirin therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus Infection |
Drug: CTS-1027, Pegylated Interferon, Ribavirin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Control: Historical Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Trial of Pegylated Interferon Plus Ribavirin in Combination With CTS-1027 in HCV Null-Responders |
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| CTS-1027, Peg IFN, Ribavirin: Experimental |
Drug: CTS-1027, Pegylated Interferon, Ribavirin
CTS-1027 15 mg BID, Pegylated interferon 180 mcg/week, Ribavirin 1000 or 1200 mg/day for at least 24 weeks
|
A subset of non-responders to standard of care treatments (pegylated interferon and ribavrin) is termed null responders. Null responders are the most treatment refractory population. Treatment for null responders is currently limited: retreatment with SOC results in approximately 5% sustained virologic response (SVR).
CTS-1027 may facilitate the activity of interferon by preventing MMP-induced cleavage and deactivation in the first phase of clinical response to therapy. In addition, CTS-1027, like ribavirin, alone does not significantly affect viral replication, but both CTS-1027 and ribavirin are likely to impact response to therapy during the second and slower phase of the clinical response.
The potential of MMP inhibition to facilitate the action of interferon, together with ribavirin-driven up-regulation of interferon stimulated genes, has the potential to yield a potent host immune response in this highly resistant null-responder patient population. Again, since MMP inhibition is thought to target the second slower phase kinetics, the initial treatment duration in this trial will be 24 weeks.
This trial will evaluate the safety and efficacy of CTS-1027 combined with SOC in patients who did not previously respond to SOC therapy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:
Exclusion Criteria:
Decompensated or severe liver disease defined by one or more of the following criteria:
Cirrhosis defined by one or both of the following criteria:
History of severe psychiatric disease, especially depression, characterized by:
Contacts and Locations| United States, California | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| VA Medical Center, San Diego | |
| San Diego, California, United States, 92161 | |
| United States, Colorado | |
| University of Colorado Health Science Center | |
| Denver, Colorado, United States, 80262 | |
| South Denver Gastroenterology | |
| Englewood, Colorado, United States, 80113 | |
| 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, Michigan | |
| Henry Ford Medical Center-Columbus | |
| Novi, Michigan, United States, 48377 | |
| United States, Minnesota | |
| MN Clinical Research Center | |
| Plymouth, Minnesota, United States, 55446 | |
| United States, Missouri | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Ohio | |
| Consultants of Clinical Research, Ohio GI and Liver Institute | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Texas | |
| Advanced Liver Therapies - Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| VA Medical Center, Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Health Science Center | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Liver Institute of Virginia | |
| Newport News, Virginia, United States, 23602 | |
| Puerto Rico | |
| Fundacion de Investigacion de Diego | |
| Santurce, Puerto Rico, 00909 | |
| Study Chair: | Erin Castelloe, MD | Conatus Pharmaceuticals |
More Information
| Responsible Party: | Conatus Pharmaceuticals ( Anthony Fox, MD, PhD ) |
| ClinicalTrials.gov Identifier: | NCT01051921 History of Changes |
| Other Study ID Numbers: | CTS-1027-04 |
| Study First Received: | January 18, 2010 |
| Last Updated: | August 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
HCV Null Responder |
|
Hepatitis Hepatitis C Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Flaviviridae Infections RNA Virus Infections Interferons |
Ribavirin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |