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| Sponsor: | Conatus Pharmaceuticals Inc. |
|---|---|
| Information provided by (Responsible Party): | 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 |
Drug: CTS-1027 Drug: Pegylated interferon Drug: Ribavirin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Enrollment: | 67 |
| Study Start Date: | January 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CTS-1027, Peg IFN, Ribavirin
Study drug (CTS-1027) plus Standard of Care treatment (pegylated interferon and ribavirin). CTS-1027, 15 mg taken twice daily. Pegylated interferon, 180 μg injected once a week. Ribavirin, 1000 mg or 1200 mg daily (depending on patient weight), taken in two divided doses. |
Drug: CTS-1027
CTS-1027 supplied in 5 and 10 mg tablets, 15 mg taken twice daily, for up to 48 weeks
Drug: Pegylated interferon
Pegylated interferon, 180 micrograms in 0.5 ml of solution injected subcutaneously (SQ) once per week, for up to 48 weeks. Packaged in single use syringes.
Other Name: Pegasys
Drug: Ribavirin
Ribavirin, 200 mg capsules taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg for up to 48 weeks.
Other Name: Copegus
|
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 both phases 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:
Evidence of portal hypertension including:
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 Inc. |
| ClinicalTrials.gov Identifier: | NCT01051921 History of Changes |
| Other Study ID Numbers: | CTS-1027-04 |
| Study First Received: | January 18, 2010 |
| Results First Received: | March 13, 2012 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
HCV Null Responder |
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Interferons Ribavirin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |