Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders (CTS-1027-04)
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.
Drug: Pegylated interferon
|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|
- Early Virologic Response (EVR) [ Time Frame: Baseline and Study week 12 ] [ Designated as safety issue: No ]Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment.
- > 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks [ Time Frame: Baseline and Study week 24 ] [ Designated as safety issue: No ]Percent of patients experiencing a drop in HCV-RNA Hepatitis C virus ribonucleic acid, also known as "viral load") levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 24 weeks of treatment.
|Study Start Date:||January 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
CTS-1027 supplied in 5 and 10 mg tablets, 15 mg taken twice daily, for up to 48 weeksDrug: 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: PegasysDrug: 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.
|United States, California|
|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|
|Fundacion de Investigacion de Diego|
|Santurce, Puerto Rico, 00909|
|Study Chair:||Erin Castelloe, MD||Conatus Pharmaceuticals|