Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01051921

Run by

Conatus Pharmaceuticals Inc.

People needed

67

Starts

2010-01-01

Expected to finish

2011-12-01

Last updated by the study team

2012-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the trial
• HCV genotype 1 infected null responders to prior therapy comprised of pegylated interferon and ribavirin (standard of care, SOC) defined as:
• Failure to achieve an early virologic response (< 2 log decline in HCV-RNA by Week 12), or
• If Week 12 HCV-RNA was not obtained but Week 24 was obtained, Week 24 response was < 2 log decline
• Alpha-fetoprotein (AFP) <= 50 ng/mL
• Hemoglobin ≥ 12 g/dL, platelet count ≥ 125 x 10\^9/L, and white blood cell count ≥ 1.5 x 10\^9/L
• In the opinion of the Principal Investigator, the patient met the 80%/80%/80% rule during the previous pegylated interferon and ribavirin therapy (i.e., received at least 80% of the pegylated interferon and ribavirin doses, at least 80% of the dose size, for at least 80% of the treatment duration)
• Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to at least six months after the completion of the trial.

You may not qualify if…

• < 2 log decline in HCV-RNA at Week 12 but > 2 log decline at any time from Week 12 to Week 24 during prior therapy with pegylated interferon and ribavirin (prior standard of care therapy)
• Decompensated or severe liver disease defined by one or more of the following criteria:
• Prothrombin time 3 seconds > control
• Direct bilirubin ≥ 1.5 x ULN
• Serum albumin below normal limits
• AST or ALT > 7 x ULN at screening
• Evidence of portal hypertension including:
• Varices on esophagogastroduodenoscopy (EGD) with or without a history of gastrointestinal bleeding; or
• Ascites
• Cirrhosis defined by one or both of the following criteria:
• Liver biopsy showing cirrhosis
• Other clinical signs and symptoms suggestive of cirrhosis
• Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
• Clinically significant ocular findings such as retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or other abnormality
• Known history or presence of human immunodeficiency virus (HIV) infection
• Co-infection with hepatitis B virus (HBV)
• If female: pregnant, lactating, or positive serum or urine pregnancy test
• Male partners of women who are currently pregnant
• Renal impairment (creatinine > 1.5 x ULN), creatinine clearance < 50 mL/min, or hepatorenal syndrome with ascites
• Hospitalization for liver disease within 60 days of screening
• History of alcohol abuse (> 50 g per day) within the past year
• History of severe psychiatric disease, especially depression, characterized by:
• Suicide attempt
• Hospitalization for psychiatric disease
• Period of disability as a result of psychiatric disease

Where it is running

• Scripps Clinic — La Jolla, California, United States
• VA Medical Center, San Diego — San Diego, California, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Henry Ford Medical Center-Columbus — Novi, Michigan, United States
• MN Clinical Research Center — Plymouth, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Consultants of Clinical Research, Ohio GI and Liver Institute — Cincinnati, Ohio, United States
• Advanced Liver Therapies - Baylor College of Medicine — Houston, Texas, United States
• VA Medical Center, Houston — Houston, Texas, United States
• University of Utah Health Science Center — Salt Lake City, Utah, United States
• Liver Institute of Virginia — Newport News, Virginia, United States
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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