Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

Placebo controlled, double-blind, multicenter study utilizing standard of care (SOC) treatment (ribavirin plus pegylated interferon) in combination with CTS-1027 in genotype 1 chronic Hepatitis C (HCV) patients who were null-responders to previous SOC therapy(ies). Null-responders are defined as patients who failed to achieve a greater than 2 log drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as "viral load") levels after 12 weeks of treatment (know as an "early virologic response", or EVR) during previous SOC therapy. If, during previous SOC treatment, a patient had a less than 2 log decline in HCV-RNA at Week 12 but greater than 2 log decline in HCV-RNA at any time from Week 12 to Week 24, that patient is not a null-responder, and is excluded from study participation. If, during previous SOC treatment, a Week 12 HCV-RNA was not obtained, the post Week 12 response must have been \< 2 log decline (and still HCV-RNA positive) in order for the patient to be defined as a null-responder. Patients will be screened and have up to 4 weeks to qualify for study entry. During this screening period, clinical and laboratory tests will be performed. At Week 0/Day 1, patients will undergo centralized, stratified (based on ethnicity), randomization to one of four treatment arms: SOC + one of three doses of CTS-1027 or SOC + placebo. Study treatment will last 24, 48, or 60 weeks, based on each patient's response to study treatment. SOC + placebo patients who do not show a virologic response after 12 weeks of therapy will be rolled onto SOC + 15mg CTS-1027, while maintaining the study blind.

Key facts

Study ID

NCT01273064

Run by

Conatus Pharmaceuticals Inc.

People needed

114

Starts

2011-01-01

Expected to finish

2011-10-01

Last updated by the study team

2012-06-11

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 study
• 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, post Week 12 HCV-RNA response was < 2 log decline
• Screening HCV-RNA viral load of > 5.0 log (i.e., >100,000 IU/mL)
• alpha-fetoprotein (AFP) less than or equal to 100 ng/mL
• Hemoglobin greater than or equal to 12 g/dL for women and greater than or equal to 13 g/dL for men, hemoglobin A1c less than or equal to 7.5 %, platelet count greater than or equal to 90 x 10\^9/L, and white blood cell count greater than or equal to 1.5 x 10\^9/L
• Thyroid Stimulating Hormone (TSH) within normal limits
• 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 study.

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 4 seconds > control or INR (international normalized ratio) > 1.2
• Total bilirubin ≥ 1.5 mg/dL or direct bilirubin ≥ 1 mg/dL
• Serum albumin below normal limits
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5 x upper limit of normal (ULN) at screening
• Presence of ascites
• Hepatic encephalopathy
• 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 > 1.2 x ULN), serum 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
• Prior exposure to CTS-1027
• Patients who qualify as a null-responder based on treatment(s) other than pegylated interferon and ribavirin
• History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose corrected Q-T interval (QTc) of > 450 milliseconds
• History of or current autoimmune disease

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Southern California Liver Centers — Coronado, California, United States
• Scripps Clinic — La Jolla, California, United States
• Loma Linda University MC — Loma Linda, California, United States
• Huntington Medical Research Institute — Pasadena, California, United States
• Medical Associates Research Group — San Diego, California, United States
• UCSD — San Diego, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Atlanta Medical Center, Inc. — Atlanta, Georgia, United States
• Liver Center of Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Loyola University — Maywood, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Louis University — St Louis, Missouri, United States
• Concorde Medical Group — New York, New York, United States

Full record on ClinicalTrials.gov

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