Status and phase
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About
The purpose of this study is to determine if CTS-1027 can lower elevated liver enzymes in patients with chronic HCV infection.
Full description
Randomized, placebo-controlled, double-blind, parallel group, multicenter, dose response trial utilizing four doses of CTS-1027, administered orally once daily, in outpatients with chronic hepatitis C virus (HCV) infection.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
A history of chronic HCV infection
Unsuccessful HCV treatment defined as one or more of the following criteria:
Liver impairment, as defined by either aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels 1.5 - 7 x ULN on at least two occasions, seven or more days apart, during the baseline period
Alpha-fetoprotein (AFP) <= 50 ng/mL
Hemoglobin >= 10 g/dL, platelet count >= 75 x 109/L, and white blood cell count >= 1.5 x 109/L
Willingness to utilize adequate contraception (if female, evidenced by being postmenopausal for at least 6 months or using contraceptive pill; for both females and males, being surgically sterile, or using two forms of barrier contraception) from screening to at least one month after the completion of the trial.
Exclusion criteria
Decompensated or severe liver disease defined by one or more of the following criteria:
Splenomegaly or evidence of portal hypertension (i.e., enlarged portal vein and varices) on ultrasound,
Varices in esophagogastroduodenoscopy (EGD); or
Ascites
Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or other imaging techniques)
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
Last baseline AST and ALT level prior to Day 1 of < 1.5 x ULN
Renal impairment (creatinine > 1.5 x ULN) or hepatorenal syndrome
Pancreatitis
Hospitalization for liver disease within 60 days of screening
Use of concomitant or prior drug therapy for HCV at screening, including the use of:
Use of illicit or drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
History of alcohol abuse within the past year
History or presence of clinically concerning cardiac arrhythmias or prolongation of pre-dose QT or QTc interval of > 450 milliseconds
Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure) or any malignancy other than curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for ten or more years
Any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial.
Primary purpose
Allocation
Interventional model
Masking
87 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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