Status and phase
Conditions
Treatments
About
The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.
Full description
There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.
This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.
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 (> 6 months duration) genotype 1 Hepatitis C (HCV) infection
Unsuitable for interferon-based HCV treatment, defined as at least one of the following three criteria:
a-fetoprotein (AFP) <= 50 ng/mL
Hemoglobin ≥ 12 g/dL, platelet count ≥ 100 x 109/L, and white blood cell count ≥ 1.5 x 109/L
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.
Exclusion criteria
Decompensated or severe liver disease defined by one or more of the following criteria:
Prothrombin time 3 seconds > control
Direct bilirubin ≥ 1.5 x upper limit of normal range (ULN)
Serum albumin below normal limits
AST or ALT > 7 x ULN at screening
Evidence of portal hypertension including:
Cirrhosis defined by one or both of the following criteria:
Prior therapy for HCV with an interferon-based regimen
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 pregnancy test
Renal impairment (creatinine > 1.5 x ULN), creatinine clearance < 50 mL/min, or hepatorenal syndrome
Hospitalization for liver disease within 60 days of screening
Use of concomitant or prior drug therapy for HCV three months prior to screening
Use of drugs of abuse in the prior three months (allowed if medically prescribed or indicated)
History of alcohol abuse (> 50 g per day) 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
70 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal