CTS-1027 in Interferon-Naive Hepatitis C Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: ribavirin; CTS-1027; Placebo for ribavirin
Intervention description: 200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks; 5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks; Capsules identical to ribavirin in appearance containing inactive ingredients
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; interferon-naive

Summary:

      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.
    

Eligibility criteria:

        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:

               -  Contra-indicated for interferon treatment due to current or prior psychiatric
                  disorders

               -  Patient's decision to not pursue interferon-based therapy

               -  In the opinion of the Principal Investigator, the patient is not a suitable
                  candidate for interferon-based therapy

          -  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:

                    1. Varices on esophagogastroduodenoscopy (EGD) with or without a history of
                       gastrointestinal bleeding; or

                    2. Ascites

          -  Cirrhosis defined by one or both of the following criteria:

               -  Liver biopsy showing cirrhosis

               -  Other clinical signs and symptoms suggestive of cirrhosis

          -  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.