Clinical trial NCT01273064 (phase 2, status: terminated)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: cts-1027, pegylated interferon, ribavirin, placebo
SMILES: ONC(=O)C1(CS(=O)(=O)C2=CC=C(OC3=CC=C(Cl)C=C3)C=C2)CCOCC1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    risk-benefit ratio
  
Eligibility criteria:

        Inclusion Criteria:

          1. 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

          2. 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

          3. Screening HCV-RNA viral load of > 5.0 log (i.e., >100,000 IU/mL)

          4. alpha-fetoprotein (AFP) less than or equal to 100 ng/mL

          5. 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

          6. Thyroid Stimulating Hormone (TSH) within normal limits

          7. 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)

          8. 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.

        Exclusion Criteria:

          1. < 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)

          2. 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

          3. Hepatic encephalopathy

          4. Hepatocellular carcinoma (HCC) or suspicion of HCC clinically or on ultrasound (or
             other imaging techniques)

          5. Clinically significant ocular findings such as retinopathy, cotton wool spots, optic
             nerve disorder, retinal hemorrhage, or other abnormality

          6. Known history or presence of human immunodeficiency virus (HIV) infection

          7. Co-infection with hepatitis B virus (HBV)

          8. If female: pregnant, lactating, or positive serum or urine pregnancy test

          9. Male partners of women who are currently pregnant

         10. Renal impairment (creatinine > 1.2 x ULN), serum creatinine clearance < 50 mL/min, or
             hepatorenal syndrome with ascites

         11. Hospitalization for liver disease within 60 days of screening

         12. History of alcohol abuse (> 50 g per day) within the past year

         13. History of severe psychiatric disease, especially depression, characterized by:

               -  Suicide attempt

               -  Hospitalization for psychiatric disease

               -  Period of disability as a result of psychiatric disease

         14. Prior exposure to CTS-1027

         15. Patients who qualify as a null-responder based on treatment(s) other than pegylated
             interferon and ribavirin

         16. History or presence of clinically concerning cardiac arrhythmias or prolongation of
             pre-dose corrected Q-T interval (QTc) of > 450 milliseconds

         17. History of or current autoimmune disease

         18. Diagnosis of or symptoms suggestive of fibromyalgia

         19. Currently on liver transplantation waiting list or recipient of any organ transplant

         20. 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 five or more years

         21. Exposure to any other investigational treatment for any aspect of disease associated
             with HCV during the past 6 months

         22. Exposure to any investigational drug or device within 30 days of dosing, or scheduled
             receipt of another investigational drug or device during the course of this study.