Clinical trial NCT01265511 (phase 2, status: completed)
Conditions: hepatitis c infection
ICD codes: B17.0
Drugs: placebo, scy-635, pegasys, copegus
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)(C)O)N(C)C(=O)[C@@H](SCCN(C)C)N(C)C1=O)C(C)C, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  Quantifiable serum levels of HCV-specific RNA in excess of 100,000 IU/mL

          -  Chronic HCV status

          -  HCV genotype 1 infection and IL28B genotype of C/T or T/T

          -  Liver biopsy results within 3 years prior to screening indicating the absence of
             cirrhosis

             *If no previous biopsy is available, a biopsy must be performed during the screening
             period to qualify for randomization

          -  Body mass index (BMI) between 18 and 38 kg/m2

          -  Laboratory variables within acceptable ranges:

               -  ALT/AST < 3 × ULN;

               -  HgB > 12g/dL for females, > 13 g/dL for males;

               -  total WBC count > 3000/mm3 and ANC > 1500/mm3;

               -  platelets > 100,000/mm3;

               -  prothrombin time (or INR) ≤ 1.2 × ULN;

               -  serum albumin ≥ 3.4 g/dL;

               -  total bilirubin WNL;

               -  serum creatinine WNL; if serum creatinine is > ULN, then calculated creatinine
                  clearance must be > 100 mL/min (by Cockcroft-Gault formula) for subject to be
                  eligible

          -  Subjects of childbearing potential (i.e., not surgically sterile or postmenopausal)
             must agree to use 2 forms of contraception from Screening until 24 weeks after
             completion of treatment with RBV

          -  Negative urine testing for amphetamines and cocaine at Screening.

          -  If female, the subject has a negative pregnancy test at Screening and on study Day 1

        Exclusion Criteria:

          -  History of clinically significant gastrointestinal, renal, hepatic, neurologic,
             hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or
             cardiovascular disease

          -  Females who are pregnant or breastfeeding

          -  Males with partners who are pregnant or are planning to become pregnant

          -  HCV genotype other than genotype 1 and an IL28B genotype of C/C

          -  Seropositive for HIV-1 or HIV-2 or hepatitis B virus (HBV) surface antigen (HBsAg)

          -  Use of any investigational agent within 3 months prior to dosing

          -  Received any prior FDA-approved or investigational drug or drug regimen for the
             treatment of hepatitis C

          -  Evidence of cirrhosis on a previous liver biopsy

          -  Evidence of decompensated liver disease

          -  Recipient of an organ transplant

          -  Evidence of hepatocellular carcinoma

          -  Evidence of ongoing alcohol or substance abuse

          -  Poorly-controlled diabetes mellitus

          -  Congestive heart failure or unstable cardiopulmonary condition, renal disease, or
             hemoglobinopathy (sickle cell anemia or thalassemia

          -  History of seizure disorder

          -  History of severe psychiatric illness, including severe depression, history of
             suicidal ideation, suicidal attempts, related hospitalizations, bipolar disorder, or
             psychosis requiring medication

          -  Concurrent medical condition or laboratory abnormality that would constitute a
             contra-indication for interferon use

          -  History of unstable thyroid disease that would preclude administration of
             interferon-based therapy

          -  Medical condition that requires use of systemic corticosteroids

          -  Received warfarin or other anticoagulants during the 21 days immediately prior to
             Screening, or is expected to require warfarin or other anticoagulants during the
             study.

          -  One or more additional known primary or secondary causes of liver disease, other than
             hepatitis C

          -  Any other concurrent medical condition likely to preclude compliance with the schedule
             of evaluations, or likely to confound the efficacy or safety observations

          -  12-lead ECG showing the following:

               -  Corrected QTc interval ≥ 450 msec (Bazett's correction);

               -  QRS > 120 msec;

               -  Clinically significant abnormalities;

          -  Severe retinopathy or other significant ophthalmological disorder

          -  Use of any herbal supplements within 28 days prior to dosing.

          -  The use of CYP3A inducers or inhibitors for at least 2 weeks prior to initiation of
             treatment through Week 6