Clinical trial NCT02203149 (phase 2/phase 3, status: completed)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: grazoprevir, elbasvir, placebo to grazoprevir, placebo to elbasvir
SMILES: [H][C@@]12C[C@@]1([H])OC(O)=N[C@]([H])(C(=O)N1C[C@@]([H])(C[C@@]1([H])C(O)=N[C@@]1(C[C@@]1([H])C=C)C(O)=NS(=O)(=O)C1CC1)OC1=C(CCCCC2)N=C2C=CC(OC)=CC2=N1)C(C)(C)C, COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC(=CN1)C1=CC2=C(C=C1)N1[C@@H](OC3=C(C=CC(=C3)C3=CNC(=N3)[C@@H]3CCCN3C(=O)[C@@H](NC(=O)OC)C(C)C)C1=C2)C1=CC=CC=C1, [H][C@@]12C[C@@]1([H])OC(O)=N[C@]([H])(C(=O)N1C[C@@]([H])(C[C@@]1([H])C(O)=N[C@@]1(C[C@@]1([H])C=C)C(O)=NS(=O)(=O)C1CC1)OC1=C(CCCCC2)N=C2C=CC(OC)=CC2=N1)C(C)(C)C, COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC(=CN1)C1=CC2=C(C=C1)N1[C@@H](OC3=C(C=CC(=C3)C3=CNC(=N3)[C@@H]3CCCN3C(=O)[C@@H](NC(=O)OC)C(C)C)C1=C2)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Has documented chronic Japanese HCV genotype (GT) 1 with no evidence of non-typeable
             or mixed GT infection

          -  Is treatment-naïve, or intolerant or non-responder to prior anti-HCV interferon
             (IFN)-based treatment without direct acting antiviral (DAA) therapy, prior IFN-based
             treatment with DAA therapy, or prior DAA therapy

          -  Agrees to the use of contraception if a female of reproductive potential

        Exclusion Criteria:

          -  Has evidence of decompensated liver disease manifested by the presence of or history
             of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other
             signs or symptoms of advanced liver disease

          -  Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)

          -  Has a history of malignancy ≤5 years prior to signing informed consent except for
             adequately treated basal cell or squamous cell skin cancer or carcinoma in situ

          -  Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of
             hepatocellular carcinoma (HCC) or is under evaluation for HCC (Part 2 only)

          -  Has clinically-relevant drug or alcohol abuse within 12 months of screening

          -  Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs
             from Day 1 and continue throughout treatment and follow-up (or longer if dictated by
             local regulations)

          -  Has any of the following conditions:

          -  Organ transplants (including hematopoietic stem cell transplants) other than cornea
             and hair

          -  Poor venous access

          -  History of gastric surgery (e.g., stapling, bypass) or subject with a history of
             malabsorption disorders (e.g., celiac sprue disease)

          -  History of a medical/surgical condition that resulted in hospitalization within the 3
             months prior to enrollment, other than for minor elective procedures

          -  Medical/surgical conditions that may result in a need for hospitalization during the
             period of the study

          -  Any medical condition requiring, or likely to require, chronic systemic administration
             of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the
             course of the trial

          -  Has chronic hepatitis not caused by HCV, including but not limited to nonalcoholic
             steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis