Clinical trial NCT02115321 (phase 2/phase 3, status: completed)
Conditions: chronic hepatitis c
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4
Drugs: grazoprevir, elbasvir, mk-5172a
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, 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 HCV GT1 infection (for Arm 4 participants may have GT4 or GT6
             infection) with no evidence of non-typable or mixed genotype infection

          -  Has clinical evidence of hepatic cirrhosis with a score on the Child-Pugh scale from 7
             to 9 and not anticipated to receive a liver transplant within the next 36 weeks (for
             Arm 1, Arm 3, and Arm 4)

          -  Has no evidence of cirrhosis (only for Arm 2 )

          -  Agrees to remain truly abstinent or use (or have their partner use) an acceptable
             method of birth control from at least 2 weeks prior to Day 1 and continue until at
             least 14 days after last dose of study drug, or longer if dictated by local
             regulations

        Exclusion criteria:

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

          -  Has previously received direct-acting antiviral therapy for HCV

          -  Has a history of malignancy <=5 years prior to signing informed consent except for
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
             or carcinoma in situ; or under evaluation for other active or suspected malignancy

          -  Has cirrhosis and liver imaging results within 4 weeks prior to screening showing
             evidence of hepatocellular carcinoma (HCC), or is under evaluation for HCC

          -  Is currently participating or has participated in a study with an investigational
             compound within 30 days of signing informed consent and is not willing to refrain from
             participating in another such study during the course of this study

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

          -  Is pregnant or breast-feeding, or expecting to conceive or donate eggs or sperm from
             at least 2 weeks prior to Day 1 and continue throughout treatment and follow up, or
             longer if dictated by local regulations

          -  Has received organ transplants (including hematopoietic stem cell transplants) other
             than cornea and hair

          -  Has poor venous access

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

          -  Requires, or likely to require, chronic systemic administration of corticosteroids
             during the course of the trial

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