Last updated on December 2016

A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatitis C
  • Age: Between 18 - 65 Years
  • Gender: Male or Female
  • Other:
    Main Inclusion Criteria:
    Male or female aged ≥ 18 to ≤ 65 years;
    Body mass index ≥ 18.5 to ≤ 35.0 kg/m2;
    Body weight ≥ 50 kg;
    Negative screening for alcohol and drugs of abuse;
    Normal results on 12-lead electrocardiogram (ECG);
    For females, negative result on a pregnancy test.
    HCV treatment-naïve subjects must have not received prior direct acting agent (DAA)
    treatment for hepatitis C infection;
    Documented clinical history compatible with chronic hepatitis C;
    HCV Genotype 1 by HCV genotyping performed at Screening;
    Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening;
    Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest,
    F2 or lower) within one year prior to study), if these are not available, do a
    FibroTest at screening, which must be F2 or lower.
    Main Exclusion Criteria:
    Females who are pregnant or are lactating;
    Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human
    immunodeficiency virus (HIV);
    Abuse of alcohol and/or drugs that could interfere with adherence to study
    requirements as judged by the investigator;
    Positive screen result for drugs of abuse or alcohol on Day -1. Use of other
    investigational drugs within 60 days of dosing;
    Subject with intestinal malabsorption;
    Presence of out-of-range cardiac interval on the screening ECG or other clinically
    ignificant ECG abnormalities;
    Serum creatinine > upper limit of normal (ULN);
    Any clinically significant medical condition that, in the opinion of the
    investigator, would jeopardize the safety of the subject or impact the validity of
    the study results.
    Positive screen for anti-HCV antibody
    Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis;
    History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic
    encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal
    hypertension or hepatic insufficiency;
    History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;
    Active clinically significant diseases.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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