Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects

Study Identifier
M13-386
CT.gov Identifier
NCT01563536
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • ABT-267
  • ABT-450
  • ABT-333
  • Ritonavir
  • Ribavirin
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female between the age of 18 and 70 years, inclusive, at time of enrollment. * Subject has never received antiviral treatment for hepatitis C virus (HCV) infection. * Body mass index (BMI) is ≥ 18 to \< 38 kg/m\^2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m). * Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment. * Subject has plasma HCV RNA level \> 10,000 IU/mL at screening
    Exclusion Criteria:
    * History of severe, life-threatening or other significant sensitivity to any drug. * Females who are or plan to become pregnant or breastfeeding or males whose partner is pregnant or planning to become pregnant. * Recent history of drug or alcohol abuse that could preclude adherence to the protocol. * Positive test result for hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibodies. * Any current or past clinical evidence of cirrhosis (e.g., ascites, esophageal varices), or a liver biopsy or FibroTest/aspartate aminotransferase to platelet ratio (APRI) or FibroScan® showing cirrhosis or extensive bridging fibrosis.

    Protocol Summary

    The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and antiviral activity of multiple, ascending doses of ABT-267 (also known as ombitasvir) administered as two-day monotherapy followed by ABT-267 in combination therapy with other direct-acting antiviral agents (DAAs) ABT-450 with ritonavir (ABT-450/r) and ABT-333 (also known as dasabuvir) plus ribavirin (RBV) in patients with chronic Hepatitis C virus (HCV) infection without cirrhosis.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 68002
    Bakersfield, California, United States, 93301
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 67383
    Orlando, Florida, United States, 32809
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 67382
    Annapolis, Maryland, United States, 21401
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 67385
    Poughkeepsie, New York, United States, 12601
    Status
    Not applicable