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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01995071
Other study ID # M13-595
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2013
Est. completion date June 2015

Study information

Verified date July 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Chronic HCV infection prior to study enrollment. - Screening laboratory result indicating HCV genotype 1-infection. - Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening. - Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis. Exclusion Criteria: - History of severe, life-threatening or other significant sensitivity to any drug. - Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab). - Prior therapy for the treatment of HCV. - Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy. - Any cause of liver disease other than chronic HCV infection.

Study Design


Intervention

Drug:
ABT-493
Tablet
ABT-530
Tablet
ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin (RBV)
Tablet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

References & Publications (1)

Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1. Day 1 through prior to first dose of the combination regimen on Study Day 4
Secondary Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [ 12 weeks after last actual dose of combination study drug
Secondary Percentage of Participants With On-treatment Virologic Failure On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA = LLOQ at end of combination treatment with at least 6 weeks of combination treatment. Up to 87 days
Secondary Percentage of Participants With Post-treatment Relapse Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment. From the end of treatment through 12 weeks after the last dose of combination study drug
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