Chronic Hepatitis C Clinical Trial
Official title:
A Randomized, Open-Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-493 and ABT-530 in Adult Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
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 |
Verified date | July 2021 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
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
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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