A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
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ClinicalTrials.gov Identifier: NCT01995071 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Results First Posted : October 16, 2017
Last Update Posted : October 16, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis | Drug: ABT-493 Drug: ABT-530 Drug: ABT-450/r/ABT-267, ABT-333 Drug: Ribavirin (RBV) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 Non-cirrhotic
ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-493
Tablet
Other Name: glecaprevir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 2 Non-cirrhotic
ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-493
Tablet
Other Name: glecaprevir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 3 Non-cirrhotic
ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-493
Tablet
Other Name: glecaprevir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 4 Non-cirrhotic
ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-493
Tablet
Other Name: glecaprevir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 5 Compensated cirrhotic
ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-493
Tablet
Other Name: glecaprevir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 6 Non-cirrhotic
ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-530
Tablet
Other Name: pibrentasvir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 7 Non-cirrhotic
ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-530
Tablet
Other Name: pibrentasvir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 8 Non-cirrhotic
ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-530
Tablet
Other Name: pibrentasvir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 9 Non-cirrhotic
ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-530
Tablet
Other Name: pibrentasvir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 10 Compensated cirrhotic
ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-530
Tablet
Other Name: pibrentasvir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 11 Non-cirrhotic
ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-493
Tablet
Other Name: glecaprevir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
Experimental: Arm 12 Non-cirrhotic
ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
|
Drug: ABT-530
Tablet
Other Name: pibrentasvir Drug: ABT-450/r/ABT-267, ABT-333 Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
Drug: Ribavirin (RBV) Tablet |
- Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment [ Time Frame: Day 1 through prior to first dose of the combination regimen on Study Day 4 ]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.
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after last actual dose of combination study drug ]SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.
- Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 87 days ]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.
- Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of combination study drug ]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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995071
Study Director: | AbbVie Inc | AbbVie |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT01995071 |
Other Study ID Numbers: |
M13-595 |
First Posted: | November 26, 2013 Key Record Dates |
Results First Posted: | October 16, 2017 |
Last Update Posted: | October 16, 2017 |
Last Verified: | September 2017 |
Chronic Hepatitis C Cirrhosis Child Pugh A Hepatitis C virus Compensated Cirrhosis |
Hepatitis C Genotype 1 Hepatitis C Interferon-Free Cirrhotic |
Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Cirrhosis Fibrosis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Pathologic Processes Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |