Chronic Hepatitis CPhase 2NCT01995071

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)

A Phase 2 study testing ABT-493, ABT-530 and ABT-450/r/ABT-267, ABT-333 in people with Chronic Hepatitis C and Hepatitis C Virus, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis
What is being tested?: ABT-493, ABT-530 and ABT-450/r/ABT-267, ABT-333
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: No sites listed yet
Study dates: Nov 2013to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

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

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.

Conditions: Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis
Being tested: ABT-493, ABT-530, ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
Keywords: Chronic Hepatitis C, Cirrhosis, Child Pugh A, Hepatitis C virus, Compensated Cirrhosis, Hepatitis C Genotype 1, Hepatitis C, Interferon-Free, Cirrhotic
Medical subject headings: Hepatitis C, Chronic, Hepatitis C, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-493Drug
Also called glecaprevir
Tablet
ABT-530Drug
Also called pibrentasvir
Tablet
ABT-450/r/ABT-267, ABT-333Drug
Also called ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAK
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirin (RBV)Drug
Tablet

Study groups in NCT01995071
Study group	Role	What they receive
Arm 1 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 2 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 3 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 4 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 5 Compensated cirrhotic	Experimental	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 Receives: Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 6 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-530; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 7 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-530; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 8 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-530; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 9 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-530; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 10 Compensated cirrhotic	Experimental	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 Receives: Drug: ABT-530; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 11 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-493; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)
Arm 12 Non-cirrhotic	Experimental	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 Receives: Drug: ABT-530; Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 through prior to first dose of the combination regimen on Study Day 4

Secondary outcomes (3)

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 [<LLOQ]) 12 weeks after the last dose of combination study drug.
Measured: 12 weeks after last actual dose of combination study drug
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.
Measured: Up to 87 days
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.
Measured: From the end of treatment through 12 weeks after the last dose of combination study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Jun 2015

First posted26 Nov 2013 (estimated)
Study startNov 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01995071
Sponsor's protocol ID: M13-595
Status last verified: Jul 2021
First submitted: 21 Nov 2013
Last updated: 12 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26183611
Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1546-55. doi: 10.1128/AAC.02264-15.
PubMed 26711747

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01995071
Acronym / sponsor ID: M13-595
Conditions: Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis
Keywords: Chronic Hepatitis C, Cirrhosis, Child Pugh A, Hepatitis C virus, Compensated Cirrhosis, Hepatitis C Genotype 1, Hepatitis C, Interferon-Free
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 26 Nov 2013 (estimated)
Results: Posted 16 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Arm 1 Non-cirrhotic	Experimental	Drug: ABT-493, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 2 Non-cirrhotic	Experimental	Drug: ABT-493, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 3 Non-cirrhotic	Experimental	Drug: ABT-493, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 4 Non-cirrhotic	Experimental	Drug: ABT-493, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 5 Compensated cirrhotic	Experimental	Drug: ABT-493, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 6 Non-cirrhotic	Experimental	Drug: ABT-530, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 7 Non-cirrhotic	Experimental	Drug: ABT-530, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 8 Non-cirrhotic	Experimental	Drug: ABT-530, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 9 Non-cirrhotic	Experimental	Drug: ABT-530, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 10 Compensated cirrhotic	Experimental	Drug: ABT-530, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 11 Non-cirrhotic	Experimental	Drug: ABT-493, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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
Arm 12 Non-cirrhotic	Experimental	Drug: ABT-530, Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin (RBV)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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-493Also: glecaprevirTablet	Drug	Arm 1 Non-cirrhotic, Arm 11 Non-cirrhotic, Arm 2 Non-cirrhotic, Arm 3 Non-cirrhotic, Arm 4 Non-cirrhotic, Arm 5 Compensated cirrhotic
ABT-530Also: pibrentasvirTablet	Drug	Arm 10 Compensated cirrhotic, Arm 12 Non-cirrhotic, Arm 6 Non-cirrhotic, Arm 7 Non-cirrhotic, Arm 8 Non-cirrhotic, Arm 9 Non-cirrhotic
ABT-450/r/ABT-267, ABT-333Also: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAKTablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet	Drug	Arm 1 Non-cirrhotic, Arm 10 Compensated cirrhotic, Arm 11 Non-cirrhotic, Arm 12 Non-cirrhotic, Arm 2 Non-cirrhotic, Arm 3 Non-cirrhotic, Arm 4 Non-cirrhotic, Arm 5 Compensated cirrhotic, Arm 6 Non-cirrhotic, Arm 7 Non-cirrhotic, Arm 8 Non-cirrhotic, Arm 9 Non-cirrhotic
Ribavirin (RBV)Tablet	Drug	Arm 1 Non-cirrhotic, Arm 10 Compensated cirrhotic, Arm 11 Non-cirrhotic, Arm 12 Non-cirrhotic, Arm 2 Non-cirrhotic, Arm 3 Non-cirrhotic, Arm 4 Non-cirrhotic, Arm 5 Compensated cirrhotic, Arm 6 Non-cirrhotic, Arm 7 Non-cirrhotic, Arm 8 Non-cirrhotic, Arm 9 Non-cirrhotic

Primary outcome

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.

3 secondary outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after last actual dose of combination study drug
Percentage of Participants With On-treatment Virologic Failure
Time frame: Up to 87 days
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

Results and safety

Results posted to the registry on 16 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 Non-cirrhotic	8	7
Arm 2 Non-cirrhotic	8	8
Arm 3 Non-cirrhotic	9	8
Arm 4 Non-cirrhotic	8	8
Arm 5 Compensated Cirrhotic	8	7
Arm 6 Non-cirrhotic	8	8
Arm 7 Non-cirrhotic	8	7
Arm 8 Non-cirrhotic	8	6
Arm 9 Non-cirrhotic	8	7
Arm 10 Compensated Cirrhotic	8	8
Arm 11 Non-cirrhotic	8	7
Arm 12 Non-cirrhotic	0	0

Primary outcome: 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. Mean (Standard Deviation). Unit: Log10 IU/mL

Measure	Arm 1 Non-cirrhotic n = 8	Arm 2 Non-cirrhotic n = 8	Arm 3 Non-cirrhotic n = 9	Arm 4 Non-cirrhotic + Arm 5 Compensated Cirrhotic n = 16	Arm 6 Non-cirrhotic n = 8	Arm 7 Non-cirrhotic + Arm 10 Compensated Cirrhotic n = 16	Arm 8 Non-cirrhotic n = 8	Arm 9 Non-cirrhotic n = 8	Arm 11 Non-cirrhotic n = 8	Arm 12 Non-cirrhotic n = 0
Value	-4.11 (0.47)	-4.02 (0.66)	-4.31 (0.26)	-4.06 (0.56)	-3.38 (0.77)	-4.21 (0.42)	-4.25 (0.49)	-4.08 (0.45)	-3.79 (1.21)	–

Population analysed: Monotherapy Analysis Sets for Substudy 1 (Arms 1-5, 11) and SubStudy 2 (Arms 6-10, 12) are defined as all participants who received at least 1 dose of monotherapy and have a baseline and at least 1 postbaseline measurement of HCV RNA during monotherapy. Data for subjects who received the same treatment (Arms 4+5; Arms 7+10) were analyzed together.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16.5 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 Non-cirrhotic	1 of 8 (12.5%)	8 of 8 (100%)	Not reported
Arm 2 Non-cirrhotic	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Arm 3 Non-cirrhotic	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
Arm 4 Non-cirrhotic	0 of 8 (0%)	8 of 8 (100%)	Not reported
Arm 5 Compensated Cirrhotic	1 of 8 (12.5%)	7 of 8 (87.5%)	Not reported
Arm 6 Non-cirrhotic	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Arm 7 Non-cirrhotic	0 of 8 (0%)	8 of 8 (100%)	Not reported
Arm 8 Non-cirrhotic	1 of 8 (12.5%)	4 of 8 (50%)	Not reported
Arm 9 Non-cirrhotic	1 of 8 (12.5%)	5 of 8 (62.5%)	Not reported
Arm 10 Compensated Cirrhotic	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Arm 11 Non-cirrhotic	0 of 8 (0%)	7 of 8 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26183611Lawitz 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.
Derived from this study: PubMed 26711747Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1546-55. doi: 10.1128/AAC.02264-15.
Related InfoLink provided by the sponsor.

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Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABT-493, ABT-530 and ABT-450/r/ABT-267, ABT-333 in people with Chronic Hepatitis C and Hepatitis C Virus, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01995071, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.