NCT02651194

Brief Summary

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 16, 2017

Completed
Last Updated

October 16, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

January 7, 2016

Results QC Date

August 17, 2017

Last Update Submit

September 14, 2017

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Keywords

Treatment-naïveHCV Gentoype 2Non-cirrhoticChronic Hepatitis CHCV Gentoype 5HCV Gentoype 4HCV Gentoype 6HCV Gentoype 1Compensated cirrhoticTreatment-experiencedHCV Gentoype 3

Outcome Measures

Primary Outcomes (1)

  • 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 study drug

    12 weeks after the last actual dose of study drug

Secondary Outcomes (2)

  • Percentage of Participants With On-treatment Virologic Failure

    up to 12 weeks

  • Percentage of Participants With Post-treatment Relapse

    From the end of treatment through 12 weeks after the last dose of study drug

Study Arms (1)

ABT-493/ABT-530

EXPERIMENTAL

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Drug: ABT-493/ABT-530

Interventions

ABT-493/ABT-530DRUG

Tablet; ABT-493 coformulated with ABT-530

Also known as: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET
ABT-493/ABT-530

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic hepatitis C virus (HCV) infection
  • Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
  • Subject must be HCV treatment-naïve or have failed previous HCV treatment.
  • Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).
  • Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

You may not qualify if:

  • History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
  • Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.
  • Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18.

    PMID: 31568620DERIVED

  • Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.

    PMID: 30977945DERIVED

  • Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.

    PMID: 30923816DERIVED

  • Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24.

    PMID: 30529905DERIVED

  • Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.

    PMID: 30012435DERIVED

  • Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Brau N, Brown A, Pol S, Leroy V, Persico M, Moreno C, Colombo M, Yoshida EM, Nelson DR, Collins C, Lei Y, Kosloski M, Mensa FJ. Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. N Engl J Med. 2017 Oct 12;377(15):1448-1455. doi: 10.1056/NEJMoa1704053.

    PMID: 29020583DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis CInfections

Interventions

glecaprevirpibrentasvirglecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • AbbVie Inc

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

December 1, 2015

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

October 16, 2017

Results First Posted

October 16, 2017

Record last verified: 2017-09