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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection

NCT ID: NCT02651194

Last Updated: 2017-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C Virus (HCV) Infection

Keywords

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Treatment-naïve HCV Gentoype 2 Non-cirrhotic Chronic Hepatitis C HCV Gentoype 5 HCV Gentoype 4 HCV Gentoype 6 HCV Gentoype 1 Compensated cirrhotic Treatment-experienced HCV Gentoype 3

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-493/ABT-530

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

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

Interventions

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ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Intervention Type DRUG

Other Intervention Names

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ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Countries

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Australia Belgium Canada France Greece Italy New Zealand United Kingdom United States

References

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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.

Reference Type DERIVED
PMID: 31568620 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30977945 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30923816 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30529905 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30012435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29020583 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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2015-002353-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-462

Identifier Type: -

Identifier Source: org_study_id