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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

NCT ID: NCT02446717

Last Updated: 2017-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

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 ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

Detailed Description

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Conditions

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Chronic Hepatitis C Hepatitis C Virus HCV Direct-Acting Antiviral Agent (DAA)-Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493, ABT-530

Intervention Type DRUG

ABT-493 (tablet) dosed with ABT-530 (tablet)

Arm B

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493, ABT-530

Intervention Type DRUG

ABT-493 (tablet) dosed with ABT-530 (tablet)

ribavirin (RBV)

Intervention Type DRUG

Tablet

Arm C

ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

Group Type EXPERIMENTAL

ABT-493, ABT-530

Intervention Type DRUG

ABT-493 (tablet) dosed with ABT-530 (tablet)

Arm D

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

Arm E

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

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

ABT-493 (tablet) dosed with ABT-530 (tablet)

Intervention Type DRUG

ribavirin (RBV)

Tablet

Intervention Type DRUG

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 ABT-493/ABT-530 (ABT-493 coformulated with ABT-267) also known as MAVYRET ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Eligibility Criteria

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Inclusion Criteria

1. Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
2. Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
3. Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)

Exclusion Criteria

1. History of severe, life-threatening or other significant sensitivity to any drug
2. 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
3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
5. Co-infection with more than one HCV genotype
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

References

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Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW, Landis CS, Gordon SC, Flamm SL, Fried MW, Bernstein DE, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017 Aug;66(2):389-397. doi: 10.1002/hep.29081. Epub 2017 Apr 10.

Reference Type RESULT
PMID: 28128852 (View on PubMed)

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)

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)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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2015-002350-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-410

Identifier Type: -

Identifier Source: org_study_id