Clinical trial NCT02636595: The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
Official title: A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus
Keywords: Hepatitis C Genotype 4
Hepatitis C
Chronic Hepatitis C
Hepatitis C Genotype 6
Hepatitis C Genotype 5
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.


Eligibility criteria: Inclusion Criteria:

1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
2. Chronic HCV infection.
3. HCV treatment-naïve or treatment experienced (interferon \[IFN\] or pegylated interferon \[pegIFN\] with or without ribavirin \[RBV\]; sofosbuvir \[SOF\] plus RBV with or without pegIFN).
4. Non-cirrhotic participants.

Exclusion Criteria:

1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
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 in the opinion of the investigator.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. Co-infection with more than one HCV genotype.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment through 12 weeks after the last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.