Clinical trial NCT02939989: Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Keywords: Chronic Hepatitis C (HCV)
HCV Genotype 1 (HCV GT1)
HCV Genotype 2 (HCV GT2)
HCV Genotype 3 (HCV GT3)
HCV Genotype 4 (HCV GT4)
HCV Genotype 5 (HCV GT5)
HCV Genotype 6 (HCV GT6)
Compensated Cirrhosis
Non-cirrhotics
Virologic failure
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

Detailed description: This study enrolled HCV infected adults who had experienced virologic failure following treatment with glecaprevir/pibrentasvir or paritaprevir/ritonavir/ombitasvir + dasabuvir (DSV) (3D) or paritaprevir/ritonavir/ombitasvir (2D) regimens in one of the following AbbVie hepatitis C virus parent studies:

* M13-594 (NCT02640157)
* M13-596 (NCT02692703)
* M14-172 (NCT02642432)
* M14-242 (NCT02493855)
* M14-868 (NCT02243293)
* M15-410 (NCT02446717)
* M15-592 (NCT03222583)
* M16-126 (NCT02966795)
* M16-135 (NCT03089944)

Eligibility criteria: Inclusion Criteria:

* Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
* Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
* Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
* Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
* Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.

Exclusion Criteria:

* History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
* Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
* 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).
* Screening laboratory analyses showing calculated creatinine clearance \< 30 mL/min.
* Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
* Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.

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, Week 24 or Week 28 depending on the treatment regimen.
Secondary outcomes:
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: 12 or 16 weeks depending on the treatment regimen
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast /ID# 155719
state: Alabama
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group /ID# 155714
state: California
city: Baltimore
country: United States
facility: Digestive Disease Associates - Baltimore /ID# 155713
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 155720
state: Michigan
city: Buffalo
country: United States
facility: University of Buffalo /ID# 155721
state: New York
city: Statesville
country: United States
facility: Carolinas Center For Liver Dis /ID# 155731
state: North Carolina
city: Germantown
country: United States
facility: Gastro One /ID# 155729
state: Tennessee
city: San Antonio
country: United States
facility: TX Liver Inst, Americ Res Corp /ID# 157881
state: Texas
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 200944
state: Queensland
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 155727
state: Victoria
city: Calgary
country: Canada
facility: University of Calgary /ID# 155726
state: Alberta
city: Beijing
country: China
facility: Beijing Di Tan Hospital, Capital Medical University /ID# 218496
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 217613
city: Chongqing
country: China
facility: The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495
city: Düsseldorf
country: Germany
facility: Zentru fur HIV und Heaptogastroenterologie /ID# 155592
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg /ID# 155733
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 214844
city: Grafton
country: New Zealand
facility: Auckland City Hospital /ID# 200945
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 155728
state: Waikato
city: Otago
country: New Zealand
facility: Dunedin Hospital /ID# 155591
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog /ID# 214314
state: Samarskaya Oblast
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734
state: Madrid
city: Solna
country: Sweden
facility: Duplicate_Karolinska Univ Sjukhuset /ID# 155735
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern /ID# 155716
city: London
country: United Kingdom
facility: Duplicate_Imperial College Healthcare NHS Trust /ID# 155718
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8. No abstract available.