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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02939989
Registration number
NCT02939989
Ethics application status
Date submitted
19/10/2016
Date registered
20/10/2016
Date last updated
4/05/2022
Titles & IDs
Public title
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
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Scientific 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)
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Secondary ID [1]
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2016-002491-26
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Secondary ID [2]
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M15-942
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Universal Trial Number (UTN)
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Trial acronym
MAGELLAN-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus Infection
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - Glecaprevir/Pibrentasvir
Treatment: Drugs - Ribavirin
Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks - Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
Experimental: Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks - Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
Treatment: Drugs: Sofosbuvir
Tablet for oral administration
Treatment: Drugs: Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Treatment: Drugs: Ribavirin
Tablet for oral administration
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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Assessment method [1]
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SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.
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Timepoint [1]
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12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
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Secondary outcome [1]
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Percentage of Participants With On-treatment Virologic Failure
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Assessment method [1]
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On-treatment virologic failure was defined as meeting one of the following:
confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the treatment period; or
confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
HCV RNA = 15 IU/mL at end of treatment with at least 6 weeks of treatment.
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Timepoint [1]
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12 or 16 weeks depending on the treatment regimen
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Secondary outcome [2]
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Percentage of Participants With Post-treatment Relapse
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Assessment method [2]
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Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
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Timepoint [2]
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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).
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Eligibility
Key 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.
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Minimum age
12
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/07/2021
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Sample size
Target
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital /ID# 200944 - Herston
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Recruitment hospital [2]
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The Royal Melbourne Hospital /ID# 155727 - Parkville
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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California
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United States of America
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Maryland
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Michigan
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New York
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North Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Canada
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Alberta
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China
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Beijing
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China
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Chengdu
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China
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Chongqing
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China
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Fuzhou
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Germany
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Nordrhein-Westfalen
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Germany
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Hamburg
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Seoul
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Auckland
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New Zealand
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Waikato
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New Zealand
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Otago
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Russian Federation
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Samarskaya Oblast
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Madrid
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Solna
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Switzerland
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Bern
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02939989
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02939989
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