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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04901195
Registration number
NCT04901195
Ethics application status
Date submitted
20/05/2021
Date registered
25/05/2021
Titles & IDs
Public title
A Study to Test the Long-term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
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Scientific title
A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
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Secondary ID [1]
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2020-004179-42
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Secondary ID [2]
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HS0005
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Universal Trial Number (UTN)
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Trial acronym
BE HEARD EXT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bimekizumab
Experimental: Bimekizumab dosing regimen 1 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 during the open-label extension period.
Experimental: Bimekizumab dosing regimen 2 - Subjects participating in the study will receive assigned bimekizumab dosing regimen 2 during the open-label extension period.
Treatment: Drugs: Bimekizumab
Subjects will receive bimekizumab at pre-specified time-points.
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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 treatment-emergent adverse events (TEAEs) during the study
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
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Timepoint [1]
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From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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Secondary outcome [1]
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Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
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Assessment method [1]
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A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
* Results in death
* Is life-threatening
* Requires inpatient hospitalization or prolongation of existing hospitalization
* Results in persistent disability/incapacity
* Is a congenital anomaly/birth defect
* Important medical events
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Timepoint [1]
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From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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Secondary outcome [2]
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Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
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Assessment method [2]
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An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.
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Timepoint [2]
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From Baseline (Day 1) until end of Safety Follow-Up (up to Week 196)
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Secondary outcome [3]
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Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
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Assessment method [3]
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HiSCR50 is defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.
Results will be presented individually per week listed under time points.
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Timepoint [3]
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Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
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Secondary outcome [4]
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Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
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Assessment method [4]
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HiSCR75 is defined as at least a 75 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining tunnel count.
Results will be presented individually per week listed under time points.
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Timepoint [4]
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Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
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Secondary outcome [5]
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Percentage of participants with Flare
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Assessment method [5]
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Flare is defined as a =25 % increase in abscess and inflammatory nodule (AN) count with an absolute increase in AN count of =2 relative to Baseline.
Results will be presented individually per week listed under time points.
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Timepoint [5]
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Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
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Secondary outcome [6]
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Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
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Assessment method [6]
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The 4 items on the HSSQ assess the study participant's perception of the core symptoms of HS experienced in the past 7 days - pain, smell or odor, drainage or oozing from HS lesions, and itch on an 11-point numeric rating scale with higher scores indicating higher symptom level.
Results will be presented individually per week listed under time points.
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Timepoint [6]
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Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
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Secondary outcome [7]
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Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
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Assessment method [7]
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The DLQI is a skin disease specific questionnaire aimed at the evaluation of how the disease affects participants health related quality of life (QOL). The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QOL.
Results will be presented individually per week listed under time points.
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Timepoint [7]
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Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100, Week 116, Week 132, Week 148, Week 164, and Week 180
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Eligibility
Key inclusion criteria
* Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
* Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
* A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
1. Not a woman of childbearing potential (WOCBP) OR
2. A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)
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Minimum age
18
Years
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Maximum age
No limit
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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
* Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
* Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
* Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
* Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
* Study participant plans to participate in another study of a medicinal product or device under investigation during this 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
Active, not recruiting
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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
27/05/2021
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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
28/07/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
658
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Hs0005 30015 - Campbelltown
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Recruitment hospital [2]
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Hs0005 30016 - Carlton
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Recruitment hospital [3]
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Hs0005 30011 - East Melbourne
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Hs0005 30017 - Kogarah
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Hs0005 30018 - Parkville
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Hs0005 30014 - St Leonards
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Hs0005 30009 - Westmead
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Recruitment hospital [8]
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Hs0005 30012 - Woolloongabba
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Recruitment postcode(s) [1]
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- Campbelltown
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- Carlton
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- East Melbourne
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- Kogarah
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- Parkville
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- St Leonards
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- Westmead
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Recruitment postcode(s) [8]
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- Woolloongabba
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Recruitment outside Australia
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Antalya
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
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I?zmir
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United Kingdom
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Leeds
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
UCB Biopharma SRL
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)
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Trial website
https://clinicaltrials.gov/study/NCT04901195
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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UCB Cares
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001 844 599 2273
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
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Available to whom?
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.Vivli.org
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04901195