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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06254950
Registration number
NCT06254950
Ethics application status
Date submitted
2/02/2024
Date registered
12/02/2024
Titles & IDs
Public title
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
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Scientific title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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2023-506769-67
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Secondary ID [2]
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TAK-279-UC-2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAK-279
Treatment: Drugs - Placebo
Experimental: TAK-279 Dose 1 - TAK-279, capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.
Experimental: TAK-279 Dose 2 - TAK-279, capsules, orally at Dose 2 for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.
Placebo comparator: Placebo - TAK-279 matching placebo capsules, orally, for 12 weeks followed by TAK-279 capsules, orally at Dose 1 up to Week 52 as per investigator's discretion.
Treatment: Drugs: TAK-279
TAK-279 capsules.
Treatment: Drugs: Placebo
TAK-279 placebo-matching capsules.
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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 Achieving Clinical Remission at Week 12 Based on Modified Mayo Score (mMS)
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Assessment method [1]
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The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component subscore ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined an mMS of =2 with SF subscore = 1, RB subscore = 0, and ES = 1 (score of 1 modified to exclude friability).
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving Clinical Response at Week 12 Based on Modified Mayo Score (mMS)
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Assessment method [1]
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Clinical response defined as reduction from baseline in mMS of =2 points and =30% from baseline and a decrease from baseline in the RB subscore of =1 point or an absolute RB subscore of =1 point at Week 12.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving Symptomatic Remission at Week 12
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Assessment method [2]
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Symptomatic remission is defined as a RB subscore of 0 and SF subscore of =1.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants Achieving Endoscopic Improvement at Week 12
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Assessment method [3]
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Endoscopic improvement defined as a modified Mayo ES of =1 (score of 1 modified to exclude friability).
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Achieving Endoscopic Remission at Week 12
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Assessment method [4]
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Endoscopic remission defined as a modified Mayo ES of 0.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants With no Bowel Urgency at Week 12
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Assessment method [5]
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Bowel urgency measured by the bowel urgency electronic diary (eDiary) item at Week 12.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Participants With no Abdominal Pain at Week 12
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Assessment method [6]
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Abdominal pain measured by abdominal pain eDiary item at Week 12.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score =170 at Week 12
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Assessment method [7]
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The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) as Measured by IBDQ Total Score at Week 12
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Assessment method [8]
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The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel function (10 items), emotional status (12 items), systemic symptoms (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Change From Baseline in Fatigue as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
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Assessment method [9]
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The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.
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Timepoint [9]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one conventional, biologic or advance therapy for UC.
4. Participants must meet the contraception recommendations.
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Minimum age
18
Years
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Maximum age
75
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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
1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
29/03/2024
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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
4/08/2027
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Actual
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Sample size
Target
207
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Nepean Clinical School - Kingswood
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Sydney
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Western Health/Footscray Hospital - Melbourne
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Recruitment hospital [4]
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Harry Perkins Medical Research Institute Fiona Stanley Hospital - Murdoch
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2747 - Kingswood
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Recruitment postcode(s) [2]
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2139 - Sydney
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Recruitment postcode(s) [3]
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3011 - Melbourne
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
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United Kingdom
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Cambridge
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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
Takeda
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Ethics approval
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Summary
Brief summary
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.
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Trial website
https://clinicaltrials.gov/study/NCT06254950
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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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Study Director
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Takeda
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Contact person for public queries
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Takeda Contact
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+1-877-825-3327
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[email protected]
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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?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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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://vivli.org/ourmember/takeda/
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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/NCT06254950