Colitis, UlcerativePhase 4NCT02743806
Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
A Phase 4 study testing Vedolizumab in people with Colitis, Ulcerative and Crohn Disease, run by Takeda at 78 sites in 18 countries.
Trial summary
The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colitis, Ulcerative, Crohn Disease
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 78 sitesin 18 countries
- Study dates
- 1 Aug 2016to 3 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.
- In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
- A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
- A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
Who cannot join
- For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.
- Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
- If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
- Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.
Trial locations and contacts
78 sites in 18 countries.
78 sites in 18 countries
Hungary14 sites
Bekes Megyei Kozponti Korhaz
Békéscsaba, 5600
Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont
Budapest, 1076
Semmelweis Egyetem
Budapest, 1088
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, 1125
Szent Pantaleon Korhaz-Rendelointezet
Dunaújváros, 2400
Bugat Pal Korhaz
Gyöngyös, 3200
Bekes Megyei Kozponti Korhaz
Gyula, 5700
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Karolina Korhaz Rendelointezet
Mosonmagyaróvár, 9200
Kanizsai Dorottya Korhaz
Nagykanizsa, 8800
Pecsi Tudomanyegyetem
Pécs, 7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100
Czechia10 sites
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové, 500 12
Karlovarska krajska nemocnice a.s.
Karlovy Vary, Karlovarsk Kraj, 360 66
Oblastni nemocnice Kladno, a.s.
Kladno, 272 01
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
Pardubice, 532 03
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Institut klinicke a experimentalni mediciny
Prague, 140 21
ISCARE I.V.F. a.s.
Prague, 170 00
Nemocnice Strakonice, a.s.
Strakonice, 386 29
Nemocnice Tabor, a.s.
Tábor, 390 03
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 401 13
Poland10 sites
SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego
Bialystok, 15-950
10 Wojskowy Szpital Kliniczny z Poliklinika
Bydgoszcz, 85-681
Centrum Medyczne sw. Lukasza
Częstochowa, Silesian Voivodeship, 42-202
Corpora-Med
Gliwice, 44-122
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-531
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, 31-826
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632
Centralny Szpital Kliniczny MSW
Warsaw, 02-507
Ars Medica
Wroclaw, Lower Silesian Voivodeship, 53-333
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50556
Australia6 sites
Box Hill Hospital
Box Hill, 3128
Western Hospital
Footscray, Victoria, 3011
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Royal Brisbane & Women's Hospital
Herston, 4029
Cabrini Medical Centre
Malvern, Victoria, 3144
Fiona Stanley Hospital
Murdoch, 6150
Russia6 sites
City Clinical Hospital #24
Moscow, 125005
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, 603126
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, 191015
Union Clinic, LLC
Saint Petersburg, 191119
St.Petersburg Multi Field City Hospital #2
Saint Petersburg, 194354
Medical Company Hepatolog, LLC
Samara, 443093
South Korea6 sites
Yeungnam University Hospital
Daegu, 705-703
Seoul National University Hospital
Seoul, 110-744
Severance Hospital Yonsei University Health System - PPDS
Seoul, 120-752
Kyung Hee University Hospital
Seoul, 130-702
Samsung Medical Center - PPDS
Seoul, 135-710
Asan Medical Center - PPDS
Seoul, 138-736
India5 sites
VGM Hospital Institute of Gastroenterology
Coimbatore, Tamil Nadu, 641005
Owaisi Hospital and Research Centre
Hyderabad, Andhra Pradesh, 500058
Lakeshore Hospital
Kochi, Kerala, 682304
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
KEM Hospital Research Centre
Pune, Maharashtra, 411011
South Africa4 sites
Universitas Hospital
Bloemfontein, 9301
Kingsbury Hospital
Claremont, Western Cape, 7708
St Augustines Medical Centre
Durban, KwaZulu-Natal, 4001
CLINRESCO, ARWYP Medical Suites
Johannesburg, Gauteng, 1619
New Zealand3 sites
Shakespeare Specialist Group
Auckland, 620
Christchurch Hospital
Christchurch, Canterbury, 8011
Waikato Hospital
Hamilton, Waikato Region, 3240
Bulgaria2 sites
Multiprofile Hospital For Active Treatment Ruse
Rousse, 7002
City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, 1784
Estonia2 sites
West Tallinn Central Hospital
Tallinn, 10617
East Tallinn Central Hospital
Tallinn, EE-10138
Italy2 sites
Istituto Clinico Humanitas
Rozzano, 20089
Policlinico San Donato
San Donato Milanese, Milano, 20097
Romania2 sites
Colentina Clinical Hospital
Bucharest, 20125
Fundeni Clinical Institute
Bucharest, 22322
Ukraine2 sites
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava, 36011
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia, Vinnytsia Oblast, 21029
Turkey (Türkiye)1 site
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34890
About this study
Official title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
Read the detailed description
The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab.
Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive:
- Vedolizumab 300 mg
All participants will receive an intravenous (IV) infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regimen may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Being tested
- Vedolizumab
- Keywords
- Drug Therapy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Also called MLN0002, Entyvio, Kynteles
Vedolizumab IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab 300 mg | Experimental | Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years. Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.
Measured: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy [PML]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point.
Measured: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start1 Aug 2016
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Why it stopped: Early Completed - Alternative Source of Drug Available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743806
- Sponsor's protocol ID
- Vedolizumab-4013
- Other IDs
- 2016-000678-40, U1111-1180-9339, 2016
- Status last verified
- Nov 2023
- First submitted
- 15 Apr 2016
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Publications
Danese S, Lukas M, Volfova M, Rydzewska G, Adsul S, Lindner D, Jones S, Vermeire S. Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety. Ther Adv Gastroenterol. 2026 Feb 9;19:17562848251406092. doi: 10.1177/17562848251406092. eCollection 2026.
PubMed 41684725Danese S, Subramaniam K, Van Zyl J, Adsul S, Lindner D, Roth J, Vermeire S. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Aliment Pharmacol Ther. 2021 Jan;53(2):265-272. doi: 10.1111/apt.16160. Epub 2020 Nov 18.
PubMed 33210333
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
- ClinicalTrials.gov ID
- NCT02743806
- Acronym / sponsor ID
- Vedolizumab-4013
- Conditions
- Colitis, Ulcerative, Crohn Disease
- Keywords
- Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early Completed - Alternative Source of Drug Available
- Enrolment
- 331 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
Detailed description
The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab.
Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive:
- Vedolizumab 300 mg
All participants will receive an intravenous (IV) infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regimen may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab 300 mg | Experimental | Drug: VedolizumabVedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.
- In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
- A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
- A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
Key exclusion criteria (5 listed)
- For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.
- Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study.
- If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
- If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
- Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VedolizumabAlso: MLN0002, Entyvio, KyntelesVedolizumab IV infusion | Drug | Vedolizumab 300 mg |
Primary outcome
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time frame: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy [PML]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41684725Danese S, Lukas M, Volfova M, Rydzewska G, Adsul S, Lindner D, Jones S, Vermeire S. Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety. Ther Adv Gastroenterol. 2026 Feb 9;19:17562848251406092. doi: 10.1177/17562848251406092. eCollection 2026.
- Derived from this study: PubMed 33210333Danese S, Subramaniam K, Van Zyl J, Adsul S, Lindner D, Roth J, Vermeire S. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Aliment Pharmacol Ther. 2021 Jan;53(2):265-272. doi: 10.1111/apt.16160. Epub 2020 Nov 18.
- To obtain more information about this study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
78 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vedolizumab in people with Colitis, Ulcerative and Crohn Disease, run by Takeda at 78 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in Hungary, Czechia, Poland, Australia, Russia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743806, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.