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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT02743806
Date of registration: 15/04/2016
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
Scientific title: Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
Date of first enrolment: August 1, 2016
Target sample size: 331
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Australia Bulgaria Czech Republic Czechia Estonia Hungary India Italy
Korea, Republic of Latvia Malaysia New Zealand Poland Romania Russian Federation Serbia
Slovakia South Africa Taiwan Turkey Ukraine
Name:     Medical Director Clinical Science
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Received vedolizumab (excluding comparator or placebo participants) during
participation in a qualifying vedolizumab study.

2. 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.

3. 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.

4. 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.

Exclusion Criteria:

1. For the participant's particular clinical scenario, vedolizumab is currently available
to the participant through commercial channels, including reimbursement.

2. 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.

3. 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.

4. If male, the participant intends to donate sperm during the course of this study or
for 18 weeks thereafter.

5. 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.

Age minimum: 18 Years
Age maximum: 90 Years
Gender: All
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Crohn Disease
Drug: Vedolizumab
Primary Outcome(s)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: From enrolment until the time the subject exits the study (up to 3 years)]
Percentage of Participants With Adverse Events of Special Interest (AESIs) [Time Frame: From enrolment until the time the subject exits the study (up to 3 years)]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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