The expanded access program (EAP) allows people to gain access to an unlicensed treatmenton compassionate grounds. This EAP provides children and teenagers with UlcerativeColitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study inthe United States (US) with continued access to Vedolizumab Intravenous (IV) which isgiven as infusion into a vein (intravenously IV) until it becomes commercially availablein the US. To be able to participate in this EAP, children and teenagers must stillbenefit from the treatment with Vedolizumab IV. According to the participant's treatinghealthcare professional (HCP): there are no comparable and satisfactory alternativetreatment options in the local market, or the participant would be negatively affectedwithout continued access to vedolizumab IV.
Not Provided
Drug: Vedolizumab IV
Participants will continue to receive vedolizumab IV at the same dose administered at the
end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks.
• Other Names:
- MLN0002
- ENTYVIO
- KYNTELES
Inclusion Criteria:
1. The participant has UC or CD and is of age less than (<) 18 years at the time of
final treatment completion of Vedolizumab-2005.
2. The participant is demonstrating continued clinical benefit from vedolizumab IV for
the treatment of UC or CD that outweighs possible risks.
3. The participant, participant's legally authorized representative, or adult caregiver
is informed of the nature of this expanded access program and has provided signed
and dated written informed consent and/or pediatric assent.
4. The participant does not have any condition, including laboratory test result, that
in the opinion of the investigator may compromise the participant's safety.
5. The participant does not have a known hypersensitivity to vedolizumab or its
components.
6. According to the participant's treating healthcare professional (HCP): there are no
comparable and satisfactory alternative treatment options in the local market, or
the participant would be negatively affected without continued access to vedolizumab
IV.
7. Female participants of childbearing potential only:
- The participant has agreed to be abstinent or agreed to comply with the
applicable contraceptive requirements of this protocol for the duration of the
expanded access program and for 18 weeks after completion of the last dose of
vedolizumab.
- The participant is not pregnant or breastfeeding.
- The participant will not donate ova during the course of the program and for 18
weeks after the last dose of vedolizumab.
8. Male participants only:
- The participant has agreed to comply with the applicable contraceptive
requirements of this protocol for the duration of the expanded access program
and for 18 weeks after the last dose of vedolizumab.
- The participant has agreed to not donate sperm during the course of the program
and for 18 weeks after the last dose of vedolizumab.
Exclusion Criteria:
-No specific exclusion criteria.
University of California San Francisco
San Francisco, California, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Takeda Contact
+1-877-825-3327
medinfoUS@takeda.com
Study Director, Study Director
Takeda