This study is not accepting new patients

Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA

a study on Crohn's Disease Inflammatory Bowel Disease Ulcerative Colitis

Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at UCSF
Dates
study started
Principal Investigator
by Melvin Heyman, Dr. (ucsf)

Description

Summary

The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study in the United States (US) with continued access to Vedolizumab Intravenous (IV) which is given as infusion into a vein (intravenously IV) until it becomes commercially available in the US. To be able to participate in this EAP, children and teenagers must still benefit from the treatment with Vedolizumab IV. 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.

Official Title

Expanded Access Program for United States of America: Vedolizumab Intravenous for the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Keywords

Crohn's Disease, Ulcerative Colitis, Drug Therapy, Crohn Disease, Vedolizumab IV

Eligibility

You can join if…

Open to people ages 2 years and up

  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.

You CAN'T join if...

-No specific exclusion criteria.

Locations

  • University of California San Francisco not accepting new patients
    San Francisco 5391959 California 5332921 94158 United States
  • Seattle Children's Hospital not accepting new patients
    Seattle 5809844 Washington 5815135 98105 United States
  • Children's Center for Digestive Healthcare not accepting new patients
    Atlanta 4180439 Georgia 4197000 30342 United States

Lead Scientist at University of California Health

Details

Status
not accepting new patients
Start Date
Sponsor
Takeda
ID
NCT06856135
Study Type
Expanded Access
Last Updated