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.
Study Type
EXPANDED_ACCESS
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
University of California San Francisco
San Francisco, California, United States
AVAILABLEChildren's Center for Digestive Healthcare
Atlanta, Georgia, United States
AVAILABLESeattle Children's Hospital
Seattle, Washington, United States
AVAILABLEThis platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.