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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab IV | Drug | 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:
|
Inclusion Criteria:
The participant has UC or CD and is of age less than (<) 18 years at the time of final treatment completion of Vedolizumab-2005.
The participant is demonstrating continued clinical benefit from vedolizumab IV for the treatment of UC or CD that outweighs possible risks.
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.
The participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety.
The participant does not have a known hypersensitivity to vedolizumab or its components.
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.
Female participants of childbearing potential only:
Male participants only:
Exclusion Criteria:
-No specific exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Available | San Francisco | California | 94158 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language. | View source |
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Children's Center for Digestive Healthcare | Available | Atlanta | Georgia | 30342 | United States |
|
| Seattle Children's Hospital | Available | Seattle | Washington | 98105 | United States |
|
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |