Quantitative Testing of Patient and Prescriber Knowledge, About GATTEX (Teduglutide) for Injection Safety and Use Information

Study identification

• EU PAS number:
  EUPAS48716
• Study ID:
  49716
• Official title and acronym:
  Quantitative Testing of Patient and Prescriber Knowledge, About GATTEX (Teduglutide) for Injection Safety and Use Information
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study is about learning and documenting how well participants and physicians understand how to use GATTEX and about potential risks by using a survey (called Knowledge Assessment Survey). This survey, which is conducted every two years, is part of the Gattex Risk Evaluation and Mitigation Strategy (REMS). REMS is a safety program required by the US health authority (FDA) for certain medicines that have serious risks. REMS intends to help reduce these risks while still allowing treatment. The goal is to make sure these medicines are used in the safest way possible. The main aim of this survey is to find out how well participants and physicians understand the checkups and tests (so called monitoring) participants should have while taking GATTEX, and the possible risks or of using GATTEX to treat Short Bowel Syndrome.; The knowledge assessment survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred.; No study medicines will be provided to participants in this study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual:01/08/2013

Study start date

Actual:01/08/2013

Date of final study report

Planned:31/12/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

NCT05561647 (https://clinicaltrials.gov/ct2/show/NCT05561647),TAK-633-4008 (https://clinicaltrials.takeda.com/study-detail/43674fa3720540ed?idFilter=%5B%22TAK-633-4008%22%5D)