A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using GATTEX (GATTEX KAB)

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

The main aim of this study is to document the level of knowledge and assess attitudes and behaviors of both participants and physicians regarding the risks and safe use of GATTEX. The survey will be done via internet, telephone, or paper and patients will be able to choose the method that is preferred. No study medicines will be provided to patients in this study.

Study Overview

• Status: Recruiting
• Conditions: Short Bowel Syndrome (SBS)
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1 866 842 5335; Email: ClinicalTransparency@takeda.com

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Recruiting
      • Shire-NPS Pharmaceuticals, INC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants and prescriber who have completed Wave 5 of the GATTEX participant KAB Survey will be observed in this REMS survey.

Description

Participant inclusion criteria:

Participants who are 18 years of age or older and who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in the survey. A caregiver may participate in this survey on behalf of a patient who is eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge, Attitudes and Behavior (KAB) Survey, are eligible.

Prescriber inclusion criteria:

HCPs (adult and pediatric) in the United States who can provide a 10-digit National Provider Identifier (NPI) number and who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training (Prescriber Education Slide Deck) are eligible for participation in the survey. Note: HCPs who have previously participated in a GATTEX HCP KAB Survey, are eligible.

Participant and Prescriber exclusion criteria:

• Respondents who do not agree to participate in the survey.
• Respondents who are currently working for and/or whose immediate family members who are currently working for Takeda Pharmaceutical Inc., NPS Pharmaceuticals, Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey.
• Respondents who reported having a conflict of interest.

Further details associated with respondents who do not meet the exclusion criteria established above, will be provided in the assessment report.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GATTEX: Participants; Participants who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in this Risk Evaluation and Mitigation Strategy (REMS) survey for up to 10 years via internet, telephone, and paper.	Other: No Intervention; This is non-interventional study.
GATTEX: Healthcare Providers (Prescribers); HCPs (adult and pediatric) in the United States (US) who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training are eligible for participation in this REMS survey for up to 10 years via internet, telephone, and paper.	Other: No Intervention; This is non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants and Prescribers Providing Correct Responses to Questions	All question for key risk message and about GATTEX will be asked through a questionnaire, Participant or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants and Prescribers Providing At Least 80 Percent (%) Correct Responses to Each key Risk Messages	The questions will be asked to participants and HCPs and will be counted as correct if 80% of the correct responses are provided and not more than 1 incorrect response is provided. In key risk message, general question about GATTEX will be asked, participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.	Up to 10 years
Number of Participants and Prescribers who Demonstrated Understanding of Each key Risk Messages	Understanding demonstration is defined as respondents who answered 80% or more questions/items in a key risk message correctly. In key risk message, general question about GATTEX will be asked, participants or HCPs would need to respond true or false to each question based upon understanding and knowledge. Respondents could be participants or HCPs.	Up to 10 years

Collaborators and Investigators

• Sponsor: Shire
• Investigators: Study Director: Study Director, Shire

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Short Bowel Syndrome
• Other Study ID Numbers: TAK-633-4008; EUPAS48716 (Registry Identifier: EU PAS Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No