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OpenTrials
Completed

NCT Number: NCT04877431

A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease

The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).

This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IC Projects

Buenos Aires, C1055AAD, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult participants (greater than or equal to [>=] 18 years) or pediatric (>= 1 year and less than [<] 18) with a diagnosis of SBS who are dependent on parenteral support.
  • Have received at least one dose of teduglutide according to approved indications.
  • Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion criteria

  • Not Applicable.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Events of Special Interest (AESI)

    Time frame: Up to 24 months

    AESI will include biliary disorders and cholecystitis; pancreatic disease; cardiovascular adverse events associated with fluid overload; intestinal obstruction; stoma complications; malignancy; gastrointestinal neoplastic growth, including colorectal polys and small bowel neoplasia; adverse events associated with increased absorption of concomitant oral medications; anxiety; injection site reactions and suspected immunogenic reactions (like hypersensitivity or other reactions); embryo-fetal toxicity (assessed through follow up of all pregnancies).

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 24 months

    An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse events (SAEs) is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. Number of participants with AEs including serious and non-serious AEs will be assessed.

Secondary outcomes

  1. Percentage of Participants With Clinical Response at Week 12 and 24

    Time frame: Week 12 and 24

    Clinical response will be defined as a 20 percent (%) or more reductions on weekly parenteral support volume.

  2. Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24

    Time frame: Baseline, Week 12 and 24

    Parenteral support volume will be assessed at baseline (before treatment), and at Week 12, and 24.

  3. Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24

    Time frame: Baseline, Week 12 and 24

    Change from baseline in number of days per week requiring parenteral support will be assessed at baseline (before treatment), and at Week 12 and 24.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Teduglutide (Revestive®) in Adult and Pediatric Patients With Short Bowel Syndrome in Argentina

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 7, 2021
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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