Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients

NCT03562130 | Completed Phase 4

• 2 other identifiers: P171002J2017-001405-32
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient

Conditions

Short Bowel Syndrome

Keywords

Teduglutide; Short Bowel Syndrome; Parenteral nutrition; Intestinal failure

Outcome Measures

Primary Outcomes (1)

• Decrease in parenteral nutrition: Parenteral Nutrition/Resting Energy Expenditure (PN/REE)

  Evaluate the efficacy of Revestive® treatment

  At week 24

Secondary Outcomes (15)

• Ostomy output defined as stool balance testing, urine output and plasma citrulline

  up to week 48

• Change in days per week of Parenteral Nutrition (PN)

  up to week 48

• Change in number of stool per day

  up to week 48

• Change in stools consistency (Bristol stool chart)

  up to week 48

• Ingesta (calorimetric measure)

  Every 4 weeks up to week 48

Study Arms (1)

Revestive

EXPERIMENTAL

Revestive® (teduglutide)is administered in children sub cutaneous injection at 0.05 mg/kg body weight once daily

Drug: Teduglutide

Interventions

Teduglutide DRUG

Daily sub cutaneous injection 0,05 mg/kg/day

Revestive

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being aged from 2 to 18 years old included ;
• Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or having less than 120 cm in case of Short Bowel Syndrome (SBS) caused by Hirschsprung disease;
• Being dependent on PN for at least 2 years and enterally fed (oral or tube feeding) ;
• Having a normal colonoscopy in the 12 months before screening for children with maintained colon (=SBS type 2 or 3) older than 12 years ;
• Having signed the Informed consent form (or parents or legal representative for minor patients).

You may not qualify if:

• Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;
• Having a clinically significant untreated intestinal obstruction or active stenosis ;
• Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ;
• Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;
• Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ;
• Having a history of cancer or clinically significant lymphoproliferative disease; excepted resected cutaneous basal or squamous cell carcinoma, or in situ non-aggressive and surgically resected cancer ;
• Having participated in a clinical study using an experimental drug within 1 month or an experimental antibody treatment within 3 months prior to screening, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide ;
• Having already used native GLP-2 and glucagon-like peptide-1 analog or human growth hormone within 3 months prior to screening ;
• Having already used oral or IV glutamine, octreotide, or dipeptidyl peptidase IV (DPP-IV) inhibitors within 3 months prior to screening ;
• Having an active Crohn's disease which has been treated with biological therapy within the 6 months prior to screening ;
• Having an intestinal polyposis;
• Being, for female patient, both lactating and breast-feeding or having a positive pregnancy test during the screening period;
• Refusing the follow the protocol requirements in terms of birth control ;
• Being unable to follow the study procedures for any reason: psychological, geographical…
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Summary of Product Characteristics (SPC), or trace residues of tetracycline.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Imagine Institute: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker - Enfants malades

Paris, 75015, France

Location

Related Publications (1)

• Lambe C, Talbotec C, Kapel N, Barbot-Trystram L, Brabant S, Nader EA, Pigneur B, Payen E, Goulet O. Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome. Am J Clin Nutr. 2023 Jun;117(6):1152-1163. doi: 10.1016/j.ajcnut.2023.02.019. Epub 2023 May 3.

  PMID: 37270289 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome; Hyperphagia; Intestinal Failure

Interventions

teduglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Olivier GOULET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 19, 2018
• Study Start: July 2, 2018
• Primary Completion: December 11, 2019
• Study Completion: July 13, 2020
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)