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Trial · Interventional

CompletedPhase 4Registry data

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

Short name REVE

NCTNCT03562130 (opens ClinicalTrials.gov in a new tab)Other idP171002JOther id2017-001405-32Other id2017

Overview

Status
Completed
Phase
Phase 4
Enrollment
25 participants (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

France

Start
2 Jul 2018
Primary completion
11 Dec 2019
Completion
13 Jul 2020
First posted
19 Jun 2018
Last update posted
11 Sept 2025
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 4

    REVE

    NCT03562130

    2 Jul 2018 to 13 Jul 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TeduglutideDrug

Arms1

  • Experimental

    Revestive

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · At week 24

    Registry description

    Evaluate the efficacy of Revestive® treatment

Secondary outcomes(15)
  1. Ostomy output defined as stool balance testing, urine output and plasma citrulline

    Time frame · up to week 48

    Registry description

    Evaluate the impact of Revestive on ostomy flow

  2. Change in days per week of Parenteral Nutrition (PN)

    Time frame · up to week 48

    Registry description

    Quantify the impact of Revestive on the number of perfusion in a week

  3. Change in number of stool per day

    Time frame · up to week 48

    Registry description

    to evaluate the impact of Revestive on diarrhea

  4. Change in stools consistency (Bristol stool chart)

    Time frame · up to week 48

    Registry description

    to evaluate the impact of Revestive on diarrhea

  5. Ingesta (calorimetric measure)

    Time frame · Every 4 weeks up to week 48

    Registry description

    to evaluate the impact of Revestive on Intestinal absorption

  6. Stool weight/24h

    Time frame · Every 4 weeks up to week 48

    Registry description

    to evaluate the impact of Revestive on Intestinal absorption

  7. Percentage of lipid in stool

    Time frame · Every 4 weeks up to week 48

    Registry description

    to evaluate the impact of Revestive on Intestinal absorption

  8. Percentage of nitrogen in stool

    Time frame · Every 4 weeks up to week 48

    Registry description

    to evaluate the impact of Revestive on Intestinal absorption

  9. Percentage of carbohydrate in stool

    Time frame · Every 4 weeks up to week 48

    Registry description

    to evaluate the impact of Revestive on Intestinal absorption

  10. Percentage of sodium in stool

    Time frame · Every 4 weeks up to week 48

    Registry description

    to evaluate the impact of Revestive on Intestinal absorption

  11. Number of adverse events

    Time frame · At week 48

    Registry description

    to evaluate the long term safety of Revestive

  12. Change in body weight

    Time frame · At baseline, then at 6 and 12 months

  13. Change in heart rate

    Time frame · At baseline, then at 6 and 12 months

  14. Change in blood pressure

    Time frame · At baseline, then at 6 and 12 months

  15. Endogenous GLP-2 rates (antibody ELISA)

    Time frame · up to week 48

    Registry description

    to evaluate the response rate of Revestive

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2023

Long-term treatment with teduglutide: a 48-week open-label single-center clinical trial in children with short bowel syndrome.

Lambe et al. 2023The American journal of clinical nutritioncited by 25

PMID 37270289DOI 10.1016/j.ajcnut.2023.02.019PUB-37270289

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ; * 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). Exclusion Criteria: * 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. * Active or suspected malignancy. * Patients with a history of malignancies in the gastrointestinal tract including the hepatobiliary system within the last five years.

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