Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Short Bowel Syndrome Clinical Trial

— STARS extend  

Official title:

An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05018286
• Other study ID #: TA799-012
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 13, 2021
• Est. completion date: October 30, 2027

Study information

• Verified date: January 2024
• Source: VectivBio AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

Description:

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 158
• Est. completion date: October 30, 2027
• Est. primary completion date: October 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013

2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion Criteria:

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.

2. Any other reason judged not eligible by the Investigator.

3. Pregnancy or lactation

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• Apraglutide
Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2

Locations

Country	Name	City	State
Argentina	University Hospital Fundacion Favaloro	Buenos Aires
Belgium	University Hospital Brussels	Brussel
Belgium	UZ Leuven	Leuven
Czechia	University Hospital Brno	Brno
Czechia	University Hospital Hradec Kralove	Hradec Králové
Czechia	Hospital Novy Jicin	Nový Jicín
Czechia	University Hospital Plzen	Pilsen
Czechia	General University Hospital in Prague	Prague
Czechia	University Hospital Kralovske Vinohrady	Praha
Denmark	Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases	Copenhagen
France	Beaujon Hospital	Clichy
France	South Lyon Hospital Center	Lyon
France	Nantes University Hospital Center - Hotel Dieu Hospital	Nantes
France	Nice University Hospital Center - Archet 1 Hospital	Nice
France	Hôpital Haut-Lévèque	Pessac
France	Brabois Adults Hospital	Vandœuvre-lès-Nancy
Germany	Charite - University Hospital Berlin	Berlin
Germany	University Hospital Bonn	Bonn
Germany	Asklepios Clinic St. Georg	Hamburg
Germany	University Hospital Heidelberg	Heidelberg
Germany	University Hospital Muenster	Münster
Hungary	Central Hospital of Northern Pest - Military Hospital	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Szent Imre University Teaching Hospital, Department of Gastroenterology	Budapest
Hungary	University of Szeged	Szeged
Israel	Rambam Health Care Campus, Institute of Gastroenterology	Haifa
Israel	Chaim Sheba Medical Center	Tel HaShomer
Italy	Polyclinic S. Orsola-Malpighi	Bologna
Italy	University Polyclinic Foundation "Agostino Gemelli" - IRCCS	Rome
Italy	City of Health and Science of Turin	Turin
Japan	Yokohama City University Medical Center	Kanagawa
Japan	Yokohama Municipal Citizen's Hospital	Kanagawa
Japan	Osaka University Hospital	Osaka
Japan	Tohoku University Hospital	Sendai
Japan	JCHO Tokyo Yamate Medical Center	Tokyo
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Norway	More og Romsdal Hospital Trust - Alesund Hospital	Ålesund
Poland	Stadmedica, Non-Public Healthcare Facility	Bydgoszcz
Poland	COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults	Gdansk
Poland	M. Pirogow Provincial Specialized Hospital	Lódz
Poland	Gastromed Poland Sp. z o.o.	Lublin
Poland	Stanley Dudrick Multispecialty Hospital	Skawina
Spain	University General Hospital Gregorio Maranon	Madrid
Spain	University Hospital 12 de Octubre	Madrid
Spain	University Hospital Virgen del Rocio (HUVR)	Sevilla
Sweden	Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre	Gothenburg
Taiwan	Far Eastern Memorial Hospital	New Taipei City
United Kingdom	St Mark's Hospital	Harrow
United Kingdom	Royal London Hospital	London
United Kingdom	University College Hospital	London
United Kingdom	Northern Care Alliance NHS Foundation Trust	Salford
United States	Northwestern University - Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VectivBio AG

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AE)	System organ class, frequency and severity	From baseline to week 208
Primary	Clinical chemistry	Clinical Chemistry panel of analytes will be examined for clinically significant changes.	From baseline to week 208
Primary	Hematology	Hematology panel of analytes will be examined for clinically significant changes.	From baseline to week 208
Primary	Hemostasis	Hemostasis INR will be examined for clinically significant changes.	From baseline to week 104
Primary	Urinalysis	Urinanalysis panel of analytes will be examined for clinically significant changes.	From baseline to week 208
Primary	Occurrence of clinically relevant changes in vital signs	Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes.; Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.	From baseline to week 208
Primary	Occurrence of clinically relevant changes in electrocardiogram	ECG; intervals and rhythm	From baseline to week 208
Secondary	Change from baseline in PS volume		From baseline to week 208
Secondary	Change from baseline in PS frequency	Change in PS days/week from baseline to week 104	From baseline to week 208
Secondary	Clinically significant changes in PS total energy	Units: kcal	From baseline to week 208
Secondary	Change from baseline in PS infusion time		From baseline to week 208
Secondary	Percentage of subjects reaching enteral autonomy		From baseline to week 104
Secondary	Change from baseline in body weight	Units: kg	From baseline to week 104
Secondary	Change from baseline on the Patient Global Impression of Severity (PGIS)		From baseline to week 104
Secondary	Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)		From baseline to week 208
Secondary	Change from baseline on the Patient Global Impression of Change (PGIC)		From baseline to week 208
Secondary	Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)		From baseline to week 208
Secondary	Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)		From baseline to week 208
Secondary	Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)		From baseline to week 208
Secondary	Change from baseline on the Short Form (36) Health Survey (SF-36)		From baseline to week 208
Secondary	Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)		From baseline to week 208