Clinical trial NCT05018286: Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
Official title: An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Short Bowel Syndrome
Keywords: Short Bowel Syndrome
SBS
Intestinal Failure
SBS-IF
Lead sponsor: VectivBio AG
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events (AE)
timeFrame: From baseline to week 208
measure: Clinical chemistry
timeFrame: From baseline to week 208
measure: Hematology
timeFrame: From baseline to week 208
measure: Hemostasis
timeFrame: From baseline to week 104
measure: Urinalysis
timeFrame: From baseline to week 208
measure: Occurrence of clinically relevant changes in vital signs
timeFrame: From baseline to week 208
measure: Occurrence of clinically relevant changes in electrocardiogram
timeFrame: From baseline to week 208
Secondary outcomes:
measure: Change from baseline in PS volume
timeFrame: From baseline to week 208
measure: Change from baseline in PS frequency
timeFrame: From baseline to week 208
measure: Clinically significant changes in PS total energy
timeFrame: From baseline to week 208
measure: Change from baseline in PS infusion time
timeFrame: From baseline to week 208
measure: Percentage of subjects reaching enteral autonomy
timeFrame: From baseline to week 104
measure: Change from baseline in body weight
timeFrame: From baseline to week 104
measure: Change from baseline on the Patient Global Impression of Severity (PGIS)
timeFrame: From baseline to week 104
measure: Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
timeFrame: From baseline to week 208
measure: Change from baseline on the Patient Global Impression of Change (PGIC)
timeFrame: From baseline to week 208
measure: Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
timeFrame: From baseline to week 208
measure: Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)
timeFrame: From baseline to week 208
measure: Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)
timeFrame: From baseline to week 208
measure: Change from baseline on the Short Form (36) Health Survey (SF-36)
timeFrame: From baseline to week 208
measure: Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)
timeFrame: From baseline to week 208
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Chicago
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Buenos Aires
country: Argentina
facility: University Hospital Fundacion Favaloro
city: Brussel
country: Belgium
facility: University Hospital Brussels
city: Leuven
country: Belgium
facility: UZ Leuven
city: Brno
country: Czechia
facility: University Hospital Brno
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
city: Nový Jičín
country: Czechia
facility: Hospital Novy Jicin
city: Pilsen
country: Czechia
facility: University Hospital Plzen
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Praha
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Copenhagen
country: Denmark
facility: Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
city: Clichy
country: France
facility: Beaujon Hospital
city: Lyon
country: France
facility: South Lyon Hospital Center
city: Nantes
country: France
facility: Nantes University Hospital Center - Hotel Dieu Hospital
city: Nice
country: France
facility: Nice University Hospital Center - Archet 1 Hospital
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
city: Vandœuvre-lès-Nancy
country: France
facility: Brabois Adults Hospital
city: Berlin
country: Germany
facility: Charite - University Hospital Berlin
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Hamburg
country: Germany
facility: Asklepios Clinic St. Georg
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Münster
country: Germany
facility: University Hospital Muenster
city: Budapest
country: Hungary
facility: Szent Imre University Teaching Hospital, Department of Gastroenterology
city: Budapest
country: Hungary
facility: Central Hospital of Northern Pest - Military Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Szeged
country: Hungary
facility: University of Szeged
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Institute of Gastroenterology
city: Tel HaShomer
country: Israel
facility: Chaim Sheba Medical Center
city: Bologna
country: Italy
facility: Polyclinic S. Orsola-Malpighi
city: Rome
country: Italy
facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS
city: Turin
country: Italy
facility: City of Health and Science of Turin
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kanagawa
country: Japan
facility: Yokohama Municipal Citizen&#39;s Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Tokyo
country: Japan
facility: JCHO Tokyo Yamate Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ålesund
country: Norway
facility: More og Romsdal Hospital Trust - Alesund Hospital
city: Bydgoszcz
country: Poland
facility: Stadmedica, Non-Public Healthcare Facility
city: Gdańsk
country: Poland
facility: COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
city: Lublin
country: Poland
facility: Gastromed Poland Sp. z o.o.
city: Skawina
country: Poland
facility: Stanley Dudrick Multispecialty Hospital
city: Łódź
country: Poland
facility: M. Pirogow Provincial Specialized Hospital
city: Madrid
country: Spain
facility: University General Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio (HUVR)
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust
Study officials:
affiliation: VectivBio AG
name: Tomasz Masior
role: STUDY_DIRECTOR
References: