Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
- Registration Number
- NCT05018286
- Lead Sponsor
- VectivBio AG
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 158
- 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
- Able to give informed consent and agree to follow the details of participation as outlined in the protocol.
- Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
- Any other reason judged not eligible by the Investigator.
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apraglutide subcutaneous (SC) injections, once weekly Apraglutide Peptide analogue of Glucagon-like Peptide 2 (GLP-2)
- Primary Outcome Measures
Name Time Method Hemostasis From baseline to week 104 Hemostasis INR will be examined for clinically significant changes.
Clinical chemistry From baseline to week 208 Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Urinalysis From baseline to week 208 Urinanalysis panel of analytes will be examined for clinically significant changes.
Adverse events (AE) From baseline to week 208 System organ class, frequency and severity
Hematology From baseline to week 208 Hematology panel of analytes will be examined for clinically significant changes.
Occurrence of clinically relevant changes in vital signs From baseline to week 208 * 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.Occurrence of clinically relevant changes in electrocardiogram From baseline to week 208 ECG; intervals and rhythm
- Secondary Outcome Measures
Name Time Method Change from baseline in body weight From baseline to week 104 Units: kg
Change from baseline on the Patient Global Impression of Severity (PGIS) From baseline to week 104 Change from baseline on the Patient Global Impression of Change (PGIC) From baseline to week 208 Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS) From baseline to week 208 Change from baseline in PS volume From baseline to week 208 Change from baseline in PS frequency From baseline to week 208 Change in PS days/week from baseline to week 104
Clinically significant changes in PS total energy From baseline to week 208 Units: kcal
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) From baseline to week 208 Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) From baseline to week 208 Change from baseline in PS infusion time From baseline to week 208 Percentage of subjects reaching enteral autonomy From baseline to week 104 Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI) From baseline to week 208 Change from baseline on the Short Form (36) Health Survey (SF-36) From baseline to week 208 Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L) From baseline to week 208
Trial Locations
- Locations (66)
Yokohama Municipal Citizen's Hospital
🇯🇵Kanagawa, Japan
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Northwestern University - Chicago
🇺🇸Chicago, Illinois, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University Hospital Fundacion Favaloro
🇦🇷Buenos Aires, Argentina
University Hospital Brussels
🇧🇪Brussel, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
University Hospital Brno
🇨🇿Brno, Czechia
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Czechia
Hospital Novy Jicin
🇨🇿Nový Jičín, Czechia
University Hospital Plzen
🇨🇿Pilsen, Czechia
General University Hospital in Prague
🇨🇿Prague, Czechia
University Hospital Kralovske Vinohrady
🇨🇿Praha, Czechia
Rigshospitalet - University Hospital Copenhagen, Department of Intestinal Failure and Liver Diseases
🇩🇰Copenhagen, Denmark
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, France
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, Germany
Szent Imre University Teaching Hospital, Department of Gastroenterology
🇭🇺Budapest, Hungary
Central Hospital of Northern Pest - Military Hospital
🇭🇺Budapest, Hungary
Semmelweis University
🇭🇺Budapest, Hungary
University of Szeged
🇭🇺Szeged, Hungary
Rambam Health Care Campus, Institute of Gastroenterology
🇮🇱Haifa, Israel
Chaim Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Polyclinic S. Orsola-Malpighi
🇮🇹Bologna, Italy
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
🇮🇹Rome, Italy
City of Health and Science of Turin
🇮🇹Turin, Italy
Yokohama City University Medical Center
🇯🇵Kanagawa, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
JCHO Tokyo Yamate Medical Center
🇯🇵Tokyo, Japan
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, Korea, Republic of
More og Romsdal Hospital Trust - Alesund Hospital
🇳🇴Ålesund, Norway
Stadmedica, Non-Public Healthcare Facility
🇵🇱Bydgoszcz, Poland
COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
🇵🇱Gdańsk, Poland
Gastromed Poland Sp. z o.o.
🇵🇱Lublin, Poland
Stanley Dudrick Multispecialty Hospital
🇵🇱Skawina, Poland
M. Pirogow Provincial Specialized Hospital
🇵🇱Łódź, Poland
University General Hospital Gregorio Maranon
🇪🇸Madrid, Spain
University Hospital 12 de Octubre
🇪🇸Madrid, Spain
University Hospital Virgen del Rocio (HUVR)
🇪🇸Sevilla, Spain
Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
🇸🇪Gothenburg, Sweden
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
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 Kingdom