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

Primary Purpose

Short Bowel Syndrome

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apraglutide
Sponsored by
VectivBio AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Short Bowel Syndrome, SBS, Intestinal Failure, SBS-IF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 have completed 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

Sites / Locations

  • Ronald Reagan UCLA Medical CenterRecruiting
  • Henry Ford Health SystemRecruiting
  • Mayo Clinic - RochesterRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Mount Sinai Medical CenterRecruiting
  • Duke University Medical CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of Washington Medical CenterRecruiting
  • University Hospital Fundacion FavaloroRecruiting
  • University Hospital BrusselsRecruiting
  • UZ LeuvenRecruiting
  • University Hospital BrnoRecruiting
  • University Hospital Hradec KraloveRecruiting
  • Hospital Novy JicinRecruiting
  • University Hospital PlzenRecruiting
  • General University Hospital in PragueRecruiting
  • University Hospital Kralovske VinohradyRecruiting
  • Beaujon HospitalRecruiting
  • Nantes University Hospital Center - Hotel Dieu HospitalRecruiting
  • Nice University Hospital Center - Archet 1 HospitalRecruiting
  • Hôpital Haut-LévèqueRecruiting
  • Brabois Adults HospitalRecruiting
  • Charite - University Hospital BerlinRecruiting
  • Asklepios Clinic St. GeorgRecruiting
  • University Hospital HeidelbergRecruiting
  • University Hospital MuensterRecruiting
  • Central Hospital of Northern Pest - Military HospitalRecruiting
  • Semmelweis UniversityRecruiting
  • University of SzegedRecruiting
  • Rambam Health Care Campus, Institute of GastroenterologyRecruiting
  • Chaim Sheba Medical CenterRecruiting
  • Polyclinic S. Orsola-MalpighiRecruiting
  • University Polyclinic Foundation "Agostino Gemelli" - IRCCSRecruiting
  • City of Health and Science of TurinRecruiting
  • Toho University Sakura Medical CenterRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Yokohama Municipal Citizen's HospitalRecruiting
  • Osaka University HospitalRecruiting
  • Tohoku University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • More og Romsdal Hospital Trust - Alesund HospitalRecruiting
  • Stadmedica, Non-Public Healthcare FacilityRecruiting
  • COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for AdultsRecruiting
  • Gastromed Poland Sp. z o.o.Recruiting
  • Stanley Dudrick Multispecialty HospitalRecruiting
  • M. Pirogow Provincial Specialized HospitalRecruiting
  • University General Hospital Gregorio MaranonRecruiting
  • University Hospital 12 de OctubreRecruiting
  • University Hospital Virgen del Rocio (HUVR)Recruiting
  • Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant CentreRecruiting
  • Far Eastern Memorial HospitalRecruiting
  • University College HospitalRecruiting
  • Northern Care Alliance NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apraglutide subcutaneous (SC) injections, once weekly

Arm Description

Peptide analogue of Glucagon-like Peptide 2 (GLP-2)

Outcomes

Primary Outcome Measures

Adverse events (AE)
System organ class, frequency and severity
Clinical chemistry
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Hematology
Hematology panel of analytes will be examined for clinically significant changes.
Hemostasis
Hemostasis INR will be examined for clinically significant changes.
Urinalysis
Urinanalysis panel of analytes will be examined for clinically significant changes.
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.
Occurrence of clinically relevant changes in electrocardiogram
ECG; intervals and rhythm

Secondary Outcome Measures

Change from baseline in PS volume
Change from baseline in PS frequency
Change in PS days/week from baseline to week 104
Clinically significant changes in PS total energy
Units: kcal
Change from baseline in PS infusion time
Percentage of subjects reaching enteral autonomy
Change from baseline in body weight
Units: kg
Change from baseline on the Patient Global Impression of Severity (PGIS)
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
Change from baseline on the Patient Global Impression of Change (PGIC)
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)
Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)
Change from baseline on the Short Form (36) Health Survey (SF-36)
Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)

Full Information

First Posted
July 6, 2021
Last Updated
August 15, 2023
Sponsor
VectivBio AG
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1. Study Identification

Unique Protocol Identification Number
NCT05018286
Brief Title
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
Acronym
STARS extend
Official Title
An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
October 30, 2027 (Anticipated)
Study Completion Date
October 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VectivBio AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Short Bowel Syndrome, SBS, Intestinal Failure, SBS-IF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apraglutide subcutaneous (SC) injections, once weekly
Arm Type
Experimental
Arm Description
Peptide analogue of Glucagon-like Peptide 2 (GLP-2)
Intervention Type
Drug
Intervention Name(s)
Apraglutide
Intervention Description
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
Primary Outcome Measure Information:
Title
Adverse events (AE)
Description
System organ class, frequency and severity
Time Frame
From baseline to week 208
Title
Clinical chemistry
Description
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Time Frame
From baseline to week 208
Title
Hematology
Description
Hematology panel of analytes will be examined for clinically significant changes.
Time Frame
From baseline to week 208
Title
Hemostasis
Description
Hemostasis INR will be examined for clinically significant changes.
Time Frame
From baseline to week 104
Title
Urinalysis
Description
Urinanalysis panel of analytes will be examined for clinically significant changes.
Time Frame
From baseline to week 208
Title
Occurrence of clinically relevant changes in vital signs
Description
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.
Time Frame
From baseline to week 208
Title
Occurrence of clinically relevant changes in electrocardiogram
Description
ECG; intervals and rhythm
Time Frame
From baseline to week 208
Secondary Outcome Measure Information:
Title
Change from baseline in PS volume
Time Frame
From baseline to week 208
Title
Change from baseline in PS frequency
Description
Change in PS days/week from baseline to week 104
Time Frame
From baseline to week 208
Title
Clinically significant changes in PS total energy
Description
Units: kcal
Time Frame
From baseline to week 208
Title
Change from baseline in PS infusion time
Time Frame
From baseline to week 208
Title
Percentage of subjects reaching enteral autonomy
Time Frame
From baseline to week 104
Title
Change from baseline in body weight
Description
Units: kg
Time Frame
From baseline to week 104
Title
Change from baseline on the Patient Global Impression of Severity (PGIS)
Time Frame
From baseline to week 104
Title
Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI)
Time Frame
From baseline to week 208
Title
Change from baseline on the Patient Global Impression of Change (PGIC)
Time Frame
From baseline to week 208
Title
Changes from baseline on Patient Global Impression of Treatment Satisfaction (PGI-TS)
Time Frame
From baseline to week 208
Title
Changes from baseline on Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS)
Time Frame
From baseline to week 208
Title
Changes from baseline on Patient Global Impression of Parenteral Support Impact (PGI-PSI)
Time Frame
From baseline to week 208
Title
Change from baseline on the Short Form (36) Health Survey (SF-36)
Time Frame
From baseline to week 208
Title
Change from baseline on the EuroQoL-5 dimension -5 level survey (EQ-5D-5L)
Time Frame
From baseline to week 208

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahn
Phone
+41615513030
Email
clinicaltrials@vectivbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bolognani
Organizational Affiliation
VectivBio AG
Official's Role
Study Director
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospital Fundacion Favaloro
City
Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
University Hospital Brussels
City
Brussel
ZIP/Postal Code
B-1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Hospital Novy Jicin
City
Nový Jičín
ZIP/Postal Code
741 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Plzen
City
Pilsen
ZIP/Postal Code
30460
Country
Czechia
Individual Site Status
Recruiting
Facility Name
General University Hospital in Prague
City
Prague
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Kralovske Vinohrady
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Beaujon Hospital
City
Clichy
ZIP/Postal Code
92110
Country
France
Individual Site Status
Recruiting
Facility Name
Nantes University Hospital Center - Hotel Dieu Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Nice University Hospital Center - Archet 1 Hospital
City
Nice
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Haut-Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Brabois Adults Hospital
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Name
Charite - University Hospital Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Clinic St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Muenster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Central Hospital of Northern Pest - Military Hospital
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Individual Site Status
Recruiting
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus, Institute of Gastroenterology
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chaim Sheba Medical Center
City
Tel HaShomer
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Polyclinic S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
University Polyclinic Foundation "Agostino Gemelli" - IRCCS
City
Rom
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
City of Health and Science of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Toho University Sakura Medical Center
City
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama Municipal Citizen's Hospital
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-0872
Country
Japan
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
063351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
More og Romsdal Hospital Trust - Alesund Hospital
City
Ålesund
ZIP/Postal Code
6017
Country
Norway
Individual Site Status
Recruiting
Facility Name
Stadmedica, Non-Public Healthcare Facility
City
Bydgoszcz
ZIP/Postal Code
85-391
Country
Poland
Individual Site Status
Recruiting
Facility Name
COPERNICUS Limited Liability Company, Nutrition Outpatient Clinic for Adults
City
Gdańsk
ZIP/Postal Code
80-152
Country
Poland
Individual Site Status
Recruiting
Facility Name
Gastromed Poland Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Stanley Dudrick Multispecialty Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland
Individual Site Status
Recruiting
Facility Name
M. Pirogow Provincial Specialized Hospital
City
Łódź
ZIP/Postal Code
90-531
Country
Poland
Individual Site Status
Recruiting
Facility Name
University General Hospital Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Virgen del Rocio (HUVR)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital, Sahlgrenska Intestinal Failure and Transplant Centre
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Northern Care Alliance NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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