ong-term safety of apraglutide in short bowel syndrome
- Conditions
- short bowel syndromeMedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-005513-41-IT
- Lead Sponsor
- VectivBio AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 154
1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with CIC or stoma, who have completed parent trials TA799-007 or TA799-013 and:
a. Did not meet any stopping criteria.
b. Received a minimum of 70% of the planned doses in the trial (unless an AE precluded the subject from meeting this percentage; in this case, the Investigator will decide if the subject will benefit from enrolling in the trial).
c. Complete the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, COVID-19 pandemic, or emergency surgery) which resulted in several consecutive missed doses may be eligible to participate in this
trial upon approval by the Medical Monitor.
2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol.
3. Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for 4 weeks after the end of trial (EOT) visit.
4. Male subjects with a female partner of childbearing potential must commit to practice methods of contraception and abstain from sperm donation during the trial and for 2 weeks after the EOT Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess long-term safety and tolerability of apraglutide in subjects with SBS-IF;Secondary Objective: To evaluate markers indicative of clinical effects of apraglutide;Primary end point(s): - Adverse events (AE; system organ class, frequency and severity)<br>- Occurrence of clinically relevant AEs of special interest (AESIs):<br>o Injection site reactions<br>o Gastrointestinal (GI) obstructions<br>o Gallbladder, biliary and pancreatic disease<br>o Fluid overload<br>o Colorectal polyps<br>o Malignancies<br>- Clinical chemistry, hematology, hemostasis and urinalysis<br>- Occurrence of clinically relevant changes in vital signs (systolic and diastolic blood pressure, heart rate)<br>- Occurrence of clinically relevant changes in electrocardiogram (ECG; intervals and rhythm);Timepoint(s) of evaluation of this end point: week 104
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline in PS volume at Week 104<br>- Change from baseline in PS frequency at Week 104<br>- Change from baseline in PS composition at Week 104<br>- Change from baseline in PS infusion time at Week 104<br>- Percentage of subjects reaching enteral autonomy by Week 104<br>- Change from baseline in body weight at Week 104<br>- Change from baseline on QoL measures at Week 104;Timepoint(s) of evaluation of this end point: week 104