Short bowel syndrome (SBS) MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Code: FE 203799
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: None
CAS Number: 1295353-98-8
Curren
Sponsors
GLyPharma Therapeutic Inc. (a wholly owned subsidiary of VectivBio Holding AG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Males and females with SBS-II secondary to surgical resection of the small intestine, with or without an intact colon 2.18-80 years of age 3.Average faecal wet weight excretion of =1500 g/day during the baseline balance study 4.Average urine production =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation 2.Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests 3.A history of clinically significant intestinal adhesions and/or chronic abdominal pain 4.Require chronic systemic narcotics for treatment of pain that exceeds an amount corresponding to 80 mg of morphine per day 5.History of cancer or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer 6.History of gallstone within the past 3 years. Gallstone with subsequent cholecystectomy to resolve the issues is acceptable. 7.Inflammatory bowel disease patients (IBD) who have NOT been on a stable drug treatment regimen for at least the past 4 weeks 8.Evidence of active IBD in the past 12 weeks 9.Visible blood in the stool within the last 3 months 10.Decompensated heart failure (New York Heart Association [NYHA] class III-IV, see Appendix 12.2) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening 11.Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue 12.History of alcohol and/or drug abuse within the last 12 months 13.Inadequate hepatic function as defined by: bilirubin >upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 × ULN; alkaline phosphatase (ALP) >2.5 × ULN; or international normalised ratio (INR) >1.5 × ULN 14.Inadequate renal function as defined by serum creatinine or blood urea nitrogen >2.5 x ULN 15.Unplanned hospitalisation of >24 hours duration within 1 month before the screening visit 16.Changes in systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or other biologic therapy/immune modifiers within 3 months of screening 17.Any use of growth hormone, glutamine or growth factors such as native GLP-2 or GLP-2 analogue within the last 3 months 18.Any use of antibiotics within the last 30 days 19.Participation in another clinical trial (except studies with catheter locks) within the last 3 months and during this trial 20.Previously been treated in this trial 21.Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening 22.Patient not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements 23.For any other reason judged not eligible by the investigator 24. Catheter sepsis experienced within the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of FE 203799 in patients with SBS ; Secondary Objective: •To assess the PD of FE 203799 in patients with SBS •To assess the PK of FE 203799 in patients with SBS with •To compare the PD and PK between SBS patients with intestinal insufficiency (SBS-II) and SBS patients with intestinal failure (SBS-IF) •To evaluate markers indicative of a pharmacological effect of FE 203799 ;Primary end point(s): •Adverse events (AEs; type, frequency and intensity), vital signs (systolic and diastolic blood pressure, heart rate), electrocardiogram (ECG; intervals, rhythm and morphology), clinical chemistry, haematology, haemostasis and urinalysis; Timepoint(s) of evaluation of this end point: From screening visit to end of study, in total during approximately 14 weeks per patients. An AE having onset after the first administration of trial drug is considered treatment emergent. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Changes in faecal excretion of wet weight, energy, macronutrients (carbohydrate, nitrogen as a marker for protein and lipids) and electrolytes (sodium, potassium, calcium and magnesium) over 72 hours from baseline to end of treatment •Changes in urine output and urinary electrolytes (sodium, potassium, calcium and magnesium) over 72 hours from baseline to end of treatment •Changes in dietary intake of wet weight, energy, macronutrients (carbohydrate, nitrogen as a marker for protein and lipids) and electrolytes (sodium, potassium, calcium and magnesium) over 72 hours from baseline to end of treatment •Changes in absolute and relative absorption of wet weight, energy, macronutrients (carbohydrate, nitrogen as a marker for protein and lipids) and electrolytes (sodium, potassium, calcium and magnesium) over 72 hours from baseline to end of treatment •Change in body weight from baseline to end of treatment •Changes from baseline in lean body mass, bone mineral content and fat mass by dual-energy X-ray absorptiometry (DEXA) scan from baseline to end of treatment •Change in plasma citrulline level from baseline to end of treatment •FE 203799 PK parameters: Cmax, Tmax, AUCt, AUCt/dose, ?Z, terminal T½, CL/F, V/F, Fluctuation index ;Timepoint(s) of evaluation of this end point: The secondary efficacy endpoints are all concerned with the change from baseline to the end of treatment for the following parameters: | — |
Countries
Denmark
Contacts
Public ContactChristian Meyer
GLyPharma Therapeutic Inc. (a wholly owned subsidiary of VectivBio Holding AG)
Outcome results
None listed