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Trial record 3 of 3 for:    FE 203799

Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support

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ClinicalTrials.gov Identifier: NCT03415594
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Therachon SAS
Information provided by (Responsible Party):
GLyPharma Therapeutic

Brief Summary:
Part A:once weekly dosing for 4 weeks in patients with short bowel syndrome who require total parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they will enter period 2 (active treatment and placebo); Part B: treatment period 3, is an open label extension to part A and starts after a washout of 6-10 weeks after the last dose in treatment period 2. patients are dosed once weekly for 4 weeks.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: FE203799 GLP-2 analogue Drug: FE203799 Placebo GLP-2 analogue Phase 1 Phase 2

Detailed Description:

This trial is divided into 2 parts. Part A of this trial is a repeated dose, placebo controlled, double blind, randomised cross-over trial investigating safety, efficacy and PD of FE 203799 in 8-10 patients with SBS. Additionally, the plasma concentration of FE 203799 will be assessed for determination of the trough and post-dose concentration in SBS patients. The patients will receive a subcutaneous (SC) dose of 5 mg FE 203799 or placebo once weekly for 4 consecutive weeks, and after a washout period of 6-10 weeks, the alternate treatment will be administered once weekly for 4 consecutive weeks. Safety follow-up assessments will be performed 6-10 weeks after the last dose in each treatment period.

Part B of this trial, treatment period 3, is an open label extension to part A that will test a new dose. Following a washout period of 6-10 weeks after the last dose in treatment period 2, the new dose will be administered once weekly for 4 weeks. Safety follow-up assessments will be performed 4-6 weeks after the last dose in treatment period 3.

The first two administrations of trial drug in each treatment period will be performed at the clinic, while the third and fourth dose can be either self-administered by the patient or administered at the clinic if the patient prefers to travel to the site or other considerations make a site visit preferable.

Prior to each administration of trial drug, liver function parameters will be analysed and assessed. During each treatment period, patients who develop extremely high or persistently elevated liver enzymes following trial drug administration will be discontinued from the trial.

The patients will complete a diary during each treatment period with daily data on parenteral support (PS) usage, oral liquid intake at specific periods, trial drug administrations performed at home, local tolerability and adverse events (AEs).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Once-weekly, Repeated Dose, Placebo Controlled, Double Blind, Randomised Cross-over Trial Investigating Safety, Efficacy and Pharmacodynamics of FE 203799 in Patients With Short Bowel Syndrome With Intestinal Failure Requiring Parenteral Support Followed by an Additional Treatment Period in an Open Label Regimen.
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FE203799 5 mg
FE203799 GLP-2 analogue, once weekly, subcutaneous administration
Drug: FE203799 GLP-2 analogue
FE203799 5 mg subQ once weekly

Placebo Comparator: Placebo
Placebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration
Drug: FE203799 Placebo GLP-2 analogue
Placebo subQ once weekly

FE203799 10 mg
FE203799 GLP-2 analogue, once weekly, subcutaneous administration
Drug: FE203799 GLP-2 analogue
FE203799 10 mg subQ once weekly




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Day -28 to Day 29 ]
    Adverse events (AEs) as assessed by CTCAE v4.03


Secondary Outcome Measures :
  1. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 - Day 28 ]
    Measurement of urinary output (ml)

  2. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 - Day 28 ]
    Measurement of urinary sodium (mmol/d)

  3. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 - Day 29 ]
    Measurement of Parenteral Support (L)

  4. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 - Day 28 ]
    Measurement of oral fluids intake (L)

  5. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 and Day 29 ]
    Changes from baseline in lean body mass by DEXA scan

  6. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 and Day 29 ]
    Changes from baseline in fat mass by DEXA scan

  7. Assessment of intestinal failure and gut absorption [ Time Frame: Day -3 and Day 29 ]
    Changes from baseline in bone mineral content by DEXA scan

  8. Assessment of gut regeneration [ Time Frame: Day 1 - Day 29 ]
    Measurements of the plasma citrulline (ng/ml)

  9. Plasma Trough concentration (Ctrough) of study drug [ Time Frame: Day 1 - Day 29 ]
    Ctrough

  10. Plasma concentration post 72 hours (C72) of study drug [ Time Frame: Day 1 - Day 29 ]
    C72



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Males and females with SBS secondary to surgical resection of small intestine
  2. 18-80 years of age
  3. Body Mass Index (BMI) between 16.0 and 32.0
  4. Patients with a jejuno- or ileostomy and a faecal wet weight excretion of at least 1500 g/day, as recorded within the last 18 months according to the patient's medical record
  5. Parenteral support ≥3 times/week for ≥12 months according to the patient's medical record
  6. At least 6 months since last surgical bowel resection
  7. Willing to adhere to a defined oral intake of fluids on certain days as required by the protocol (and based on the individual's routine daily consumption)
  8. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 60 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea and confirmed with follicle-stimulating hormone [FSH] test)

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. Gallstones with subsequent cholecystectomy to resolve the issues is acceptable
  7. Inflammatory bowel disease (IBD) patients 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. Catheter sepsis experienced within the last 3 months
  11. Decompensated heart failure (New York Heart Association [NYHA] class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening
  12. Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue
  13. History of alcohol and/or drug abuse within the last 12 months
  14. 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
  15. Inadequate renal function as defined by serum creatinine or blood urea nitrogen >2.5 × ULN
  16. Unplanned hospitalisation of >24 hours duration within 1 month before the screening visit
  17. Systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab or other biologic therapy/immune modifiers within 30 days of screening
  18. Any use of growth hormone, glutamine or growth factors such as native glucagon-like peptide 2 (GLP 2) or GLP 2 analogue within the last 3 months
  19. Any use of antibiotics within the last 30 days
  20. Participation in another clinical trial within the last 3 months and during this trial
  21. Previously been randomised in this trial
  22. Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening
  23. Patient not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements
  24. For any other reason judged not eligible by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415594


Contacts
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Contact: Nicole Filser, PhD +41786221093 nicole.filser@therachon.com
Contact: Violetta Dimitriadou, PhD 514-876-4220 vdimitriadou@glypharma.com

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Palle Jeppeson, MD         
Sponsors and Collaborators
GLyPharma Therapeutic
Therachon SAS
Investigators
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Principal Investigator: Palle B Jeppeson, MD Department of Gastroenterology CA-2121, Rigshospitalet, Copenhagen, Denmark

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Responsible Party: GLyPharma Therapeutic
ClinicalTrials.gov Identifier: NCT03415594     History of Changes
Other Study ID Numbers: GLY-311-2017
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins