Status:
WITHDRAWN
Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation
Lead Sponsor:
Anelixis Therapeutics, LLC
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.
Detailed Description
This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant. This study will also provide va...
Eligibility Criteria
Inclusion
- Men and women 18-65 years of age
- A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age
- Involvement in intensive diabetes management as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of severe hypoglycemia
- At least 2 unexplained SHEs not secondary to a missed meal or dosing error, etc., in the 12 months prior to Screening
- Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
- Absence of stimulated C peptide (\< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption
- Reduced awareness of hypoglycemia as defined by a Clarke Score \[Clarke 1995\] of 4 or more at the time of Screening, during the Screening period and within the last 6 months prior to the transplant
Exclusion
- Any previous transplant
- HbA1c level less than 7% (53 mmol/mol)
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04711226
Start Date
February 19 2021
End Date
June 1 2026
Last Update
August 10 2022
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1