Prospective Double-Blind PBO-Controlled Combined Crossover Randomized Withdrawal Study of Latiglutenase in T1D/CD Pts
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Celiac Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: A 2-period, 2-treatment (2x2) crossover and randomized withdrawal design will be used where the treatment sequences will be assigned at random.Masking: Double (Participant, Investigator)Masking Description: The PI, CRA and study biostatistician will be masked until database lock.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 14 years and 80 years
- Gender
- Both males and females
Description
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover with randomized withdrawal study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be schedul...
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover with randomized withdrawal study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.
Tracking Information
- NCT #
- NCT04839575
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Principal Investigator: David Maahs, MD Stanford University
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