Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II

Overview

Study of ORL-1F in Patients With Leukocyte Adhesion Deficiency Type II

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2018

Interventions

  • Drug: L-fucose
    • Oral ORL-1F

Arms, Groups and Cohorts

  • Other: Treatment with ORL-1F – L-fucose

Clinical Trial Outcome Measures

Primary Measures

  • Decrease in infection frequency
    • Time Frame: 12 months after treatment started
    • Statistically significant decrease in infection frequency

Secondary Measures

  • Decrease in neutrophil count
    • Time Frame: 30 days after treatment started
    • Statistically significant decrease in absolute neutrophil count

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of Leukocyte Adhesion Deficiency Type II. – Less than 18 years old. Exclusion Criteria:

  • Diagnosis of any other disease that is not a manifestation of Leukocyte Adhesion Deficiency Type II.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Orpha Labs
  • Provider of Information About this Clinical Study
    • Sponsor

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