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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354533
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Orpha Labs

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

Condition or disease Intervention/treatment Phase
Leukocyte Adhesion Deficiency, Type II Drug: L-fucose Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Treatment with ORL-1F - L-fucose Drug: L-fucose
Oral ORL-1F




Primary Outcome Measures :
  1. Decrease in infection frequency [ Time Frame: 12 months after treatment started ]
    Statistically significant decrease in infection frequency


Secondary Outcome Measures :
  1. Decrease in neutrophil count [ Time Frame: 30 days after treatment started ]
    Statistically significant decrease in absolute neutrophil count



Information from the National Library of Medicine

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

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.
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Responsible Party: Orpha Labs
ClinicalTrials.gov Identifier: NCT03354533    
Other Study ID Numbers: Ladtwo-1
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: January 25, 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes