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OpenTrials
Completed

NCT Number: NCT03354533

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

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

Completed

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Key information

Conditions

Leukocyte Adhesion Deficiency, Type II Congenital disorder of glycosylation, type 2C

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-fucose

Drug

Oral ORL-1F

Primary outcomes

  1. Decrease in infection frequency

    Time frame: 12 months after treatment started

    Statistically significant decrease in infection frequency

Secondary outcomes

  1. Decrease in neutrophil count

    Time frame: 30 days after treatment started

    Statistically significant decrease in absolute neutrophil count

Sponsors and collaborators

Lead sponsor

Orpha Labs

Industry

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2017
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.