NCT03354533

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

6.8 years

First QC Date

November 21, 2017

Last Update Submit

January 22, 2019

Conditions

Leukocyte Adhesion Deficiency, Type II

Outcome Measures

Primary Outcomes (1)

  • Decrease in infection frequency

    Statistically significant decrease in infection frequency

    12 months after treatment started

Secondary Outcomes (1)

  • Decrease in neutrophil count

    30 days after treatment started

Study Arms (1)

Treatment with ORL-1F - L-fucose

OTHER
Drug: L-fucose

Interventions

L-fucoseDRUG

Oral ORL-1F

Treatment with ORL-1F - L-fucose

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Leukocyte Adhesion Deficiency Type II.
  • Less than 18 years old.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Congenital disorder of glycosylation, type 2C

Interventions

Fucose

Intervention Hierarchy (Ancestors)

Deoxy SugarsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 28, 2017

Study Start

January 1, 2012

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share