CompletedNCT03354533Updated Jan 25, 2019

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

A Phase 1/2 interventional study of L-fucose in Leukocyte Adhesion Deficiency, Type II, sponsored by Orpha Labs. Completed. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Orpha Labs · Phase 1/2, Interventional, and Treatment

From the registry’s dates

Registered 5 years 10 months after the study started (first participant enrolled Jan 2012, registered Nov 2017).

Phase: Phase 1/2
Study type: Interventional
Enrollment: 4
Allocation: Not applicable
Ages: Up to 18 Years
Sex: All

Study summary

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

Conditions studied

Leukocyte Adhesion Deficiency, Type II

In context

Lead sponsor

Orpha Labs is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Other
Treatment with ORL-1F - L-fucose
Drug: L-fucose

Interventions

DrugL-fucose
Oral ORL-1F

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2012 to primary completion in Nov 2018, 82 months.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 21, 2017
First posted: Nov 28, 2017
StartActual: Jan 1, 2012
Primary completionActual: Nov 1, 2018
CompletionActual: Nov 1, 2018
Last update: Jan 25, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03354533
Lead sponsor: Orpha Labs
Responsible party: Sponsor
First posted: Nov 28, 2017
Start date: Jan 1, 2012
Primary completion: Nov 1, 2018
Completion: Nov 1, 2018
Last update: Jan 25, 2019

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Fucose

Other studies from this sponsor

Orpha Labs

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