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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

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE January 1, 2012
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
Decrease in infection frequency [ Time Frame: 12 months after treatment started ]
Statistically significant decrease in infection frequency
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
Decrease in neutrophil count [ Time Frame: 30 days after treatment started ]
Statistically significant decrease in absolute neutrophil count
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II
Official Title  ICMJE Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II
Brief Summary Study of ORL-1F in Patients With Leukocyte Adhesion Deficiency Type II
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukocyte Adhesion Deficiency, Type II
Intervention  ICMJE Drug: L-fucose
Oral ORL-1F
Study Arms  ICMJE Treatment with ORL-1F - L-fucose
Intervention: Drug: L-fucose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2017)
5
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03354533
Other Study ID Numbers  ICMJE Ladtwo-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Orpha Labs
Study Sponsor  ICMJE Orpha Labs
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Orpha Labs
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP