Study of ORL-1M (D-mannose) in Patients With CDG-Ib

CDG Ib Clinical Trial

Official title:

Study of ORL-1M (D-mannose) in Patients With CDG-Ib

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404869
• Other study ID #: PMID-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 31, 2015
• Est. completion date: June 1, 2019

Study information

• Verified date: January 2019
• Source: Orpha Labs
• Contact: Study Coordinator Study Coordinator
• Phone: +90 537 763 6241
• Email: business.development[@]orphalabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study of ORL-1M in Patients With CDG-Ib

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of CGD-1b.

• Less than 18 years old.

Exclusion Criteria:

• Diagnosis of any other disease that is not a manifestation of CGD-1b.

Related Conditions & MeSH terms

• CDG Ib

Intervention

Drug:
• ORL-1M - D-mannose
Oral ORL-1M

Locations

Country	Name	City	State
Turkey	Orpha Labs	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Orpha Labs

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in hypoglycemia, diarrhea and vomiting.	Decreased frequency of hypoglycemic episode, diarrhea and vomiting frequency.	6 months after treatment started
Secondary	Improved glycosylation pattern of serum transferrin.	Normalized isoelectric focusing pattern of serum transferrin.	30 days after treatment started