Study of ORL-1M (D-mannose) in Patients With CDG-Ib
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|ClinicalTrials.gov Identifier: NCT03404869|
Recruitment Status : Unknown
Verified January 2019 by Orpha Labs.
Recruitment status was: Recruiting
First Posted : January 19, 2018
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|CDG Ib||Drug: ORL-1M - D-mannose||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of ORL-1M (D-mannose) in Patients With CDG-Ib|
|Actual Study Start Date :||March 31, 2015|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||June 1, 2019|
|Treatment with ORL-1M - D-mannose||
Drug: ORL-1M - D-mannose
- Improvement in hypoglycemia, diarrhea and vomiting. [ Time Frame: 6 months after treatment started ]Decreased frequency of hypoglycemic episode, diarrhea and vomiting frequency.
- Improved glycosylation pattern of serum transferrin. [ Time Frame: 30 days after treatment started ]Normalized isoelectric focusing pattern of serum transferrin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404869
|Contact: Study Coordinator Study Coordinator||+90 537 763 email@example.com|
|Ankara, Turkey, 06100|
|Contact: Study Coordinator Study Coordinator +905377636241 firstname.lastname@example.org|