NCT03269045 is a Phase 1, PHASE2 clinical trial of ORL-1B in Biotinidase Deficiency, sponsored by Orpha Labs.

Who is sponsoring NCT03269045?

NCT03269045 is sponsored by Orpha Labs.

What drugs are being tested in NCT03269045?

Interventions in NCT03269045: ORL-1B.

What condition does NCT03269045 study?

NCT03269045 studies Biotinidase Deficiency.

Is NCT03269045 still recruiting?

NCT03269045 is currently completed. Last updated 17 January 2018.

Last reviewed 2018-01-17 · How we verify

NCT03269045

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of ORL-1B in Patients With Biotinidase Deficiency

Completed Phase 1, PHASE2 Last updated 17 January 2018

What this trial tests

Phase 1, PHASE2 trial testing ORL-1B in Biotinidase Deficiency in 20 participants. Completed in 1 January 2018.

Timeline

31 August 2013

Primary endpoint
1 January 2018

1 January 2018

Quick facts

Lead sponsor	Orpha Labs
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	31 August 2013
Primary completion	1 January 2018
Estimated completion	1 January 2018

Drugs / interventions tested

ORL-1B — full drug profile →

Conditions studied

Biotinidase Deficiency — all drugs for Biotinidase Deficiency →

Sponsor

Orpha Labs — full company profile →

Who can join

Under 18, any sex, with Biotinidase Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Biotinidase Deficiency

Currently open trials in the same condition.

NCT06723925 — Neonatal Screening of Biotinidase Deficiency: Genotype-phenotype Correlation and Clinical Follow-up · recruiting

Other Orpha Labs trials

Trials by the same sponsor.

NCT03404856 — Study of ORL-1G (D-galactose) in Patients With Glycogen Storage Disease Type 14 · Phase 1, PHASE2 · unknown
NCT03404869 — Study of ORL-1M (D-mannose) in Patients With CDG-Ib · Phase 1, PHASE2 · unknown
NCT03354533 — Study of ORL-1F (L-fucose) in Patients With Leukocyte Adhesion Deficiency Type II · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03269045 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Orpha Labs
Last refreshed: 17 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03269045.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing