WHO ICTRP trial
STUDY OF ORGN001 IN NEWBORNS, INFANTS AND CHILDREN WITH MOLYBDENUM COFACTOR…
EUCTR2013-002702-30-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2013-002702-30-GB |
|---|---|
| Public title | STUDY OF ORGN001 IN NEWBORNS, INFANTS AND CHILDREN WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A |
| Scientific title | A PHASE 2/3, MULTICENTER, MULTINATIONAL, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORGN001 (formerly ALXN1101) IN NEONATES, INFANTS, AND CHILDREN WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A |
| Primary sponsor | Origin Biosciences, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;United States;Saudi Arabia;Argentina;Spain;Turkey;Israel;Germany;Italy;United Kingdom |
| Conditions | Molydenum CoFactor Deficiency (MoCD) Type A MedDRA version: 20.1 Level: PT Classification code 10069687 Term: Molybdenum cofactor deficiency System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area… |
| Interventions | Product Name: Cyclic Pyranopterin Monophosphate Monohydrobromide Dihydrate Product Code: ORGN001 (formerly ALXN1101) Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Cyclic pyranopterin monophosphate… |
| Registration date | Oct 11, 2015 |
| Target size | 10 |
| Secondary IDs | ALXN1101-MCD-202;NCT02629393;2013-002702-30-DE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: