WHO ICTRP trial
Long term follow-up study of gene therapy trial for X-linked Retinitis…
EUCTR2018-000425-31-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-000425-31-GB |
|---|---|
| Public title | Long term follow-up study of gene therapy trial for X-linked Retinitis Pigmentosa |
| Scientific title | Long term follow-up study of participants following an open label, multicentre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5-hRKp.RPGR) for gene therapy of adults and children with X-linked Retinitis Pigmentosa owing to defects in Retinitis Pigmentosa… |
| Primary sponsor | MeiraGTx UK II Ltd |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;United Kingdom |
| Conditions | X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene MedDRA version: 20.0 Level: PT Classification code 10038914 Term: Retinitis pigmentosa System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic… |
| Interventions | Product Name: AAV2/5-hRKp.RPGR Pharmaceutical Form: Solution for injection |
| Registration date | Jun 14, 2018 |
| Target size | 36 |
| Secondary IDs | MGT010 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: