WHO ICTRP trial
Clinical study to assess the efficacy and safety of gene therapy for the…
EUCTR2019-000331-63-NL · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2019-000331-63-NL |
|---|---|
| Public title | Clinical study to assess the efficacy and safety of gene therapy for the treatment of Sickle Cell Disease |
| Scientific title | A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease. |
| Primary sponsor | bluebird bio, Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;France;Germany;Netherlands;United Kingdom;Italy |
| Conditions | Sickle Cell Disease MedDRA version: 21.0 Level: PT Classification code 10040644 Term: Sickle cell disease System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic… |
| Interventions | Product Name: LentiGlobin BB305 Drug Product for Sickle Cell Disease (also known as bb1111) Pharmaceutical Form: Dispersion for infusion INN or Proposed INN: Not Applicable Other descriptive name: AUTOLOGOUS CD34+ CELLS TRANSDUCED WITH… |
| Registration date | Nov 13, 2020 |
| Target size | 35 |
| Secondary IDs | HGB-210;2019-000331-63-GB |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: