WHO ICTRP trial
A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and…
EUCTR2021-000037-14-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-000037-14-DE |
|---|---|
| Public title | A Global Phase 3 Double-Blind, Placebo-Controlled study to assess Efficacy and Safety of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis |
| Scientific title | A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis |
| Primary sponsor | Prothena Biosciences Limited |
| 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): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;United States;Czechia;Taiwan;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Korea… |
| Conditions | AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and… |
| Interventions | Product Name: Birtamimab Product Code: Birtamimab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: BIRTAMIMAB CAS Number: 1608108-91-3 Current Sponsor code: birtamimab Other descriptive name: Humanized IgG1 kappa… |
| Registration date | May 26, 2021 |
| Target size | 150 |
| Secondary IDs | NEOD001-301;NCT04973137;146070;2021-000037-14-DK |
| Registry page | clinicaltrialsregister.eu |
At a glance
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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: