WHO ICTRP trial
A clincial study evaluating the safety of the diabetes vaccine Diamyd® in…
EUCTR2014-003755-64-SE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2014-003755-64-SE |
|---|---|
| Public title | A clincial study evaluating the safety of the diabetes vaccine Diamyd® in combination with Vitamin D, and if it can delay or stop the process leading to type 1 diabetes in children at high risk of developing the disease |
| Scientific title | A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® in combination with Vitamin D on the progression to type 1 diabetes in children with multiple islet cell autoantibodies - DiAPREV-IT 2 |
| Primary sponsor | Helena Elding Larsson |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Sweden |
| Conditions | Children with HLA risk and persistent islet autoantibody positivity which is associated with a defined risk for type 1 diabetes;Therapeutic area: Body processes [G] - Immune system processes [G12] |
| Interventions | Product Name: Diamyd Product Code: rhGAD65 formulated in alum (GADalum) Pharmaceutical Form: Suspension for injection INN or Proposed INN: No INN proposed, rhGAD65 formulated in alum (GAD-alum) Other descriptive name: Diamyd Concentration… |
| Registration date | Sep 15, 2014 |
| Target size | 80 |
| Secondary IDs | DiAPREV/2014 |
| 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: