WHO ICTRP trial
Clinical study to find out whether regular infusions of ADVATE in the absence of…
EUCTR2011-000410-18-AT · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2011-000410-18-AT |
|---|---|
| Public title | Clinical study to find out whether regular infusions of ADVATE in the absence of immunological danger signals (eg. tissue damage/viral or bacterial infections) reduces the possibility of inhibitor in PUPs with hemophilia A |
| Scientific title | A PHASE 3b CLINICAL STUDY TO ASSESS WHETHER REGULAR ADMINISTRATION OF ADVATE IN THE ABSENCE OF IMMUNOLOGICAL DANGER SIGNALS REDUCES THE INCIDENCE RATE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH HEMOPHILIA A - EARLY PROPHYLAXIS IMMUNOLOGIC CHALLENGE (EPIC) STUDY |
| Primary sponsor | Baxter Innovations GmbH |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Italy;Switzerland;France;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United… |
| Conditions | Prevention of inhibitor formation, and immune tolerance induction in patients with severe and moderately severe hemophilia A by early and low-dose prophylactic ADVATE therapy;Therapeutic area: Diseases [C] - Blood and lymphatic diseases… |
| Interventions | Trade Name: ADVATE (rAHF-PFM) Product Name: ADVATE (rAHF-PFM) Product Code: not applicable Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: OCTOCOG ALFA CAS Number: 139076-62-3 Concentration unit: IU… |
| Registration date | Mar 31, 2011 |
| Target size | 100 |
| Secondary IDs | 061002 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: