WHO ICTRP trial
CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF…
EUCTR2009-011434-10-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2009-011434-10-DE |
|---|---|
| Public title | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES |
| Scientific title | CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES |
| Primary sponsor | OCTAPHARMA AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Germany |
| Conditions | Primary immunodeficiency diseases MedDRA version: 12.0 Level: LLT Classification code 10010112 Term: Common variable immunodeficiency MedDRA version: 12.0 Level: LLT Classification code 10049485 Term: Bruton's agammaglobulinemia |
| Interventions | Product Name: NewGam Product Code: NewGam Pharmaceutical Form: Solution for infusion INN or Proposed INN: immunoglobulin G Other descriptive name: NewGam Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal… |
| Registration date | Oct 27, 2009 |
| Target size | 50 |
| Secondary IDs | NGAM-01 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: