WHO ICTRP trial
Clinical research study to assess the safety and effectiveness of…
EUCTR2007-007129-38-IE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2007-007129-38-IE |
|---|---|
| Public title | Clinical research study to assess the safety and effectiveness of alpha1-proteinase inhibitor (A1-PI) administered by intravenous application to patients with alpha1-proteinase deficiency and emphysema who have completed the 2-year treatment and observation period in the Phase III/IV Zemaira® CE1226_4001. |
| Scientific title | An open-label, non-controlled, multicenter, multinational Study to evaluate the Efficacy and Safety of Zemaira® administration in Chronic Augmentation and Maintenance Therapy in Subjects with Emphysema due to Alpha1-Proteinase Inhibitor Deficiency who completed Clinical Study CE1226_4001 |
| Primary sponsor | CSL Behring GmbH |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Estonia;Czech Republic;Canada;Finland;Poland;Ireland;Romania;Denmark;Australia;Germany;Sweden |
| Conditions | Chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema. MedDRA version: 17.0 Level: LLT Classification code 10001811 Term: Alpha-1 proteinase… |
| Interventions | Product Name: Alpha1-Proteinase Inhibitor / Zemaira® Product Code: CE1226 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: There is no recommended INN Current Sponsor code: CE1226 Other descriptive… |
| Registration date | Nov 1, 2008 |
| Target size | 140 |
| Secondary IDs | CE1226_3001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: