WHO ICTRP trial
A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to…
NL-OMON55372 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting
Key facts
| Trial ID | NL-OMON55372 |
|---|---|
| Public title | A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of *Kamada-AAT for Inhalation* 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% <= FEV1 <= 80% of predicted; FEV1/SVC <= 70%) |
| Scientific title | A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of *Kamada-AAT for Inhalation* 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% <= FEV1 <= 80% of predicted… |
| Primary sponsor | Kamada Ltd. |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Belgium;Finland;Ireland;Netherlands;Sweden;United Kingdom |
| Conditions | AATD congenital lung disease;10010613 |
| Interventions | Active Product: Alpha-1 Proteinase Inhibitor (Alpha-1 Antitrypsin) (human A1PI) Dosage form: Nebulizer solution 2% AAT Dosage frequency: Once daily preferably in the afternoon/evening Mode of Administration: Inhalation using the eFlow… |
| Registration date | May 15, 2019 |
| Target size | 70 |
| Secondary IDs | 2019-000602-30;NL69564.058.19 |
| Registry page | onderzoekmetmensen.nl |
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: