WHO ICTRP trial
A non-comparative open pilot trial to assess the safety and pharmacokinetics of…
EUCTR2007-000442-12-FR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2007-000442-12-FR |
|---|---|
| Public title | A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aeruginosa - NA |
| Scientific title | A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aeruginosa - NA |
| Primary sponsor | Kenta Biotech Ltd |
| 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): Therapeutic use (Phase IV): |
| Countries | France;Greece;Belgium |
| Conditions | ventilator associated pneumonia (VAP) caused by serotype O11 Pseudomonas aeruginosa MedDRA version: 9.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia |
| Interventions | Product Name: KBPA-101 (AERUMAB 11) Product Code: KBPA-101 Pharmaceutical Form: Solution for infusion INN or Proposed INN: pacibacumab CAS Number: 885053-97-4 Current Sponsor code: KBPA-101 Other descriptive name: human monoclonal antibody… |
| Registration date | Apr 23, 2007 |
| Target size | 15 |
| Secondary IDs | KB-101-002 |
| 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: