WHO ICTRP trial
A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, CHRONIC DOSING (56 WEEK)…
PER-040-14 · Registro Peruano de Ensayos Clínicos (REPEC) · Recruiting
Key facts
| Trial ID | PER-040-14 |
|---|---|
| Public title | A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, CHRONIC DOSING (56 WEEK) PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE, PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 3 DOSES OF BENRALIZUMAB (MEDI-563) IN PATIENTS WITH MODERATE TO VERY SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) WITH A HISTORY OF COPD EXACERBATIONS (TERRANOVA) |
| Scientific title | A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, CHRONIC DOSING (56 WEEK) PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE, PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 3 DOSES OF BENRALIZUMAB (MEDI-563) IN PATIENTS WITH MODERATE TO VERY SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) WITH A… |
| Primary sponsor | ASTRAZENECA PERU S.A., |
| Registry | Registro Peruano de Ensayos Clínicos (REPEC) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | III |
| Countries | Korea South;Turkey;Vietnam;Bulgaria;Spain;France;Italy;United Kindgdom;Russian Federation;Australia;Czech Republic;South Africa;Brazil;Mexico;United States |
| Conditions | -J44 Other chronic obstructive pulmonary disease Other chronic obstructive pulmonary disease;J44 ;Other chronic obstructive pulmonary disease |
| Interventions | Benralizumab 20mg/ml, 30mg/ml, 100 mg/ml y placebo.Good Manufacturing Practice (GMP). Benralizumab and placebo administered in the study will be a clear to opalescent, colourless to yellow solution. Each study subject will receive two… |
| Registration date | Nov 13, 2014 |
| Target size | 167 |
| Registry page | ins.gob.pe |
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: