Randomized, Double-Blind, Parallel-Group, Adaptive, Three-arm, Phase 2b/3 Multicenter Study to Evaluate the Efficacy and Safety of Zelpultide Alfa in Preventing Bronchopulmonary Dysplasia (BPD) in High-Risk Preterm Neonates Compared to Standard of Care (SOC)

Conditions

prematurity in neonates

Brief summary

Part 1 (Phase 2b / Dose Selection): Incidence of grade 2 or grade 3 BPD or death at week 36 PMA, analyzed descriptively and used for the pre-specified futility assessment., Part 2 (Phase 3 / Confirmatory Phase): Incidence of grade 2 or grade 3 BPD or death at week 36 PMA.

Detailed description

Part 1 (Phase 2b / Dose Selection): Key Secondary Endpoints: Ventilator-free days from birth to week 36 PMA; Incidence of grade 2 or grade 3 BPD or death assessed at 3 consecutive days at week 36 PMA, Additional Efficacy Secondary Endpoints: Incidence of grade 2 or grade 3 BPD at week 36 PMA; Incidence of death at week 36 PMA; The proportion of subjects with no BPD, grade 1, grade 2, or grade 3 BPD at week 36 PMA; The proportion of subjects with no BPD, grade 1, grade 2, or grade 3 BPD assessed at 3 consecutive days at week 36 PMA., Part 2 (Phase 3 / Confirmatory Phase): Key Efficacy Secondary Endpoints: Ventilator-free days from birth to week 36 PMA; Incidence of grade 2 or grade 3 BPD at week 36 PMA; Incidence of death at week 36 PMA; Incidence of grade 2 or grade 3 BPD or death assessed at 3 consecutive days at week 36 PMA.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGEndotracheopulmonary instillation

DRUGroom air

DRUGzelpultide alfa

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Part 1 (Phase 2b / Dose Selection): Incidence of grade 2 or grade 3 BPD or death at week 36 PMA, analyzed descriptively and used for the pre-specified futility assessment., Part 2 (Phase 3 / Confirmatory Phase): Incidence of grade 2 or grade 3 BPD or death at week 36 PMA.	—

Secondary

Measure	Time frame
Part 1 (Phase 2b / Dose Selection): Key Secondary Endpoints: Ventilator-free days from birth to week 36 PMA; Incidence of grade 2 or grade 3 BPD or death assessed at 3 consecutive days at week 36 PMA, Additional Efficacy Secondary Endpoints: Incidence of grade 2 or grade 3 BPD at week 36 PMA; Incidence of death at week 36 PMA; The proportion of subjects with no BPD, grade 1, grade 2, or grade 3 BPD at week 36 PMA; The proportion of subjects with no BPD, grade 1, grade 2, or grade 3 BPD assessed at 3 consecutive days at week 36 PMA., Part 2 (Phase 3 / Confirmatory Phase): Key Efficacy Secondary Endpoints: Ventilator-free days from birth to week 36 PMA; Incidence of grade 2 or grade 3 BPD at week 36 PMA; Incidence of death at week 36 PMA; Incidence of grade 2 or grade 3 BPD or death assessed at 3 consecutive days at week 36 PMA.	—

Measure

Time frame

Part 1 (Phase 2b / Dose Selection): Key Secondary Endpoints: Ventilator-free days from birth to week 36 PMA; Incidence of grade 2 or grade 3 BPD or death assessed at 3 consecutive days at week 36 PMA, Additional Efficacy Secondary Endpoints: Incidence of grade 2 or grade 3 BPD at week 36 PMA; Incidence of death at week 36 PMA; The proportion of subjects with no BPD, grade 1, grade 2, or grade 3 BPD at week 36 PMA; The proportion of subjects with no BPD, grade 1, grade 2, or grade 3 BPD assessed at 3 consecutive days at week 36 PMA., Part 2 (Phase 3 / Confirmatory Phase): Key Efficacy Secondary Endpoints: Ventilator-free days from birth to week 36 PMA; Incidence of grade 2 or grade 3 BPD at week 36 PMA; Incidence of death at week 36 PMA; Incidence of grade 2 or grade 3 BPD or death assessed at 3 consecutive days at week 36 PMA.

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Countries

Italy, Spain

Outcome results

None listed