NCT02598583

Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

An Open-Label, Intrapatient, Dose-Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple intravenous (IV) doses of ALXN1210 administered to participants with PNH who have not previously been treated with complement inhibitor.

Detailed description

The data presented is up to the Primary Completion date of the study and is for the 24-week Primary Evaluation period. The study also includes an Extension Period of up to 5 years.

Conditions

• PNH

Interventions

Type	Name	Description
BIOLOGICAL	ALXN1210	Participants were administered ravulizumab as an IV infusion every 4 weeks.

Timeline

• Start date: 2015-11-12
• Primary completion: 2016-07-14
• Completion: 2021-03-11
• First posted: 2015-11-06
• Last updated: 2022-05-16
• Results posted: 2018-01-30

Locations

8 sites across 2 countries: Australia, South Korea