CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
ABP 959 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03818607
NCT03818607Phase 3Completed

A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Amgen·interventional·Posted Jan 28, 2019·Updated May 23, 2023

In Brief

A Phase 3 clinical trial evaluating ABP 959 and Eculizumab for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 42 participants across 24 sites in 14 countries.

Detailed Summary

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Finland, France, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 28, 2019
Enrollment StartJan 22, 2019
Primary CompletionJul 12, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.4 years ago

Interventions

ABP 959drug

intravenous infusion

Eculizumabdrug

intravenous infusion