CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled / 25 target
Drug / intervention
Eculizumabdrug
Likely dose
Eculizumab 600 milligramsfrom 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/NCT05886244
NCT05886244Phase 3CompletedMonitor (0.7/mo)Completion was 14mo ago
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Open-Label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Alexion Pharmaceuticals, Inc.·interventional·Posted Jun 2, 2023·Updated Jun 1, 2026

In Brief

A Phase 3 clinical trial evaluating Eculizumab for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 25 participants across 7 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal hemoglobinuria (PNH) in China.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesChina
CollaboratorsAstraZeneca

Timeline

Phase 3CompletedFinished
202420252026
First PostedJun 2, 2023
Enrollment StartJul 5, 2023
Primary CompletionApr 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.1 years ago

Arms & Interventions

Eculizumabexperimental

Eculizumab will be administered by IV infusion.

Drug: Eculizumab

Interventions

Eculizumabdrug

Participants will receive 600 milligrams (mg) once a week on Day 1, 8, 15, and 22 followed by 900 mg every 2 weeks from Day 29 to Day 435.