CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Eculizumab +1 morebiological
Likely dose
Eculizumab 1200 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/NCT04320602
NCT04320602Phase 4Completed
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Phase 4, Single-Arm Study of Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

Alexion Pharmaceuticals, Inc.·interventional·Posted Mar 25, 2020·Updated Sep 5, 2024

In Brief

A Phase 4 clinical trial evaluating Eculizumab and Ravulizumab for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 18 participants across 4 sites.

Detailed Summary

The primary purpose of this study is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMar 25, 2020
Enrollment StartApr 14, 2021
Primary CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.3 years ago

Interventions

Eculizumabbiological

Participants must have been prescribed and be receiving a stable dose of eculizumab 1200 milligrams (mg) every 2 weeks (q2w) for at least 3 months prior to the Screening Period. During the Screening Period, participants will continue to receive eculizumab 1200 mg q2w.

Ravulizumabbiological

During the Treatment Period, participants will receive a loading dose of ravulizumab on Day 1, followed by maintenance doses on Day 15 and every 8 weeks, administered by intravenous infusion. Ravulizumab loading and maintenance doses will be based on participants' body weight per approved dose regimen.