At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 1 enrolled

Drug / intervention

Coversindrug

Likely dose

Coversin 0.57mg/kgfrom 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/NCT02591862

NCT02591862Phase 2Completed

Compare CT.gov

Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms

AKARI Therapeutics·interventional·Posted Oct 30, 2015·Updated Jul 12, 2023

In Brief

A Phase 2 clinical trial evaluating Coversin for Paroxysmal Nocturnal Haemoglobinuria (PNH). Completed, enrolled 1 participant across 1 site.

Detailed Summary

Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsParoxysmal Nocturnal Haemoglobinuria (PNH)

CountriesNetherlands

CollaboratorsRadboud University Medical Center

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

First PostedOct 2015

Enrollment StartFeb 2016

Primary CompletionMar 2018

TodayJul 2026

First PostedOct 30, 2015

Enrollment StartFeb 1, 2016

Primary CompletionMar 20, 2018

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 10.7 years ago

Interventions

Coversindrug

Patients enrolled in this protocol will initially be treated with an ablating dose of Coversin and daily repeat maintenance doses calculated according to body weight, the ablating dose to be 0.57mg/kg. Thereafter the daily repeat dose will be titrated according to clinical response and complement inhibition determined by CH50 ELISA. The initial repeat dose will be 25% of the ablating dose and this will be adjusted up or down if necessary once steady state is reached (5 days).