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Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)

NCT02591862 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-07-12

Study results available
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Summary

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

Conditions

  • Paroxysmal Nocturnal Haemoglobinuria (PNH)

Interventions

DRUG

Coversin

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).

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • AKARI Therapeutics

    lead INDUSTRY

Principal Investigators

  • Petra Dr Muus · Radboud University Medical Center

  • Saskia Dr Langemeijer · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-03-20
Completion
2018-03-20

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02591862 on ClinicalTrials.gov