Study of Global Coagulation Tests in Patients With Paroxysmal Nocturnal Haemoglobinuria

NCT ID: NCT01020188

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-08-31

Brief Summary

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Paroxysmal nocturnal haemaoglobinuria (PNH) is a rare disease which results in breakdown of the red blood cells and bone marrow failure. It is associated with an increased risk of blood clots. Until recently, treatment has been with blood transfusions and in patients with a blood clot, blood thinners. A new treatment called eculizumab is now standard for patients who require regular blood transfusions. It works in the majority of patients by preventing the breakdown of red blood cells. This can eliminate the need for blood transfusion and reduce the risk of blood clots. It is not well understood why patients with PNH are at high risk of blood clots. The investigators plan to use specialised blood tests to assess the stickiness of the blood before starting eculizumab treatment and monthly after starting treatment. The investigators will compare these tests with standard tests of clotting.

Detailed Description

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Conditions

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Paroxysmal Nocturnal Haemoglobinuria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Presence of a PNH clone

Exclusion Criteria

* Longterm anticoagulation for previous venous thrombosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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King's College Hospital NHS Foundation Trust

Principal Investigators

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Raj K Patel, MD

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Locations

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King's College Hospital NHS Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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KCH1125

Identifier Type: -

Identifier Source: org_study_id

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