The effect of Eculizumab on treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 2

Recruiting

• Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH).; Paroxysmal nocturnal hemoglobinuria

• Registration Number: IRCT20150303021315N8
• Lead Sponsor: CinnaGen Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients 18 years of age or older
who had received at least four transfusions during the previous 12 months
Platelet counts of at least 100,000 per cubic millimeter
Lactate dehydrogenase levels that were at least 1.5 times the upper limit of the normal range
Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
PNH(Paroxysmal Nocturnal Haemoglobinuria) diagnosis after flow cytometry and assessment of CD55 and CD59;

Exclusion Criteria

Mean hemoglobin level greater than 10.5 g per deciliter before transfusion during the 12 months before entry into the study
Receiving another investigational drug within 30 days before the first visit
Patients who had a complement deficiency
Active bacterial infection
History of meningococcal disease
Those who had undergone bone marrow transplantation
Pregnant and nursing women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The stabilization of hemoglobin levels, defined as a hemoglobin value that was maintained above the level at which the qualifying transfusion was administered, in the absence of transfusions during the 26-week treatment period. Timepoint: Weekly and then bi-weekly until week 26. Method of measurement: Complete Blood Count (CBC).;The number of units of packed red cells transfused during that period. Timepoint: Weekly and then bi-weekly until week 26. Method of measurement: Calculation.