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NCT01412047 Clinical Trial

Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:
A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01412047
Other study ID # M07-003
Secondary ID
Status Completed
Phase N/A
First received August 5, 2011
Last updated October 16, 2017
Start date March 2012
Est. completion date June 30, 2013

Study information
Verified date October 2017
Source Alexion Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

How does long term treatment with Soliris affect HAHA in PNH patients?

Description:

To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date June 30, 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- PNH patients who previously participated in study E05-001;

- Patients who have an eculizumab naive serum sample for comparison;

- Patients who currently used commerical Soliris;

- Patients who are willing and able to gie written informed consent.

Exclusion Criteria:

- There are no exclusion criteria for this study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Universitatsklinikum Essen Essen
Germany Institut fur Klinische Transfusionmedizin und Immungenetick Ulm
Italy Azienda Ospediliera Universitatia Careggi Firenze
Italy Universita degli Studi di Napoli Napoli
United States University Park Hematology Oncology Englewood Colorado
United States Maine Cancer Center of Medicine Scarborough Maine
United States Cleveland Clinic Florida Weston Florida

Sponsors (1)
Lead Sponsor Collaborator
Alexion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To summarize the proportion of patients with neutralizing HAHA antibodies. Six (6) months
Secondary To summarize the proportion of patients with non-neutralizing HAHA antibodies. Six (6) months
Secondary To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies. Six (6) months
See also
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Recruiting NCT05476887 - To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 Phase 2
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Active, not recruiting NCT06051357 - Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria Phase 2
Recruiting NCT06154512 - A Real-world, Multi-center, Prospective, Observational Study for PNH in China
Completed NCT04128943 - Electronic Patient-reported Outcome Monitoring in Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Active, not recruiting NCT03329365 - Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS
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