Know Cancer

or
forgot password

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


N/A
N/A
N/A
Open (Enrolling)
Both
Paroxysmal Nocturnal Hemoglobinuria, PNH

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

To summarize the proportion of patients with neutralizing HAHA antibodies.

Outcome Time Frame:

Six (6) months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

M07-003

NCT ID:

NCT01412047

Start Date:

March 2012

Completion Date:

June 2013

Related Keywords:

  • Paroxysmal Nocturnal Hemoglobinuria
  • PNH
  • Paroxysmal Nocturnal Hemoglobinuria
  • PNH
  • Human Anti-Human Antibody
  • HAHA
  • Soliris
  • eculizumab
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal

Name

Location

Cleveland Clinic FloridaWeston, Florida  33331
Maine Cancer Center of MedicineScarborough, Maine  
University Park Hematology OncologyEnglewood, Colorado  80113