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Eculizumab in patients with classic PNH: A cost effectivity study.

Conditions
Patient satisfaction, cost effectiveness, Qualtity of life, home-based treatment
Registration Number
NL-OMON29026
Lead Sponsor
Radboud University Nijmegen Medical Centre (RUNMC)
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

1. PNH patients treated with eculizumab;

2. Aged >= 18 years;

Exclusion Criteria

No informed consent.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Satisfaction of patients (home care versus intramural administration) determined by a treatment satisfaction questionnaire.
Secondary Outcome Measures
NameTimeMethod
1. Quality of life (EORTC and Facit Fatigue scale);<br /><br>2. Resource utilisation;<br /><br>3. Indirect costs (productivity losses);<br /><br>4. Utility assessments (EQ-5D);<br /><br>5. Clinical outcomes: safety and sustained reduction of hemolysis;<br /><br>6. Quality control.
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