E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

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Alexion Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Treatments

Drug: Eculizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01194804
E07-001

Details and patient eligibility

About

The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.

Enrollment

27 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients must have fully completed C07-001 study 12-week treatment period

Exclusion criteria

  • Patients who terminated early from the C07-001 study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

Eculizumab
Experimental group
Description:
Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
Treatment:
Drug: Eculizumab

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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