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

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)

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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