At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Eculizumab 30 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
In Brief
A Phase 2 clinical trial evaluating Eculizumab for Paroxysmal Nocturnal Hemoglobinuria. Completed, enrolled 27 participants.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Nocturnal Hemoglobinuria
Countries--
CollaboratorsCMIC Co, Ltd. Japan
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
Primary CompletionSep 2010
First PostedSep 2010
Study CompletionMar 2011
TodayJul 2026
First PostedSep 3, 2010
Enrollment StartApr 1, 2008
Primary CompletionSep 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.8 years ago
Interventions
Eculizumabdrug
Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.