CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 187 enrolled
Drug / intervention
eculizumabdrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Completion of TRIUMPH, SHEPHERD, or X03-001 study
  • ✓TRIUMPH patients who discontinued investigational drug prior to final visit due to lack of efficacy or worsening PNH symptoms and completed all monthly safety/efficacy procedures
  • ✓Written informed consent
  • ✓Commitment to avoid conception during trial
Key exclusion· 4
  • ✕Early termination from SHEPHERD or X03-001 studies
  • ✕Early termination from TRIUMPH due to adverse event
  • ✕Pregnancy, breast feeding, or intention to conceive during study
  • ✕Any condition increasing risk or confounding study outcome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00122317
NCT00122317Phase 3Completed
CompareCT.gov

Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH

Alexion Pharmaceuticals, Inc.·interventional·Posted Jul 22, 2005·Updated Mar 13, 2018

In Brief

A Phase 3 clinical trial evaluating eculizumab for Paroxysmal Hemoglobinuria, Nocturnal. Completed, enrolled 187 participants across 40 sites in 12 countries.

Detailed Summary

The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParoxysmal Hemoglobinuria, Nocturnal
CountriesAustralia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2005
Enrollment StartMay 1, 2005
Primary CompletionSep 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.9 years ago

Interventions

eculizumabdrug