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COMPLETED Phase 3

Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)

NCT00122317 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • DRUG eculizumab

Study Locations (20)

Maryland

  • Johns Hopkins University Medical Center — Baltimore
  • National Heart, Lung, and Blood Institute, National Institutes of Health — Bethesda

New York

  • NYU Clinical Cancer Center — New York
  • Memorial Sloan Kettering Cancer Center — New York

Other

  • Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology — Parkville
  • Ucl St. Luc, Hematology Department — Brussels

California

  • Stanford University Medical Center, Division of Hematology — Stanford

Connecticut

  • Hartford Hospital, Cancer Clinical Research Office — Hartford

Florida

  • Cleveland Clinic Florida, Department of Clinical Research — Weston

Indiana

  • Indianapolis University Cancer Center — Indianapolis

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 187 participants
Start Date 2005-05
Est. Completion 2008-10
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00122317

The ClinicalTrials.gov registry entry for NCT00122317 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Paroxysmal Hemoglobinuria, Nocturnal appearing as the primary indexed condition, and to 1 intervention — of which eculizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00122317 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Maryland, New York, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00122317 about?

NCT00122317 is a clinical study titled "Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH)". The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

What is the current status of trial NCT00122317?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 187 participants. The study started on 2005-05. Estimated completion is 2008-10.

What conditions does trial NCT00122317 study?

This clinical trial studies the following conditions: Paroxysmal Hemoglobinuria, Nocturnal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00122317?

The interventions under investigation include: eculizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00122317?

This trial is sponsored by Alexion Pharmaceuticals, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00122317 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial