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Therapy of Chronic Cold Agglutinin Disease With Eculizumab

NCT01303952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-07-19

No results posted yet for this study

Summary

Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(CAD)

Conditions

  • Cold Agglutinin Disease

Interventions

DRUG

Eculizumab

Weekly treatment with eculizumab (600 mg) via IV infusion for 4 doses followed the next week by eculizumab (900 mg) IV infusion and maintenance treatment with Eculizumab (900 mg) via IV infusion every other week for 21 weeks

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Alexander Roeth, MD · Department of Hematology, University Hospital Essen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-09-30
Completion
2015-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303952 on ClinicalTrials.gov