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Therapy for Chronic Cold Agglutinin Disease

NCT00373594 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-06-22

No results posted yet for this study

Summary

Chronic cold agglutinin disease (CAD) is a type of autoimmune hemolytic anemia (anemia due to destruction of red blood cells by abnormal antibodies). Almost all patients also suffer from cold-induced disturbances of blood circulation. The purpose of this study is to assess the efficacy and safety of combination therapy with rituximab (an antibody against B lymphocytes) and fludarabine (a cytotoxic drug) for CAD. Another aim is to try to assess whether these agents in combination are better than single agent therapy with rituximab.

Conditions

  • Cold Agglutinin Disease

Interventions

DRUG

Rituximab

DRUG

Fludarabine

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Principal Investigators

  • Sigbjorn Berentsen, MD, PhD · Haugesund Hospital and University of Bergen

  • Geir E Tjonnfjord, MD, PhD · Rikshospitalet-Radiumhospitalet University Hospital, Oslo

  • Elling Ulvestad, MD, PhD · The Gade Institute, Haukeland University Hospital, Bergen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • Norway
  • Russia

Study Locations

More Related Trials

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 NCT00373594 on ClinicalTrials.gov