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Therapy of Chronic Cold Agglutinin Disease With Eculizumab (DECADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303952
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Alexander Roeth, MD, University Hospital, Essen

Tracking Information
First Submitted Date  ICMJE February 24, 2011
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date July 19, 2017
Actual Study Start Date  ICMJE January 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
LDH [ Time Frame: From baseline to 26 weeks ]
Primary endpoint for this study is: lactate dehydrogenase (LDH) in U/l change from baseline to 26 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
  • Transfusion avoidance [ Time Frame: From baseline to 26 weeks ]
  • PRBC units transfused [ Time Frame: From baseline to 26 weeks ]
  • Change in hemoglobin levels [ Time Frame: From baseline to 26 weeks ]
  • Haptoglobin [ Time Frame: From baseline to 26 weeks ]
  • Hemopexin [ Time Frame: From baseline to 26 weeks ]
  • Free hemoglobin [ Time Frame: From baseline to 26 weeks ]
  • Reticulocytes [ Time Frame: From baseline to 26 weeks ]
  • SF-36v2 QLQ [ Time Frame: From baseline to 26 weeks ]
  • FACIT-F SCALE version 4 [ Time Frame: From baseline to 26 weeks ]
  • Six-Minute Walk Test [ Time Frame: From baseline to 26 weeks ]
  • Circulatory symptoms [ Time Frame: From baseline to 26 weeks ]
  • Thrombosis record [ Time Frame: From baseline to 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapy of Chronic Cold Agglutinin Disease With Eculizumab
Official Title  ICMJE Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab
Brief Summary Evaluation of the efficacy and safety of eculizumab in symptomatic or transfusion-dependent patients with untreated or refractory hemolytic cold agglutinin disease(CAD)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cold Agglutinin Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Eculizumab
Intervention: Drug: Eculizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
15
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals at least 18 years of age
  • Diagnosis of CAD defined by the combination of chronic hemolysis, cold agglutinin titer (IgM or IgA) >64 at 4°C, positive direct antiglobulin test (DAT) when performed with polyspecific antiserum, negative (or only weakly positive) anti-IgG, and strongly positive with anti-C3d
  • LDH level > 2 x upper limit of normal (ULN)
  • Clinical symptoms requiring treatment, such as anemia, anemia-related symptoms or hemolysis-related symptoms
  • Sufficient supplementation of iron, folic acid and vitamin B12 prior to treatment phase
  • Patient must be willing and able to give written informed consent;
  • Patients must be vaccinated against N. meningitidis at least 14 days prior treatment
  • Patient must avoid conception during the trial using a method that is most appropriate for their physical state and culture

Exclusion Criteria:

  • Active aggressive lymphoma requiring therapy or an active non-lymphatic malignant disease other than basal cell carcinoma or CIS of the cervix
  • Liver disease with elevated LDH
  • Absolute neutrophil count < 500/µL
  • Presence or suspicion of active bacterial or viral infection, in the opinion of the Investigator, at treatment start or severe recurrent bacterial infections
  • Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period
  • Pregnant, breast-feeding, or intending to conceive during the course of the study, including the Post-treatment Phase
  • History of bone marrow/stem cell transplantation
  • Inability to cooperate or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
  • Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303952
Other Study ID Numbers  ICMJE CAD01
2009-016966-97 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexander Roeth, MD, University Hospital, Essen
Study Sponsor  ICMJE University Hospital, Essen
Collaborators  ICMJE Alexion Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Alexander Roeth, MD Department of Hematology, University Hospital Essen
PRS Account University Hospital, Essen
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP