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Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM)

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: NCT01478087
Recruitment Status : Terminated (Sponsor terminated due to business reasons)
First Posted : November 23, 2011
Results First Posted : February 11, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cardiomyopathy, Dilated
Intervention: Device: Mysorba

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First site open to enrollment : November 3, 2011 Study terminated: March 22, 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three (3) subjects enrolled, 2 completed treatment through six-month follow up. One (1) subject terminated participation prior to treatment due to sponsor stopping the study.

Reporting Groups
  Description
IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

Participant Flow:   Overall Study
    IA Treatment
STARTED   3 
COMPLETED   2 
NOT COMPLETED   1 
due to sponsor closing study                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.

Baseline Measures
   IA Treatment 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.0  (6.3) 
Gender 
[Units: Participants]
 
Female   1 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures

1.  Primary:   Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.   [ Time Frame: 30 Days Post Treatment ]

2.  Primary:   Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.   [ Time Frame: 30 days post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jeffrey Lawrence Winters, MD
Organization: Mayo Clinic
phone: 507-538-1707
e-mail: winters.jeffrey@mayo.edu



Responsible Party: Asahi Kasei Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01478087     History of Changes
Other Study ID Numbers: AMA-2011DCM Pilot Study
First Submitted: November 7, 2011
First Posted: November 23, 2011
Results First Submitted: January 8, 2013
Results First Posted: February 11, 2013
Last Update Posted: February 15, 2013