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Trial record 84 of 157 for:    Idiopathic Dilated Cardiomyopathy

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):
Asahi Kasei Medical Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cardiomyopathy, Dilated
Intervention Device: Mysorba
Enrollment 2
Recruitment Details First site open to enrollment : November 3, 2011 Study terminated: March 22, 2012
Pre-assignment Details 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.
Arm/Group Title IA Treatment
Hide Arm/Group Description The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
due to sponsor closing study             1
Arm/Group Title IA Treatment
Hide Arm/Group Description The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
54.0  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Hide Description [Not Specified]
Time Frame 30 Days Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IA Treatment
Hide Arm/Group Description:
The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of procedure related SAE
0
2.Primary Outcome
Title Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.
Hide Description [Not Specified]
Time Frame 30 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IA Treatment
Hide Arm/Group Description:
The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of device related SAE
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IA Treatment
Hide Arm/Group Description The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
All-Cause Mortality
IA Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IA Treatment
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IA Treatment
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Cardiac disorders   
PVC'S  1/3 (33.33%)  1
Injury, poisoning and procedural complications   
loss of vascular access  1/3 (33.33%)  1
Investigations   
pulse drop  1/3 (33.33%)  2
elevated INR  1/3 (33.33%)  1
Nervous system disorders   
dizzy  1/3 (33.33%)  4
Vascular disorders   
flushing  1/3 (33.33%)  2
hematoma  1/3 (33.33%)  1
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 PI shall provide the sponsor with a copy of any proposed publication for review at least 60 days prior to submission to a publisher. The sponsor may request that any confidential information or intellectual property contained be removed, redacted, or modified. If the PI do not agree to such deletion or modification, they shall notify the sponsor and agree to postpone such submission for an additional 60 days to allow sponsor to file the appropriate applications or seek protective remedies.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Lawrence Winters, MD
Organization: Mayo Clinic
Phone: 507-538-1707
EMail: winters.jeffrey@mayo.edu
Layout table for additonal information
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