Trial Outcomes & Findings for Immunoadsorption Therapy for Patients With Non-Ischemic Dilated Cardiomyopathy (DCM) (NCT NCT01478087)

NCT ID: NCT01478087

Last Updated: 2013-02-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 30 Days Post Treatment
• Results posted on: 2013-02-15

Participant Flow

First site open to enrollment : November 3, 2011 Study terminated: March 22, 2012

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.

Participant milestones

Measure	IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	IA Treatment The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Overall Study due to sponsor closing study	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	IA Treatment n=3 Participants The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	54.0 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days Post Treatment

Outcome measures

Measure	IA Treatment n=2 Participants The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.	0 percentage of procedure related SAE

PRIMARY outcome

Timeframe: 30 days post-treatment

Outcome measures

Measure	IA Treatment n=2 Participants The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.	0 percentage of device related SAE

Adverse Events

IA Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IA Treatment n=3 participants at risk The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
Investigations pulse drop	33.3% 1/3 • Number of events 2
Cardiac disorders PVC'S	33.3% 1/3 • Number of events 1
Vascular disorders flushing	33.3% 1/3 • Number of events 2
Vascular disorders hematoma	33.3% 1/3 • Number of events 1
Nervous system disorders dizzy	33.3% 1/3 • Number of events 4
Injury, poisoning and procedural complications loss of vascular access	33.3% 1/3 • Number of events 1
Investigations elevated INR	33.3% 1/3 • Number of events 1

Additional Information

Jeffrey Lawrence Winters, MD

Mayo Clinic

Phone: 507-538-1707

Email: winters.jeffrey@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER