Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis (MICA)
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|ClinicalTrials.gov Identifier: NCT01598948|
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : September 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis LDL-hypercholesterolemia||Drug: mipomersen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Mipomersen on LDL-Cholesterol Levels in Patients With Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
Patients randomized to this arm will receive mipomersen 200 mg weekly
mipomersen 200 mg subcutaneously every week for 37 weeks (phase 1: 26 weeks; phase 2: 11 weeks)
No Intervention: Control
patients randomized to this arm will receive no additional drug
- Change in pre-apheresis LDL-cholesterol (phase 1 of the study) [ Time Frame: 6 months ]pre-apheresis LDL-cholesterol concentration will be averaged from 3 subsequent aphereses (exactly 1 week apart) before initiation of mipomersen therapy and after 6 months of weekly apheresis therapy; apheresis conditions will not be changed.
- Fraction of patients in whom apheresis conditions can be modified (phase 2 of the study) [ Time Frame: 3 months ]In phase 2 of the study mipomersen will be given weekly. It will be evaluated in what fraction of patients this results in a decrease of apheresis time, apheresis frequency or stopping of apheresis.
- change in other lipid parameters [ Time Frame: 6 months ]a number of additional lipid parameters will be evaluated before and during mipomersen therapy
- Number of participants with adverse events [ Time Frame: 9 months (phase 1 and 2 of the study) ]
- Plasma concentrations of mipomersen [ Time Frame: 4 days after injection ]pharmacokinetic sampling will be obtained following mipomersen administration at different time points during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598948
|Munich, Germany, 81377|