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AtherosclerosisPhase 3MICANCT01598948

Effect of Mipomersen on LDL-Cholesterol Levels in Patients Treated by Regular Apheresis

A Phase 3 study testing mipomersen in people with Atherosclerosis and LDL-hypercholesterolemia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of disease. In most patients life style modification together with lipid lowering drug therapy is sufficient to achieve this goal. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atherosclerosis, LDL-hypercholesterolemia
What is being tested?
mipomersen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteGermany
Study dates
Aug 2012to Jun 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient fulfils German criteria for regular LDL-apheresis
  • Regular (weekly) LDL-apheresis >/= 3 months
  • The patient has fasting pre-apheresis LDL-C >/= 130 mg/dL at screening.
  • The patient is receiving a stable, maximally tolerated, lipid-lowering regimen
  • The patient has a body mass index (BMI) </= 40 kg/m2 with weight stable (± 4 kg) for > 6 weeks prior to screening.
  • Written informed consent of the patient

Who cannot join

  • The patient has experienced MI, percutaneous transluminal coronary intervention (PTCI), CABG, cerebrovascular accident, unstable angina, or acute coronary syndrome within 12 weeks of screening.
  • The patient has insulin-dependent diabetes mellitus (Type 1), or if Type 2 diabetes, HbA1c > 8% at screening.
  • The patient has New York Heart Association (NYHA) functional classification III or IV heart failure.
  • The patient has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg at screening (despite antihypertensive medication/therapy).
  • The patient has an active infection requiring systemic antiviral or antimicrobial therapy unless treatment expected to be completed by day 1.
  • The patient has a positive test for HIV or hepatitis B or C at screening.
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  • The patient has any uncontrolled condition that may predispose to secondary hyperlipidemia such as uncontrolled hypothyroidism.
  • The patient has had a malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated.
  • The patient has clinically significant hepatic (e.g. History of confirmed non-alcoholic steatohepatitis NASH) or renal disease or Gilbert's syndrome.
  • The patient has previously received mipomersen treatment.
  • The patient is on chronic systemic corticosteroids or anabolic agents except for replacement therapy.
  • The patient has received treatment with another investigational drug, biological agent, or device within 4 weeks of screening or 5 half-lives of the study agent, whichever is longer.
  • The patient has a current or a recent history of drug or alcohol abuse, or unwillingness to limit alcohol consumption to within moderate limits (maximum 20 g alcohol per day and 80 g alcohol per week for males; maximum 10 g alcohol per day and 40 g alcohol per week for females).
  • Patient not able to give consent.
  • Patient without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial.
  • Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
  • Simultaneous participation in another clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to the beginning of the clinical trial.
  • Patient with a physical or psychiatric condition which at the investigator's discretion may put the patient at risk, may confound the trial results, or may interfere with the patient's participation in this clinical trial
  • Known or persistent abuse of medication, drugs or alcohol

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Munich

    Munich, 81377

Other trials in Germany

About this study

Official title: Effect of Mipomersen on LDL-Cholesterol Levels in Patients With Severe LDL-Hypercholesterolemia and Atherosclerosis Treated by Regular LDL-Apheresis

Elevated LDL-cholesterol is a major risk factor for heart disease. In patients with heart disease LDL-cholesterol should be lowered to levels below 70 mg/dl to prevent progression of disease. In most patients life style modification together with lipid lowering drug therapy is sufficient to achieve this goal. In some patients with severe forms of hypercholesterolemia, this may not be sufficient to reach goals and regular lipid apheresis (a costly and time intensive form of therapy) may be performed. Mipomersen is a new drug (apoB antisense oligonucleotide) that can lower LDL-cholesterol even in the most severe forms of LDL-hypercholesterolemia by 25-47%. It is unknown whether and to what extent mipomersen can decrease LDL-cholesterol in patients treated with regular apheresis. Phase 1 of the study will test how 6 months of weekly therapy with mipomersen affects LDL-cholesterol in patients with severe LDL-hypercholesterolemia treated with regular apheresis. Phase 2 will test in how many patients this will result in a meaningful reduction of apheresis time, apheresis frequency or if apheresis can be stopped completely.

Being tested
mipomersen
Keywords
hypercholesterolemia, apheresis, coronary heart disease, cerebrovascular disease, peripheral arterial disease
Medical subject headings
Atherosclerosis, Hypercholesterolemia, Coronary Disease, Cerebrovascular Disorders, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mipomersenDrug

    mipomersen 200 mg subcutaneously every week for 37 weeks (phase 1: 26 weeks; phase 2: 11 weeks)

Study groups in NCT01598948
Study groupRoleWhat they receive
MipomersenExperimentalPatients randomized to this arm will receive mipomersen 200 mg weekly
Receives: Drug: mipomersen
ControlNo interventionpatients randomized to this arm will receive no additional drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pre-apheresis LDL-cholesterol (phase 1 of the study)

    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.

    Measured: 6 months

  2. Fraction of patients in whom apheresis conditions can be modified (phase 2 of the study)

    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.

    Measured: 3 months

Secondary outcomes (3)

  1. change in other lipid parameters

    a number of additional lipid parameters will be evaluated before and during mipomersen therapy

    Measured: 6 months

  2. Number of participants with adverse events

    Measured: 9 months (phase 1 and 2 of the study)

  3. Plasma concentrations of mipomersen

    pharmacokinetic sampling will be obtained following mipomersen administration at different time points during the study.

    Measured: 4 days after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionMay 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01598948
Sponsor's protocol ID
MICA
Acronym
MICA
Status last verified
Sep 2015
First submitted
12 May 2012
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mipomersen in people with Atherosclerosis and LDL-hypercholesterolemia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pre-apheresis LDL-cholesterol (phase 1 of the study) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01598948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.

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