Status:
COMPLETED
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
Lead Sponsor:
B. Braun Medical Inc.
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurren...
Detailed Description
H.E.L.P. therapy is indicated for use in treating patients with familial hypercholesterolemia (FH) who have undergone six months of optimal diet and drug therapy and whose LDL-C level remains \> 300 m...
Eligibility Criteria
Inclusion
- Adequate venous access
- Laboratory values:
- Hematocrit 30% or greater
- platelet count between 100,000 and 1,000,000/ml
- Premenopausal women must be surgically sterilized or be on oral contraceptive therapy and have a negative pregnancy test at the onset of treatment with H.E.L.P.
- Patients have familial hypercholesterolemia and have undergone at least 6 months optimal diet and drug therapy and fit group A, B, or C
Exclusion
- Presence of any of the following conditions:
- untreated hypothyroidism
- decompensated congestive heart failure
- major arrhythmia
- uncontrolled diabetes mellitus
- any malignancy
- disorders associated with excessive bleeding (e.g., peptic ulcer and hemophilia)
- established or suspected intracranial disease which might cause intracranial bleeding if the patient is anticoagulated
- any other medical disorders which lead the treating physician to believe that H.E.L.P. treatment would not be in the best interest of the patient
- current treatment with anticoagulants
- diastolic BP \> 100 mmHg recorded in two occasions at least 24 hours apart.
- patients under 18 years of age
- positive test for Hepatitis \[Type A (IgM) or B\] antigen, Hepatitis C antibody, or HIV (or diagnosis of AIDS)
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00916643
Start Date
December 1 1999
End Date
September 1 2009
Last Update
April 2 2024
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