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Safety and Tolerability of Repatha in Indian Subjects With Homozygous Familial Hypercholesterolemia

2018-01-24 12:29:11 | BioPortfolio

Summary

To describe the safety and tolerability of Repatha in subjects with homozygous familial hypercholesterolemia (HoFH) in India. All subjects will receive Repatha over an 8 week period.

Description

An open-label, multicentre, phase 4 study to describe the safety and tolerability of Repatha in 30 Indian subjects with HoFH. Subjects who meet the inclusion/exclusion criteria and laboratory assessments at screening will be enrolled and will be required to maintain their current lipid-lowering drug therapy throughout the duration of the trial. Subjects will receive Repatha 420 mg QM SC and study visits will occur approximately every 4 weeks. Apheresis subjects will receive Repatha 420 mg SC every 2 weeks to correspond with their apheresis schedule. Final administration of Repatha (for all subjects) will occur at week 8. The end of study (EOS) visit will occur at week 12 for all subjects.

Study Design

Conditions

Homozygous Familial Hypercholesterolemia HoFH

Intervention

Repatha® (evolocumab)

Status

Not yet recruiting

Source

Amgen

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-01-24T12:29:11-0500

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Medical and Biotech [MESH] Definitions

An autosomal recessive disorder affecting DIHYDROPYRIMIDINE DEHYDROGENASE and causing familial pyrimidinemia. It is characterized by thymine-uraciluria in homozygous deficient patients. Even a partial deficiency in the enzyme leaves individuals at risk for developing severe 5-FLUOROURACIL-associated toxicity.

A group of HEREDITARY AUTOINFLAMMATION DISEASES, characterized by recurrent fever, abdominal pain, headache, rash, PLEURISY; and ARTHRITIS. ORCHITIS; benign MENINGITIS; and AMYLOIDOSIS may also occur. Homozygous or compound heterozygous mutations in marenostrin gene result in autosomal recessive transmission; simple heterozygous, autosomal dominant form of the disease.

Diseases in which there is a familial pattern of AMYLOIDOSIS.

A familial disorder marked by AMYLOID deposits in the walls of small and medium sized blood vessels of CEREBRAL CORTEX and MENINGES.

Familial or idiopathic hypertension in the PULMONARY CIRCULATION which is not secondary to other disease.

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