Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

• Status: Completed
• Trial end date: 2016-12-22
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Antibodies, Monoclonal

Criteria

Key Inclusion Criteria:

1. Prior participation in and the successful completion of the R727-CL-1003 study (NCT01266876).

2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study

3. A negative urine pregnancy at the screening/baseline visit for women of childbearing potential

Key Exclusion Criteria:

1. Reported a drug-related serious adverse event (SAE) or drug-related clinical or laboratory adverse event (AE) in the R727-CL-1003 study that resulted in early termination or withdrawal

2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient

3. Low-density lipoprotein (LDL) apheresis within 12 months before the screening/baseline visit

Note: Other exclusion criteria applied