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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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)