Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 (SAR236553) in Patients With Hypercholesterolemia
This study is ongoing, but not recruiting participants.
Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01576484
First received: March 27, 2012
Last updated: November 9, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is a phase 2, open-label extension study to assess the long-term safety and efficacy of REGN727 (SAR236553) administered by subcutaneous (SC) injection in patients previously participating in the R727-CL-1003 study.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: REGN727 (SAR236553) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Open-Label Extension of Study R727-CL-1003 to Evaluate the Long-Term Safety and Efficacy of REGN727 Administered by Subcutaneous Injection in Patients With Heterozygous Familial Hypercholesterolemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by Regeneron Pharmaceuticals:
Primary Outcome Measures:
- Incidence of AEs from baseline to end of study [ Time Frame: Baseline (Day 1) to week 218 (End of study) ] [ Designated as safety issue: Yes ]Incidence of AEs from baseline (Day 1) to week 218 (end of study)
Secondary Outcome Measures:
- Percent change in LDL-C: Baseline to weeks 12, 24, 52 and 218 [ Time Frame: Baseline (Day 1) to weeks 12, 24, 52 and 218 (End of study) ] [ Designated as safety issue: No ]Percent change in calculated serum LDL-C (Low-density lipoprotein cholesterol) from baseline (average of values calculated at Screening Visit and Baseline [Day 1] visits) in the current study to weeks 12, 24, 52 and 218.
- Changes in other lipids and other lipoproteins [ Time Frame: Baseline (Day 1) and week 218 (End of study) ] [ Designated as safety issue: No ]To evaluate the effect of REGN727 on other lipid parameters.
| Enrollment: | 54 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open Label |
Drug: REGN727 (SAR236553)
REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Key Inclusion Criteria
- Prior participation in and the successful completion of the R727-CL-1003 study.
- Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study
- A negative urine pregnancy at the screening/baseline visit for women of childbearing potential
Exclusion Criteria:
Key Exclusion Criteria
- Reported a drug-related SAE or drug-related clinical or laboratory AE in the R727-CL-1003 study that resulted in early termination or withdrawal
- Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient
- LDL apheresis within 12 months before the screening/baseline visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576484
Locations
| United States, California | |
| Mission Viejo, California, United States | |
| Newport Beach, California, United States | |
| Westlake Village, California, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| Port Orange, Florida, United States | |
| United States, Kansas | |
| Kansas City, Kansas, United States | |
| United States, Maine | |
| Auburn, Maine, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| United States, Ohio | |
| Cincinnatti, Ohio, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| Canada, Quebec | |
| Chicoutimi, Quebec, Canada | |
| Montreal, Quebec, Canada | |
| Canada | |
| Quebec, Canada | |
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01576484 History of Changes |
| Other Study ID Numbers: | R727-CL-1032 |
| Study First Received: | March 27, 2012 |
| Last Updated: | November 9, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
ClinicalTrials.gov processed this record on May 16, 2013