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A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia (SPIRE-FH)

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ClinicalTrials.gov Identifier: NCT01968980
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : May 19, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of Bococizumab (PF-04950615; RN316) to lower LDL-C.

Condition or disease Intervention/treatment Phase
Heterozygous Familial Hypercholesterolemia Drug: Bococizumab (PF-04950615;RN316) Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52 Week, Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia
Actual Study Start Date : October 23, 2013
Actual Primary Completion Date : April 15, 2016
Actual Study Completion Date : April 15, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months

Placebo Comparator: Placebo Other: Placebo
subcutaneous injection every 2 weeks for 12 months




Primary Outcome Measures :
  1. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  2. Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  3. Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  4. Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline, Week 12 ]
  5. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  6. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  7. Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  8. Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  9. Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  10. Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  11. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  12. Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  13. Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  14. Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  15. Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  16. Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  17. Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  18. Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  19. Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  20. Absolute Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline, Week 12 ]
  21. Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  22. Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  23. Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  24. Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  25. Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  26. Plasma PF-04950615 Concentrations at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  27. Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: Baseline up to the end of study (up to 58 weeks) ]
    Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.

  28. Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) [ Time Frame: Baseline up to the end of study (up to 58 weeks) ]
    Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated with a statin.
  • Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
  • High or very high risk of incurring a cardiovascular event.
  • Heterozygous familial hypercholesterolemia.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • Poorly controlled hypertension.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968980


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Locations
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United States, California
IMD Medical Group
Los Angeles, California, United States, 90020
United States, Connecticut
Hartford Hospital, JB704
Hartford, Connecticut, United States, 06102
United States, Florida
Best Quality Research, Inc.
Hialeah, Florida, United States, 33016
NewPhase Clinical Trials, Corp.
Miami Beach, Florida, United States, 33140
Medical Research Center
Miami, Florida, United States, 33144
Premier Research Associate, Inc
Miami, Florida, United States, 33165
Columbus Clinical Services, LLC
Miami, Florida, United States, 33174
United States, Nevada
Om Medical
Las Vegas, Nevada, United States, 89119
United States, North Carolina
The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
Chapel Hill, North Carolina, United States, 27599-7075
The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45227
United States, Oklahoma
Oklahoma Heart Hospital Physicians
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
OnSite Clinical Solutions, LLC
Gaffney, South Carolina, United States, 29340
United States, Texas
Galenos Research
Dallas, Texas, United States, 75251
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77099
Pioneer Research Solutions, Inc.
Sugar Land, Texas, United States, 77479
United States, Utah
Focus Clinical Research, LLC
Draper, Utah, United States, 84020
United States, Virginia
Burke Internal Medicine & Research
Burke, Virginia, United States, 22015
Bulgaria
SHAT in Cardiology EAD
Pleven, Bulgaria, 5800
UMHAT "Sveti Georgi" EAD, Clinic of Cardiology
Plovdiv, Bulgaria, 4002
Second MHAT - Sofia EAD
Sofia, Bulgaria, 1202
MHAT "Sveta Anna", Clinic of Internal Diseases
Sofia, Bulgaria, 1709
Canada, British Columbia
St. Paul's Hospital, Healthy Heart
Vancouver, British Columbia, Canada, V6Z 1Y6
Discovery Clinical Services Ltd.
Victoria, British Columbia, Canada, V8T 5G4
Canada, Manitoba
Asper Clinical Research Institute
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Ecogene-21
Chicoutimi, Quebec, Canada, G7H 7K9
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Institut de Recherches Cliniques de Montreal
Montreal, Quebec, Canada, H2W 1R7
Canada
Clinique des maladies lipidiques de Quebec Inc
Quebec, Canada, G1V 4W2
Finland
Helsinki Central University Hospital
Helsinki, Finland, 00014
Pohjois-Karjala Projekti Saatio/Ita-Suomen
Joensuu, Finland, 80100
Pohjois-Karjala Projekti Saatio
Joensuu, Finland, 80100
Laakarikeskus Aava Kerava/Aava Kerava Medical Center
Kerava, Finland, 04200
Oulu University Hospital
Oulu, Finland, 90220
Division of Medicine Turku University Hospital
Turku, Finland, 20520
Italy
Policlinico "Paolo Giaccone"
Palermo, PA, Italy, 90127
Ospedale "Santa Maria della Misericordia"
Perugia, PG, Italy, 06156
Ospedale di Circolo e Fondazione Macchi
Varese, VA, Italy, 21100
Azienda Ospedaliero Universitaria "Federico II" di Napoli
Napoli, Italy, 80131
Netherlands
Admiraal de Ruyter ziekenhuis
Goes, Zeeland, Netherlands, 4462 RA
St. Franciscus Gasthuis
Rotterdam, Zuid-holland, Netherlands, 3045 PM
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Amphia Hospital
Breda, Netherlands, 4818 CK
Hagaziekenhuis
Den Haag, Netherlands, 2545 CH
Deventer Ziekenhuis
Deventer, Netherlands, 7416 SE
Rotterdam Research Institute
Rotterdam, Netherlands, 3039 BD
Albert Schweitzer Hospital
Sliedrecht, Netherlands, 3361 XV
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Norway
Oslo Universitetssykehus HF
Oslo, Norway, 0373
Oslo Universitetssykehus HF, Ulleval
Oslo, Norway, 0450
Poland
NZOZ Vitamed
Bydgoszcz, Poland, 85-079
NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp zo.o.
Krakow, Poland, 31-567
NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki S.C
Ruda Slaska, Poland, 41-709
South Africa
IATROS International
Bloemfontein, Free State, South Africa, 9301
Unitas hospital
Centurion, Gauteng, South Africa, 0157
Midrand Medical Centre
Halfway House, Gauteng, South Africa, 1685
Medipark Centre for Clinical Research
Pretoria, Gauteng, South Africa, 0158
Jongaie Research
Pretoria, Gauteng, South Africa, 0183
Synexus Watermeyer Clinical Research Centre
Pretoria, Gauteng, South Africa, 0184
Roodepoort Medicross Clinical Research Centre
Roodepoort, Gauteng, South Africa, 1724
Chelmsford Medical Centre 3
Durban, Kwa-zulu Natal, South Africa, 4001
Tiervlei Trial Centre, Karl Bremer Hospital
Bellville, Cape Town, Western Cape, South Africa, 7530
TREAD Research cc.
Parow, Cape Town, Western Cape, South Africa, 7500
Synexus Helderberg Clinical Research Centre
Somerset West, Western Cape, South Africa, 7130
Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinico Universitario, Santiago de Compostela
Santiago de Compostela, Galicia, Spain, 15706
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, Spain, 43204
Hospital Clinic
Barcelona, Spain, 08036
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Fundacion Jimenez Diaz; Servicio de Medicina Interna
Madrid, Spain, 28040
Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III
Madrid, Spain, 28040
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Clinico Universitario Miguel Servet; Medicina Interna
Zaragoza, Spain, 50009
United Kingdom
Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy
Manchester, Greater Manchester, United Kingdom, M13 9WL
Pennine Acute Hospitals NHS Trust
Oldham, Greater Manchester, United Kingdom, OL1 2JH
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Burton Hospitals NHS Foundation Trust
Burton-on-Trent, Staffordshire, United Kingdom, DE13 0RB
Heart of England NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B9 5SS
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Peterborough and Stamford Hospitals NHS Foundation Trust
Peterborough, United Kingdom, PE3 9GZ
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01968980     History of Changes
Other Study ID Numbers: B1481021
2013-002644-87 ( EudraCT Number )
SPIRE-HF ( Other Identifier: Alias Study Number )
First Posted: October 24, 2013    Key Record Dates
Results First Posted: May 19, 2017
Last Update Posted: June 26, 2017
Last Verified: May 2017
Keywords provided by Pfizer:
High Risk of cardiovascular events
Heterozygous familial hypercholesterolemia
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Bococizumab
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents