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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)

Primary Purpose

Heterozygous Familial Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bococizumab (PF-04950615;RN316)
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heterozygous Familial Hypercholesterolemia focused on measuring High Risk of cardiovascular events, Heterozygous familial hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IMD Medical Group
  • Hartford Hospital, JB704
  • Best Quality Research, Inc.
  • NewPhase Clinical Trials, Corp.
  • Medical Research Center
  • Premier Research Associate, Inc
  • Columbus Clinical Services, LLC
  • Om Medical
  • The University of North Carolina at Chapel Hill Center for Heart & Vascular Care
  • The University of North Carolina Hospitals - Clinical and Translational Research Center Clinic
  • Metabolic and Atherosclerosis Research Center
  • Oklahoma Heart Hospital Physicians
  • Oklahoma Heart Hospital Research Foundation
  • Oklahoma Heart Hospital
  • Thomas Jefferson University
  • OnSite Clinical Solutions, LLC
  • Galenos Research
  • UT Southwestern Medical Center
  • Pioneer Research Solutions, Inc.
  • Pioneer Research Solutions, Inc.
  • Focus Clinical Research, LLC
  • Burke Internal Medicine & Research
  • SHAT in Cardiology EAD
  • UMHAT "Sveti Georgi" EAD, Clinic of Cardiology
  • Second MHAT - Sofia EAD
  • MHAT "Sveta Anna", Clinic of Internal Diseases
  • St. Paul's Hospital, Healthy Heart
  • Discovery Clinical Services Ltd.
  • Asper Clinical Research Institute
  • Health Sciences Centre
  • University of Ottawa Heart Institute
  • Ecogene-21
  • Montreal Heart Institute
  • Institut de Recherches Cliniques de Montreal
  • Clinique des maladies lipidiques de Quebec Inc
  • Helsinki Central University Hospital
  • Pohjois-Karjala Projekti Saatio/Ita-Suomen
  • Pohjois-Karjala Projekti Saatio
  • Laakarikeskus Aava Kerava/Aava Kerava Medical Center
  • Oulu University Hospital
  • Division of Medicine Turku University Hospital
  • Policlinico "Paolo Giaccone"
  • Ospedale "Santa Maria della Misericordia"
  • Ospedale di Circolo e Fondazione Macchi
  • Azienda Ospedaliero Universitaria "Federico II" di Napoli
  • Admiraal de Ruyter ziekenhuis
  • St. Franciscus Gasthuis
  • Academic Medical Center
  • Amphia Hospital
  • Hagaziekenhuis
  • Deventer Ziekenhuis
  • Rotterdam Research Institute
  • Albert Schweitzer Hospital
  • UMC Utrecht
  • Oslo Universitetssykehus HF
  • Oslo Universitetssykehus HF, Ulleval
  • NZOZ Vitamed
  • NZOZ Centrum Zdrowia i Profilaktyki Dabie Sp zo.o.
  • NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki S.C
  • IATROS International
  • Unitas hospital
  • Midrand Medical Centre
  • Medipark Centre for Clinical Research
  • Jongaie Research
  • Synexus Watermeyer Clinical Research Centre
  • Roodepoort Medicross Clinical Research Centre
  • Chelmsford Medical Centre 3
  • Tiervlei Trial Centre, Karl Bremer Hospital
  • TREAD Research cc.
  • Synexus Helderberg Clinical Research Centre
  • Hospital Universitario de Bellvitge
  • Hospital Clinico Universitario, Santiago de Compostela
  • Hospital Universitario Sant Joan de Reus
  • Hospital Clinic
  • Hospital Universitario Reina Sofia
  • Hospital General Universitario Gregorio Maranon
  • Fundacion Jimenez Diaz; Servicio de Medicina Interna
  • Hospital Clinico San Carlos; U. de Lipidos; Medicina Interna III
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario Miguel Servet; Medicina Interna
  • Clinical Trials Pharmacy, 4th Floor Inpatient Pharmacy
  • Pennine Acute Hospitals NHS Trust
  • East and North Hertfordshire NHS Trust
  • Burton Hospitals NHS Foundation Trust
  • Heart of England NHS Foundation Trust
  • Royal Free London NHS Foundation Trust
  • Central Manchester University Hospitals NHS Foundation Trust
  • Peterborough and Stamford Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bococizumab (PF-04950615;RN316)

Placebo

Arm Description

Bococizumab (PF-04950615;RN316)

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary Outcome Measures

Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Percent Change From Baseline in Lipoprotein (a) at Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12
Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Absolute Change From Baseline in Lipoprotein (a) at Week 12
Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
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
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
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
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.
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
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.

Full Information

First Posted
October 21, 2013
Last Updated
May 31, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01968980
Brief Title
A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
Acronym
SPIRE-FH
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 23, 2013 (Actual)
Primary Completion Date
April 15, 2016 (Actual)
Study Completion Date
April 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolemia
Keywords
High Risk of cardiovascular events, Heterozygous familial hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bococizumab (PF-04950615;RN316)
Arm Type
Experimental
Arm Description
Bococizumab (PF-04950615;RN316)
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bococizumab (PF-04950615;RN316)
Intervention Description
150 mg every 2 weeks, subcutaneous injection, 12 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection every 2 weeks for 12 months
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Cholesterol (TC) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Lipoprotein (a) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52
Time Frame
Baseline, Week 24, 52
Title
Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Time Frame
Baseline, Week 12, 24, 52
Title
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
Title
Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in Lipoprotein (a) at Week 12
Time Frame
Baseline, Week 12
Title
Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame
Baseline, Week 12
Title
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
Title
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
Title
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
Title
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
Title
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Time Frame
Week 12, 24, 52
Title
Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Description
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.
Time Frame
Baseline up to the end of study (up to 58 weeks)
Title
Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Description
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.
Time Frame
Baseline up to the end of study (up to 58 weeks)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35277540
Citation
Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5.
Results Reference
derived
PubMed Identifier
29685591
Citation
Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3.
Results Reference
derived
PubMed Identifier
28304227
Citation
Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481021&StudyName=A%2052%20Week%20Study%20To%20Assess%20The%20Use%20Of%20RN316%20%28PF-04950615%29%20In%20Subjects%20With%20Heterozygous%20Familial%20Hypercholesterolemia
Description
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Learn more about this trial

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

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