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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

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE October 24, 2013
Results First Submitted Date  ICMJE April 7, 2017
Results First Posted Date  ICMJE May 19, 2017
Last Update Posted Date June 26, 2017
Actual Study Start Date  ICMJE October 23, 2013
Actual Primary Completion Date April 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: 12 weeks ]
Low Density Lipoprotein (LDL) cholesterol blood concentrations
Change History Complete list of historical versions of study NCT01968980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • Percent Change From Baseline in Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52 [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • 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 ]
  • Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Lipoprotein (a) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Plasma PF-04950615 Concentrations at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: 12 weeks ]
    Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Triglycerides, TC/HDL and ApoB/ApoA-I ratio.
  • Change from Baseline in Lipid Parameters at Week 24 [ Time Frame: 24 weeks ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Triglycerides, TC/HDL and ApoB/ApoA-I ratio.
  • Change from Baseline in Lipid Parameters at Week 52 [ Time Frame: 52 weeks ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Triglycerides, TC/HDL and ApoB/ApoA-I ratio.
  • Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL [ Time Frame: 12 weeks ]
    Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL
  • Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL [ Time Frame: 24 weeks ]
    Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL
  • Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL [ Time Frame: 52 weeks ]
    Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL
  • Plasma PF-04950615 concentration [ Time Frame: 12 weeks ]
    Plasma PF-04950615 concentration
  • Plasma PF-04950615 concentration [ Time Frame: 24 weeks ]
    Plasma PF-04950615 concentration
  • Plasma PF-04950615 concentration [ Time Frame: 52 weeks ]
    Plasma PF-04950615 concentration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heterozygous Familial Hypercholesterolemia
Intervention  ICMJE
  • Drug: Bococizumab (PF-04950615;RN316)
    150 mg every 2 weeks, subcutaneous injection, 12 months
  • Other: Placebo
    subcutaneous injection every 2 weeks for 12 months
Study Arms  ICMJE
  • Experimental: Bococizumab (PF-04950615;RN316)
    Bococizumab (PF-04950615;RN316)
    Intervention: Drug: Bococizumab (PF-04950615;RN316)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2016)
370
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
300
Actual Study Completion Date  ICMJE April 15, 2016
Actual Primary Completion Date April 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Finland,   Italy,   Netherlands,   Norway,   Poland,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01968980
Other Study ID Numbers  ICMJE B1481021
2013-002644-87 ( EudraCT Number )
SPIRE-HF ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP