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Completed

NCT Number: NCT01968980

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

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.

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Key information

Conditions

Heterozygous Familial Hypercholesterolemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SHAT in Cardiology EAD, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bococizumab (PF-04950615;RN316)

Drug

150 mg every 2 weeks, subcutaneous injection, 12 months

Placebo

Other

subcutaneous injection every 2 weeks for 12 months

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: SPIRE-FH

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2013
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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