PF-06741086 Multiple Dose Study in Severe Hemophilia

November 15, 2019 updated by: Pfizer

A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous and/or intravenous doses of PF-06741086 in subjects with severe hemophilia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 8207257
        • Hospital Dr. Sotero del Rio
  • Croatia
      • Zagreb, Croatia, 10000
        • Klinicki bolnicki centar Zagreb
  • Poland
      • Gdansk, Poland, 80-952
        • Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
  • South Africa
    • Eastern CAPE
      • Port Elizabeth, Eastern CAPE, South Africa, 6001
        • Phoenix Pharma (Pty) Ltd
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Haemophilia Comprehensive Care Centre
  • Switzerland
      • Zurich, Switzerland, 8091
        • UniversitatsSpital Zurich, Klinik fur Hamatologie
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • UC Denver Hemophilia and Thrombosis Center - Pharmacy
      • Aurora, Colorado, United States, 80045
        • UC Denver Hemophilia and Thrombosis Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612
        • Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%), including patients with inhibitors to Factor VIII or Factor IX
  • Episodic (on-demand) treatment regimen prior to screening
  • At least 6 acute bleeding episodes during the 6-month period prior to screening

Exclusion Criteria:

  • Known coronary artery, thrombotic, or ischemic disease
  • Currently receiving treatment for acute bleeding episodes with APCC and cannot substitute treatment with rFVIIa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PF-06741086 (Cohort 1)
Biological: PF-06741086
PF-06741086 subcutaneous (SC) injection
Biological: PF-06741086
PF-06741086 SC injection
Experimental: PF-06741086 (Cohort 2)
Biological: PF-06741086
PF-06741086 subcutaneous (SC) injection
Biological: PF-06741086
PF-06741086 SC injection
Experimental: PF-06741086 (Cohort 3)
Biological: PF-06741086
PF-06741086 subcutaneous (SC) injection
Biological: PF-06741086
PF-06741086 SC injection
Experimental: PF-06741086 (Cohort 4)
Biological: PF-06741086
PF-06741086 subcutaneous (SC) injection
Biological: PF-06741086
PF-06741086 SC injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Study Day 1 to Day 113 Visit
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator.
Study Day 1 to Day 113 Visit
Number of Participants Discontinued From Study Due to TEAEs
Time Frame: Study Day 1 to Day 113 Visit
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
Study Day 1 to Day 113 Visit
Number of Participants With Abnormal Laboratory Findings-Hematology
Time Frame: Baseline to Study Day 113 Visit
Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Predefined criteria for hemoglobin and hematocrit: <0.8*lower limit of normal (LLN) or <0.8*Baseline(Baseline <1.0*LLN); for platelets: <100,000*10^3/mm^3 or <= 0.77*Baseline (Baseline <1.0*LLN).
Baseline to Study Day 113 Visit
Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry
Time Frame: Baseline to Study Day 113
Clinical chemistry evaluation included bilirubin, direct and indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, troponin I, cholesterol and fibrinogen.
Baseline to Study Day 113
Number of Participants With Abnormal Laboratory Findings-Urinalysis
Time Frame: Baseline to Study Day 113 Visit
Urinalysis included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes and bacteria.
Baseline to Study Day 113 Visit
Change From Baseline for Globulin by Dose Cohort
Time Frame: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Blood samples were obtained to determine globulin level in serum, total globulin was derived as total protein other than albumin.
Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort
Time Frame: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Blood samples were obtained to evaluate this ratio. The prothrombin time (PT) is a test that helps evaluate your ability to appropriately form blood clots. The international normalized ratio (INR) is a calculation based on results of a PT that is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin (Coumadin®).
Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort
Time Frame: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
The activated partial thromboplastin time (aPTT) is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood sample were obtained to evaluate aPTT.
Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Change From Baseline for Fibrinogen by Dose Cohort
Time Frame: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen.
Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.
Change From Baseline for Antithrombin III by Dose Cohort
Time Frame: Baseline, Study Day 8, 15, 22 and 29.
Antithrombin (AT) is a protein produced by the liver that helps regulate blood clot formation (i.e., a naturally-occurring mild blood thinner). Blood samples were collected to measure the activity (function) and the amount (quantity) of antithrombin in an individual's blood is used to evaluate the person for excessive blood clotting.
Baseline, Study Day 8, 15, 22 and 29.
Change From Baseline for Troponin I by Dose Cohort
Time Frame: Baseline, Study Day 8, 15, 22, 29, 57 and 85.
Blood samples were collected to measure the level of cardiac-specific troponin I in the blood to help detect heart injury.
Baseline, Study Day 8, 15, 22, 29, 57 and 85.
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Time Frame: Baseline to Study Day 113 Visit
Criteria for potentially clinically important findings in vital signs data were defined as: 1) supine systolic blood pressure (BP): value <90 mm Hg or change >=30 mm Hg increase; 2) Supine diastolic BP: value <50 mm Hg or change >=20 mm Hg increase; 3) Supine pulse rate: value <40 beats/min or >120 beats/min.
Baseline to Study Day 113 Visit
Number of Participants With Electrocardiogram (ECG) Change Meeting Pre-specified Criteria
Time Frame: Baseline to Study Day 29 Visit.
Criteria for potentially clinically important changes in ECG were defined as: PR interval baseline >200 msec and increase of >=25%; PR interval baseline <=200 msec and increase of >=50%; QRS interval increase of >=50%. Only the number of participants meeting pre-defined criteria was reported below.
Baseline to Study Day 29 Visit.
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Time Frame: Baseline to Study Day 113 Visit
Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.
Baseline to Study Day 113 Visit
Number of Participants With Infusion and Injection Site Reactions
Time Frame: Baseline to Study Day 113 Visit
Infusion and injection site reactions included: injection site bruising, injection site erythema, injection site haemorrhage, injection site induration, injection site pain, injection site pruritus, injection site swelling and injection site warmth. Grade of severity was defined as follows: Mild: Transient or mild discomfort (< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible.
Baseline to Study Day 113 Visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Annualized Bleeding Rate (ABR)
Time Frame: Pre-treatment: within 6 months prior to study enrollment; On-study: Day 1 to 9 days after the last dose (Day 78)
Pre-treatment ABR = number of bleeding episodes within 6 months prior to study enrollment (total number of bleeding episodes in hemophilia history CRF) × 2; On-study ABR = number of bleeding episodes occurred within 9 days after the last dose / ([last dose date + 9 - first dose date + 1] / 365.25) The historical On Demand group was constructed using the following internal Pfizer studies: ReFacto AF 3082B2-4432 (B1831004), BeneFIX B1821010, and BeneFIX 3090A1-400 (B1821004). Participants who were on On Demand treatment in B1831004, as well as data from the On Demand period in B1821004 and B1821010 were used to construct the historical On Demand group. The resulting dataset were further filtered to match the key inclusion/exclusion criteria of Study B7841002 based on age and factor activity (18 <=age <=65 and factor activity <=1%).
Pre-treatment: within 6 months prior to study enrollment; On-study: Day 1 to 9 days after the last dose (Day 78)
Plasma PF-06741086 Concentrations
Time Frame: pre-dose on Study Day 1, 24hours (h), 72h post Study Day 1 dosing, pre-dose on Study Day 8, 15 and 22, pre-dose on Study Day 29, 24h, 96h post Study Day 29 dosing, pre-dose on Study Day 57, 168h, 840h post Study Day 57 dosing
Plasma PF-06741086 concentrations were analyzed using a validated, sensitive and specific electrochemiluminescence (ECL) method.
pre-dose on Study Day 1, 24hours (h), 72h post Study Day 1 dosing, pre-dose on Study Day 8, 15 and 22, pre-dose on Study Day 29, 24h, 96h post Study Day 29 dosing, pre-dose on Study Day 57, 168h, 840h post Study Day 57 dosing
Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-06741086
Time Frame: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing
AUClast was calculated by linear/Log trapezoidal method.
Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing
Maximum Plasma Concentration (Cmax) of PF-06741086
Time Frame: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Cmax was observed directly from data.
Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06741086
Time Frame: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Cmin was observed directly from data.
Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Time to Reach Maximum Plasma Concentration (Tmax) of PF-06741086
Time Frame: Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Tmax was observed directly from data as time of first occurrence.
Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of PF-06741086
Time Frame: Pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
The dosing interval tau was 1 week. AUCtau was obtained by linear/log trapezoidal method.
Pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Apparent Clearance After Oral Dose (CL/F) of PF-06741086
Time Frame: Pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
CL/F was calculated by dose/AUCtau.
Pre-dose on Day 29, 24 and 96 hours post Day 29 dosing
Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Total amount of tissue factor pathway inhibitor (TFPI) (bound and unbound) in plasma. TFPI is a protease inhibitor which acts as an antagonist of the extrinsic coagulation pathway via inhibition of tissue factor activated coagulation factor VII (FVIIa) and activated factor X (FXa). Human plasma samples were analyzed for total TFPI concentrations using a validated, sensitive and specific high-performance liquid chromatography tandem mass spectrometric method (LC-MS/MS). Mixed model repeated measures (MMRM) was used to analyze the change from baseline on TFPI.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Change From Baseline in Thrombin Generation (TGA) Lag Time
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
An ex vivo pharmacodynamic measure of thrombin generation (initiation of thrombin generation), the lag time is the time needed to form the first traces of thrombin.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Change From Baseline in Thrombin Generation (TGA) Peak
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
An ex vivo pharmacodynamic measure of thrombin generation (initiation of thrombin generation). The peak represents the highest thrombin concentration that can be generated. There may be patients who reach the peak faster or slower than others and this may represent hyper- or hypocoagulability, respectively.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Change From Baseline in Endogenous Thrombin Generation (TGA) Potential
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
An ex vivo pharmacodynamic measure of thrombin generation. The endogenous TGA potential represents the total amount of active thrombin formed during thrombin generation and the peak height the maximal amount of thrombin formed.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Change From Baseline in Prothrombin Fragments 1 + 2
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
An in vivo pharmacodynamic measure of thrombin generation (prothrombin cleavage). Prothrombin fragment 1+2 (F 1+2) is the amino terminus fragment of the prothrombin molecule. It is a polypeptide with a half-life of approximately 90 minutes. F 1+2 is released from prothrombin when prothrombin is converted to thrombin by the prothrombinase complex.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Change From Baseline in D-Dimer
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
An in vivo pharmacodynamic measure of thrombin generation (fibrin degradation). D-dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. It is normally undetectable or detectable at a very low level unless the body is forming and breaking down blood clots. Then, its level in the blood can significantly rise.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Change From Baseline in Dilute Prothrombin Time
Time Frame: Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
An ex vivo pharmacodynamic measure of thrombin generation (via extrinsic pathway). Clotting time is measured using a dilute prothrombin time reagent consisting of a unique formulation of relipidated recombinant tissue factor and calcium.
Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113
Number of Participants Who Tested Positive for Anti-PF-06741086 Antibody (ADA)
Time Frame: Baseline up to Study Day 113
Human plasma ADA samples were analyzed for the detection of anti PF-06741086 antibodies by using semi-quantitative electrochemiluminescence (ECL) method. The criterion for positive result of ADA samples was ADA titer >=1.53. Treatment induced are negative prior to dosing and become positive during/after dosing. Treatment boosted are positive prior to dosing but titer increases during/after dosing.
Baseline up to Study Day 113
Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)
Time Frame: Baseline up to Study Day 113
Human plasma NAb samples were analyzed for the presence or absence of NAb to PF-06741086 using semi-quantitative electrochemiluminescence (ECL) method. Treatment induced are negative prior to dosing and become positive during/after dosing. Treatment boosted are positive prior to dosing but titer increases during/after dosing.
Baseline up to Study Day 113

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7841002
  • 2016-001885-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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