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Biodistribution of 89Zirconium-labelled GSK2398852 Using PET Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03417830
Recruitment Status : Terminated (Change in benefit/risk profile.)
First Posted : January 31, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The principal aim of this study is to investigate the cardiac uptake of 89Zr-GSK2398852 in subjects with transthyretin cardiomyopathy amyloidosis (ATTR-CM), and its biodistribution to other organs. Low doses of GSK2398852 will be co-administered at levels not high enough for therapeutic benefit. This study will be conducted in two parts: Part A and Part B. Subjects in Part A will participate in up to two dosing sessions and subjects in Part B will participate in one dosing session. Subjects will undergo up to 3 PET scans at varying intervals after 89Zr-GSK2398852 administration. The total duration of study will be approximately 3 to 4 months for subjects in Part A and approximately 2 months for subjects in Part B. Part B of the study will be triggered based on data obtained in Part A and other emerging data.

Condition or disease Intervention/treatment Phase
Amyloidosis Drug: GSK2315698 (CPHPC) Drug: GSK2398852 (unlabeled anti-SAP mAb) Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part A of the study will include 3 subjects with ATTR-CM who will participate in two dosing sessions and Part B of the study will include 3 subjects with ATTR-CM who will participate in one dosing session. A single dosing session will constitute treatment with carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC), total mass dose (TMD) administration of anti-serum amyloid P (SAP) monoclonal antibody (mAb) consisting of in vivo mixing of a single infusion of unlabeled anti-SAP mAb and a separate infusion of 89Zr-GSK2398852 via a different peripheral venous line, and up to 3 serial PET scanning procedures after administration of 89Zr-GSK2398852.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging
Actual Study Start Date : April 6, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Subjects with ATTR-CM in Part A
Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part A will participate in two anti-SAP dosing sessions approximately 26 days in duration. The first two subjects in Part A will have up to three 89Zr PET scans, while the remaining subject will undergo up to two 89Zr PET scans.
Drug: GSK2315698 (CPHPC)
GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.
Other Name: miridesap

Drug: GSK2398852 (unlabeled anti-SAP mAb)
Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.
Other Name: dezamizumab

Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.

Experimental: Subjects with ATTR-CM in Part B
Approximately 3 subjects with either wild type or inherited ATTR-CM will be included. Subjects in Part B will participate in one anti-SAP dosing session. Subjects will undergo up to two 89Zr PET scans.
Drug: GSK2315698 (CPHPC)
GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.
Other Name: miridesap

Drug: GSK2398852 (unlabeled anti-SAP mAb)
Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.
Other Name: dezamizumab

Drug: 89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)
89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.




Primary Outcome Measures :
  1. Standardized Uptake Values (SUV) in focal anatomical regions of the heart following 80-200 milligrams (mg) dose of anti-SAP mAb [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.

  2. SUV in focal anatomical regions of the heart following an anti-SAP mAb dose between 200 mg and <=500 mg [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.

  3. SUV of whole heart following 80-200 mg dose of anti-SAP mAb [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.

  4. SUV of whole heart following an anti-SAP mAb dose between 200 mg and <=500 mg [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.


Secondary Outcome Measures :
  1. Focal radioactivity uptake after 80-200 mg dose of anti-SAP mAb [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.

  2. Focal radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Focal radioactivity uptake in different tissues will be evaluated.

  3. Total radioactivity uptake after 80-200 mg dose of anti-SAP mAb [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.

  4. Total radioactivity uptake after an anti-SAP mAb dose between 200 mg and <=500 mg [ Time Frame: Up to Day 6 ]
    PET images will be visually reviewed to assess the radioactivity distribution. SUV is the measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. Total radioactivity uptake in different tissues will be evaluated.

  5. Maximum concentration in plasma (Cmax) of total mAb [ Time Frame: Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose ]
    Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.

  6. Time associated with Cmax (Tmax) of total mAb [ Time Frame: Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose ]
    Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.

  7. Clearance of total mAb [ Time Frame: Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose ]
    Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.

  8. Terminal half-life (T1/2) of total mAb [ Time Frame: Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose ]
    Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.

  9. Area under the concentration-time profile (AUC) of total mAb [ Time Frame: Day 3 (pre-dose, 4 hours, 7 hours post-dose), Day 4, Day 5, Day 6 and Day 7 post-dose ]
    Blood samples will be collected at indicated time points for measurement of plasma concentrations of GSK2398852. Plasma concentrations of GSK2398852, will be the total of both 89Zr-labeled and unlabeled mAb.

  10. Cmax of 89Zr- GSK2398852 pharmacokinetics of radioactivity (radio-PK) [ Time Frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose ]
    Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.

  11. Tmax of 89Zr- GSK2398852 radio-PK [ Time Frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose ]
    Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.

  12. T1/2 of 89Zr- GSK2398852 radio-PK [ Time Frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose ]
    Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.

  13. AUC of 89Zr- GSK2398852 radio-PK [ Time Frame: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Day 4, Day 5 and Day 6 post-dose ]
    Blood samples will be collected at indicated time points for measurement of radioactivity. The radioactivity will reflect the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration will be measured by scintillation counter.

  14. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Day 28 ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.

  15. Number of subjects with skin rashes [ Time Frame: Up to Day 28 ]
    Rash will be graded as Grade 1 to Grade 4 based on symptoms and body surface area affected.

  16. Number of subjects with cardiac adverse events [ Time Frame: Up to Day 28 ]
    Cardiovascular adverse events will include myocardial infarction/unstable angina, congestive heart failure, arrhythmias, valvulopathy, pulmonary hypertension, cerebrovascular events/stroke and transient ischemic attack, peripheral arterial thromboembolism, deep venous thrombosis/pulmonary embolism and revascularization.

  17. Number of subjects with infusion related reactions [ Time Frame: Up to Day 28 ]
    Number of subjects with infusion related reactions will be summarized.

  18. Number of subjects with abnormal hematology parameters [ Time Frame: Up to Day 28 ]
    The following hematology parameters will be assessed: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), percentage of reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  19. Number of subjects with abnormal clinical chemistry parameters [ Time Frame: Up to Day 28 ]
    The following clinical chemistry parameters will be evaluated: blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin.

  20. Number of subjects with abnormal urine parameters [ Time Frame: Up to Day 28 ]
    The following parameters will be evaluated: specific gravity, potential hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Urine microscopy will be performed if indicated.

  21. Number of subjects with cardiac safety parameters of clinical significance [ Time Frame: Up to Day 28 ]
    The following cardiac chemistry parameters will be evaluated: troponin T and N-terminal prohormone of brain natriuretic peptide (NT-ProBNP).

  22. Number of subjects with abnormal electrocardiogram (ECG) [ Time Frame: Up to Day 28 ]
    12-lead ECGs will be obtained in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the subject.

  23. Number of subjects with abnormal inpatient cardiac telemetry [ Time Frame: Up to Day 11 ]
    Inpatient cardiac monitoring will be performed using inpatient lead II cardiac telemetry.

  24. Number of subjects with abnormal outpatient cardiac telemetry [ Time Frame: Up to Day 18 ]
    Outpatient cardiac monitoring will be performed using a non-implantable remote cardiac telemetry device.

  25. Number of subjects with abnormal temperature [ Time Frame: Up to Day 28 ]
    Temperature will be measured in a semi-supine position after 5 minutes of rest.

  26. Number of subjects with abnormal blood pressure [ Time Frame: Up to Day 28 ]
    Systolic and diastolic blood pressure will be measured in a semi-supine position after 5 minutes of rest.

  27. Number of subjects with abnormal pulse rate [ Time Frame: Up to Day 28 ]
    Pulse rate will be measured in a semi-supine position after 5 minutes of rest.

  28. Number of subjects with abnormal respiratory rate [ Time Frame: Up to Day 28 ]
    Respiratory rate will be measured in a semi-supine position after 5 minutes of rest.

  29. Number of subjects with abnormal physical examination findings [ Time Frame: Up to Day 11 ]
    A brief physical examination will be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be 65 to 80 years of age inclusive, at the time of signing the informed consent.
  • Subjects with a diagnosis of ATTR-CM: a) Wild-type ATTR status must be confirmed by genotyping and have one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of Transthyretin amyloidosis (TTR) as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR ii) Scintigraphy Technetium-99m-labeled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) with confirmed myocardial uptake. b) Hereditary ATTR amyloidosis (example, TTR Val30Met) should have a known amyloidogenic TTR mutation demonstrated by genotyping and is recognized to be primarily associated with cardiomyopathy and one of the following: i) Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarized light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. ii) Scintigraphy: 99mTc-DPD with confirmed myocardial uptake.
  • Both male and female subjects are eligible to participate. a) Male subjects: A male subject must agree to use contraception during the treatment period and for at least 3 months after the last scan and refrain from donating sperm during this period. b) Female subjects: A female subject is eligible to participate if she is not of childbearing potential.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
  • New York Heart Association (NYHA) up to class 3; subjects should be clinically stable for at least 3 months preceding to Screening.

Exclusion Criteria:

  • Cardiomyopathy primarily caused by non-amyloid diseases (example, ischemic heart disease; valvular heart disease).
  • Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) >500 milliseconds (msec).
  • Sustained (at a rate of >=120 beats per minute for >=30 seconds), or symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at Screening/Baseline cardiac monitoring.
  • Systolic blood pressure <=100 millimeters of mercury (mm/Hg) based on triplicate readings at Screening.
  • Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.
  • Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at Screening.
  • Estimated Glomerular filtration rate (eGFR) at Screening <50 milliliters per minute (mL/min) calculated using modification of diet in renal disease (MDRD).
  • Any active and persistent dermatological condition, which in the opinion of the Investigator and Medical Monitor would preclude safe participation.
  • History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation.
  • Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.
  • Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.
  • Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment.
  • Uncontrolled hypertension during Screening.
  • ALT >3 times upper limit of normal (ULN) OR bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Peripheral edema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC.
  • Presence of any co-morbid (example, steroid refractory rheumatoid arthritis), or an uncontrolled medical condition (example, diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a subject.
  • Positive test for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) during Screening, or within 3 months prior to first dose of study treatment.
  • Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis and exfoliative dermatitis).
  • Inability to comprehend and/or understand the study patient information sheet, and/or unwillingness or inability to follow the procedures outlined in the protocol.
  • Has any of the following: a) Fulfillment of diagnostic criteria for Amyloid Light-chain (AL) amyloidosis. b) Fulfillment of diagnostic criteria for amyloid A (AA) or non-TTR hereditary amyloidosis.
  • ATTR Disease Load: c) Histologically proven or clinically suspected gastrointestinal TTR amyloidosis; d) Diffuse skeletal muscle uptake of 99m(Tc)-DPD on Single-photon emission computed tomography (SPECT) imaging (where available); e) Peripheral neuropathy causing more than mild morbidity (example, walking disability; neuropathic pain affecting activities of daily living); f) Proven or clinically suspected intracranial TTR involvement including ophthalmological disease.
  • Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones).
  • Participation in a separate clinical trial involving CPHPC within 3 months of Screening.
  • Any prohibited concomitant medication within referenced timeframe.
  • Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.
  • Orthopnea of sufficient severity to preclude supine scanning as determined at Screening.
  • Inability to fit inside scanner due to body size (girth).
  • History of claustrophobia.
  • Contraindication to magnetic resonance imaging (MRI) contrast agents.
  • Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other metallic objects; b) Intra-orbital metal fragments that have not been removed; c) Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-magnetic resonance (MR) conditional heart valves; d) Inner ear implants.
  • Donation of blood or blood products in excess of 500 milliliters (mL) within 84 days of Screening.
  • Poor or unsuitable venous access.

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): NCT03417830


Locations
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Sweden
GSK Investigational Site
Uppsala, Sweden, SE-751 85
GSK Investigational Site
Uppsala, Sweden, SE-751
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] October 4, 2017
Statistical Analysis Plan  [PDF] February 19, 2019


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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03417830     History of Changes
Other Study ID Numbers: 204512
2017-002665-22 ( EudraCT Number )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
miridesap
GSK2315698
89Zirconium labelled
Positron Emission Tomography
Transthyretin cardiomyopathy
GSK2398852
dezamizumab

Additional relevant MeSH terms:
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Cardiomyopathies
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases