| 1 |
NCT01171859 |
Completed |
Safety, Efficacy and Pharmacokinetics of Doxycycline Plus Tauroursodeoxycholic Acid in Transthyretin Amyloidosis |
- Transthyretin Amyloidosis
|
- Drug: Doxycycline + Tauroursodeoxycholic acid
|
Interventional |
Phase 2 |
- IRCCS Policlinico S. Matteo
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response rate to doxycycline + tauroursodeoxycholic acid treatment
- Number of patients experiencing treatment-emergent adverse events
- Change in quality of life
- (and 4 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT01171859 |
DOXYTUDCA2010
2010-020422-17 |
|
July 2010 |
April 2015 |
October 2015 |
July 29, 2010 |
February 25, 2016 |
|
- Amyloid Research and Treatment Centre, Biotechnology Research Laboratories
Pavia, Italy
|
| 2 |
NCT03328338 |
Not yet recruiting |
Mitochondrial Function in Transthyretin Amyloidosis |
|
|
Observational |
|
- University Hospital Center of Martinique
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Oxygen consumption measure in subcutaneous abdominal fat biopsies
- Rates of oxygen consumption
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03328338 |
16/E/17 |
MIT-Amylose |
January 2018 |
January 2019 |
January 2019 |
November 1, 2017 |
November 1, 2017 |
|
- CHU de Martinique
Fort-de-France, Martinique
|
| 3 |
NCT03397810 |
Not yet recruiting |
Effect of Low Dose Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study |
|
- Radiation: low dose radiotherapy
|
Interventional |
Not Applicable |
- Doctor René Nkoulou
- University Hospital, Geneva
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assessment of the degree of amyloid
- Safety and adverse event associated with cardiac low dose RT
- Modification in echocardiographic global longitudinal strain
- (and 3 more...)
|
36 |
All |
65 Years and older (Adult, Senior) |
NCT03397810 |
2017-00640 |
|
February 1, 2018 |
January 4, 2020 |
December 30, 2020 |
January 12, 2018 |
January 12, 2018 |
|
|
| 4 |
NCT02798705 |
Recruiting |
Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Overt microvascular disease
- Correlation between CFR or IMR and E/E', 2D strain measure by echocardiography
- Comparison of proportion of overt microvascular disease (CFR≤2 and IMR≥25) in amyloidosis patient with or without relative perfusion defect in myocardial perfusion imaging (ex> adenosine-SPECT or perfusion MRI)involvement
- (and 5 more...)
|
30 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02798705 |
AMYL2016-04-122 |
|
May 2016 |
April 2020 |
December 2020 |
June 14, 2016 |
June 16, 2016 |
|
- Samsung Medical Center
Seoul, Korea, Republic of
|
| 5 |
NCT03190577 |
Recruiting |
Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology |
- Familial Amyloid Neuropathy
- Transthyretin Amyloidosis
|
|
Interventional |
Not Applicable |
- Nantes University Hospital
- Pfizer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- to evaluate the prevalence of TTR amyloidosis
- To identify risk factors of carrying TTR mutations amongst those presenting with "unknown aetiology" neuropathy
- Description of the TTR-FAP cohort
|
400 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03190577 |
RC16_0427 |
PRE-TRANS |
September 21, 2017 |
January 30, 2021 |
January 30, 2021 |
June 19, 2017 |
November 21, 2017 |
|
- Chu Angers
Angers, France - Chru Brest
Brest, France - Chd La Roche Sur Yon
La Roche-sur-Yon, France - (and 9 more...)
|
| 6 |
NCT03040427 |
Recruiting |
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis |
|
|
Interventional |
Phase 4 |
- Wael Jaber
- Avid Radiopharmaceuticals
- The Cleveland Clinic
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Frequency of positive studies as determined by the tracer uptake by the heart.
- Development of clinical symptoms of cardiac amyloidosis by conventional cardiac testing.
- Correlation of F-18 florbetapir PET scan with TcPYP scan.
|
40 |
All |
18 Years to 95 Years (Adult, Senior) |
NCT03040427 |
16-960 |
|
January 2017 |
December 2018 |
January 2019 |
February 2, 2017 |
January 5, 2018 |
|
- Cleveland Clinic Foundation (Main Campus)
Cleveland, Ohio, United States
|
| 7 |
NCT01683825 |
Recruiting |
Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography |
|
- Drug: F-18 florbetapir PET
|
Interventional |
Phase 4 |
- Brigham and Women's Hospital
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Mean Myocardial Radiotracer Uptake
- Reproducibility of Myocardial Radiotracer Uptake
|
45 |
All |
18 Years and older (Adult, Senior) |
NCT01683825 |
2012P001322 |
|
September 2012 |
June 2018 |
June 2018 |
September 12, 2012 |
January 24, 2018 |
|
- Brigham and Women's Hospital
Boston, Massachusetts, United States
|
| 8 |
NCT03481972 |
Not yet recruiting
New |
A Study of Doxycycline and Tauroursodeoxycholic Acid (Doxy/TUDCA) Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin |
- Transtyrethin Cardiac Amyloidosis
|
- Drug: Doxycycline and tauroursodeoxycholic acid
- Drug: Standard of care
|
Interventional |
Phase 3 |
- IRCCS Policlinico S. Matteo
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the efficacy of Doxy/TUDCA in patients with cardiac ATTR amyloidosis, comparing survival free at 18 months of patients receiving Doxy/TUDCA + standard supportive therapy with that of patients in standard supportive therapy alone.
- To compare overall survival at 18 and 30 months of patients receiving Doxy/TUDCA in addition to standard supportive therapy with that of patients receiving standard supportive therapy alone.
|
102 |
All |
18 Years and older (Adult, Senior) |
NCT03481972 |
AC 011 IT |
|
April 2018 |
April 2021 |
April 2021 |
March 29, 2018 |
March 29, 2018 |
|
|
| 9 |
NCT02191826 |
Completed |
Study of SOM0226 in Familial Amyloid Polyneuropathy |
- Familial Amyloid Polyneuropathy (FAP)
|
|
Interventional |
Phase 1
Phase 2 |
- SOM Biotech SL
- Hospital Vall d'Hebron
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- TTR stabilization
- Pharmacodynamics assessment
- Safety
|
17 |
All |
18 Years and older (Adult, Senior) |
NCT02191826 |
SOMCT01-C
2014-001586-27 |
|
July 2014 |
November 2015 |
November 2015 |
July 16, 2014 |
November 30, 2016 |
|
- Hospital Vall d'Hebron
Barcelona, Catalonia, Spain
|
| 10 |
NCT01623245 |
Completed |
Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy |
- Cardiac Amyloidosis
- Amyloidosis in Transthyretin (TTR)
- Hypertrophic Cardiomyopathy (HCM)
|
|
Observational |
|
- Thibaud Damy
- French Cardiology Society
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Number of ATTRm mutations
- Genotype and clinical factors
|
294 |
All |
18 Years and older (Adult, Senior) |
NCT01623245 |
11714 |
Amylo |
June 2012 |
December 2014 |
December 2014 |
June 19, 2012 |
November 24, 2017 |
|
- Henri Mondor Hospital
Creteil, France
|
| 11 |
NCT01435655 |
Completed
Has Results |
The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin |
- Transthyretin Familial Amyloid Polyneuropathy
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Transthyretin (TTR) Stabilization at Week 8 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay
- Change From Baseline in Neuropathy Impairment Score (NIS); NIS (Total), NIS-LL (Lower Limb) and NIS-UL (Upper Limb) at Week 26, Week 52 and Week 78
- Change From Baseline in Scores of the Total Quality of Life (TQOL) and 5 Domains as Measured by the Norfolk QOL - Diabetic Neuropathy (Norfolk QOL-DN) at Week 26, Week 52 and Week 78.
- (and 5 more...)
|
10 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01435655 |
B3461010 |
|
November 2011 |
February 2014 |
February 2014 |
September 16, 2011 |
September 9, 2015 |
September 9, 2015 |
- Kumamoto University Hospital/Department of Neurology
Kumamoto-shi, Kumamoto, Japan - Shinshu University Hospital/Department of Medicine (Neurology and Reumatology)
Matsumoto-shi, Nagano, Japan
|
| 12 |
NCT01855360 |
Completed |
Tolerability and Efficacy of a Combination of Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy |
- Amyloidosis; Heart (Manifestation)
- Senile Cardiac Amyloidosis
|
- Drug: Tauroursodeoxycholic Acid and Doxycycline
|
Interventional |
Phase 1
Phase 2 |
- Brigham and Women's Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The rate of progression of transthyretin cardiac amyloidosis, as measured by changes in strain echocardiography, in a group of patients taking a combination of doxycycline and TUDCA.
- Number of patients with adverse events to the medications over the period of therapy (18 months)
- To evaluate general and health related quality of life (QoL) in SSA and ATTR subjects.
|
38 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01855360 |
BWHAMY1 |
|
June 2013 |
May 31, 2015 |
May 31, 2015 |
May 16, 2013 |
June 20, 2017 |
|
- Brigham and Women's Hospital
Boston, Massachusetts, United States
|
| 13 |
NCT00791492 |
Completed
Has Results |
An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy |
- Familial Amyloid Polyneuropathy
- ATTR-PN
|
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6
- Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12
- Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6
- (and 10 more...)
|
86 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00791492 |
FX-006
B3461021 |
|
July 2008 |
August 2008 |
October 2010 |
November 14, 2008 |
December 17, 2012 |
December 17, 2012 |
- FLENI Departamento de Hepatología y Transplante de Organos
Buenos Aires, Argentina - FLENI-Hepatology and Organ Transplant Dept.
Ciudad de Buenos Aires, Argentina - Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, Brazil - (and 8 more...)
|
| 14 |
NCT03431896 |
Recruiting |
Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis |
- Amyloidosis
- Amyloid
- Amyloid Neuropathies, Familial
- (and 4 more...)
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Average % change in oligomers in patients with new onset TTR amyloid symptoms
- % change of oligomer levels relative to baseline level in patients with ATTR specific medication changes
|
10 |
All |
Child, Adult, Senior |
NCT03431896 |
17-1301 |
MED-hATTR |
February 1, 2018 |
February 15, 2024 |
February 15, 2024 |
February 13, 2018 |
February 13, 2018 |
|
- Cleveland Clinic
Cleveland, Ohio, United States
|
| 15 |
NCT02966522 |
Recruiting |
Thalidomide/Dexamethasone Treatment And PET Evaluation In Organ Involvemenet of Cardiac Amyloidosis |
|
- Drug: Thalidomide
- Drug: Dexamethasone
|
Interventional |
Phase 2 |
- Seoul National University Hospital
- CW pharmaceutical company
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Hematologic response
- Cardiac response
- Maximal LV myocardium-blood cavity ratio
- (and 6 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02966522 |
H-1512-129-730 |
TaPiOCA |
October 2016 |
September 2019 |
September 2019 |
November 17, 2016 |
October 26, 2017 |
|
- Seoul National University Hospital
Seoul, Korea, Republic of
|
| 16 |
NCT00409175 |
Completed
Has Results |
Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis |
- Familial Amyloid Polyneuropathy
|
- Drug: Fx-1006A
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 18
- Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 18
- Change From Baseline in Neuropathy Impairment Score- Lower Limb (NIS-LL) Score at Month 6, 12 and 18
- (and 7 more...)
|
128 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00409175 |
FX-005
B3461020 |
|
January 2007 |
May 2009 |
May 2009 |
December 8, 2006 |
December 17, 2012 |
December 17, 2012 |
- MGH Neuropathy Laboratory
Boston, Massachusetts, United States - FLENI-Hepatology and Organ Transplant Dept.
Ciudad de Buenos Aires, Buenos Aires Province, Argentina - Hospital Universitário Prof. Clementino Fraga Filho-UFRJ
Rio de Janeiro, Southeast, Brazil - (and 7 more...)
|
| 17 |
NCT02792790 |
Active, not recruiting |
Carpal Tunnel Syndrome and Amyloid Cardiomyopathy |
- Amyloidosis
- Cardiomyopathy
- Transthyretin Amyloidosis
- (and 2 more...)
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of transthyretin (TTR) amyloidosis in patients undergoing carpal tunnel release surgery
- Cardiac progression of transthyretin (TTR) amyloidosis in carpal tunnel biopsy-positive patients
- Prevalence of abnormal transthyretin (TTR) kinetics in patients undergoing carpal tunnel surgery
- Early transthyretin (TTR) amyloid cardiomyopathy identification in carpal tunnel biopsy-positive patients
|
96 |
All |
50 Years and older (Adult, Senior) |
NCT02792790 |
16-158 |
|
March 2016 |
May 2021 |
May 2021 |
June 8, 2016 |
January 11, 2018 |
|
- Lutheran Hospital
Cleveland, Ohio, United States
|
| 18 |
NCT02016365 |
Completed |
Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis |
- Transthyretin Amyloidosis
- Cardiomyopathy
|
- Drug: Doxycycline
- Drug: Ursodeoxycholic acid
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The efficacy on serum N terminal proBNP (NT-proBNP)
- Modified Body Mass Index (mBMI) reduction
- Increase of septum thickness
- (and 3 more...)
|
55 |
All |
50 Years and older (Adult, Senior) |
NCT02016365 |
EudraCT No:2011-005236-25 |
Dox/Urso |
February 2012 |
December 2014 |
December 2014 |
December 20, 2013 |
May 12, 2016 |
|
- Dept of Clinical Medicin, Ptieå Hospital
Piteå, Sweden - Dept of clinical medicin, Skellefteå Hospital
Skellefteå, Sweden - Dept of Clinical Medicine, Umeå University Hospital
Umeå, Sweden
|
| 19 |
NCT00628745 |
Recruiting |
Transthyretin-Associated Amyloidoses Outcome Survey (THAOS) |
- Transthyretin Mutations
- Transthyretin Amyloidosis
|
- Other: None. Observational Study.
|
Observational |
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- The objectives of THAOS are to describe the population of patients affected with TTR amyloidoses and to enhance the understanding of the disease natural history, including the variability and progression of the hereditary and acquired forms of disease.
|
1 |
All |
18 Years and older (Adult, Senior) |
NCT00628745 |
B3461001
FX-R-001
THAOS |
THAOS |
July 27, 2007 |
June 16, 2021 |
June 16, 2021 |
March 5, 2008 |
January 23, 2018 |
|
- Mayo Clinic Arizona
Phoenix, Arizona, United States - University of California, Irvine
Orange, California, United States - University of California - San Francisco, UCSF Department of Neurology
San Francisco, California, United States - (and 91 more...)
|
| 20 |
NCT03333551 |
Not yet recruiting |
Cardiac Uptake of 18F Florbetapir in Patients Undergoing Chemotherapy |
|
- Drug: F18 Florbetapir (amyvid) cardiac PET/CT imaging
|
Interventional |
Phase 4 |
- Medical College of Wisconsin
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Relative change in cardiac uptake of 18F florbetapir prior to chemotherapy and after six months of chemotherapy.
- six minute walk test
- Hematologic response
- (and 2 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT03333551 |
29197 |
|
April 2018 |
April 2019 |
April 2019 |
November 7, 2017 |
February 19, 2018 |
|
|
| 21 |
NCT01432587 |
Completed |
The Effect of Diflunisal on Familial Transthyretin Amyloidosis |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Changes in the Kumamoto scale
- Changes in modified body mass index (mBMI)
- Changes in paraneoplastic neurological disorders (PND) scale
- (and 2 more...)
|
55 |
All |
18 Years and older (Adult, Senior) |
NCT01432587 |
DFNS01
2011-000776-34 |
DFNS01 |
August 2011 |
December 2014 |
December 2014 |
September 13, 2011 |
August 24, 2015 |
|
- Dept of Clinical Medicin, Ptieå Hospital
Piteå, Sweden - Dept of clinical medicin, Skellefteå Hospital
Skellefteå, Sweden - Dept of Clinical Medicine, Umeå University Hospital
Umeå, Sweden
|
| 22 |
NCT01737398 |
Completed |
Efficacy and Safety of IONIS-TTR Rx in Familial Amyloid Polyneuropathy |
- FAP
- Familial Amyloid Polyneuropathy
- TTR
- (and 2 more...)
|
- Drug: IONIS-TTR Rx
- Drug: Placebo
|
Interventional |
Phase 3 |
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy of IONIS-TTR Rx as measured by change from baseline in the modified Neuropathy Impairment Score +7
- Efficacy of IONIS-TTR Rx as measured by change from baseline in the Norfolk Quality of Life Diabetic Neuropathy questionnaire
- Efficacy of IONIS-TTR Rx based on the change from baseline in the following measures:
- Pharmacodynamic effect of IONIS-TTR Rx based on the change from baseline in transthyretin and retinol binding protein 4
|
172 |
All |
18 Years to 82 Years (Adult, Senior) |
NCT01737398 |
ISIS 420915-CS2 |
|
December 2012 |
March 2017 |
October 2017 |
November 29, 2012 |
November 8, 2017 |
|
- University of California, Irvine
Orange, California, United States - Indiana University School of Medicine
Indianapolis, Indiana, United States - Johns Hopkins University Bayview Medical Center
Baltimore, Maryland, United States - (and 21 more...)
|
| 23 |
NCT02175004 |
Active, not recruiting |
Open-Label Extension Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP) |
- FAP
- Familial Amyloid Polyneuropathy
- TTR
- (and 2 more...)
|
|
Interventional |
Phase 3 |
- Ionis Pharmaceuticals, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Types of adverse events that occur during treatment
- Change from baseline in blood pressure (systolic and diastolic), heart rate, and body weight
- Change from baseline in results of routine laboratory test panel (routine serum chemistry, hematology, and urinalysis)
- (and 10 more...)
|
135 |
All |
Child, Adult, Senior |
NCT02175004 |
ISIS 420915-CS3 |
|
June 2014 |
June 2022 |
September 2022 |
June 26, 2014 |
October 20, 2017 |
|
- University of California, Irvine
Orange, California, United States - Indiana University School of Medicine
Indianapolis, Indiana, United States - Johns Hopkins University Bayview Medical Center
Baltimore, Maryland, United States - (and 19 more...)
|
| 24 |
NCT02260466 |
Recruiting |
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. |
- Heart Disease
- Aging
- Amyloidosis
- Aortic Valve Stenosis
|
- Other: a basal LV septum biopsy
|
Interventional |
Not Applicable |
- French Cardiology Society
- Pfizer
- Henri Mondor University Hospital
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Clinical composite criterion: All causes of death and cardiovascular hospitalization at 1 year after surgery
|
180 |
All |
18 Years and older (Adult, Senior) |
NCT02260466 |
2013-02 |
AMYLOCARTESIAN |
October 2014 |
June 2018 |
July 2019 |
October 9, 2014 |
August 22, 2017 |
|
- Hôpital Henri Mondor
Creteil, France - Chu Fort de France
Fort de France, France - CHU Limoges
Limoges, France - (and 2 more...)
|
| 25 |
NCT00630864 |
Completed
Has Results |
The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients With Non-V30M Transthyretin Amyloidosis |
- Transthyretin-associated Amyloidosis With Polyneuropathy
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6
- Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Month 6 and 12
|
21 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00630864 |
FX1A-201
B3461022 |
|
June 2008 |
January 2010 |
January 2010 |
March 7, 2008 |
January 18, 2013 |
December 17, 2012 |
- Johns Hopkins Hospital
Baltimore, Maryland, United States - CHU de Bicetre
Paris, France - Universitatsklinikum Munster, Transplant Hepatology
Munster, Germany - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
IRCCS - Policlinico San Matteo, Pavia, Italy
|
| 26 |
NCT03352089 |
Recruiting |
Positron Emission Tomography / Magnetic Resonance Imaging in Aortic Stenosis |
- Aortic Stenosis
- Transthyretin Amyloidosis
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- PET signal intensity quantified by calculation of standard uptake values
|
30 |
All |
70 Years and older (Senior) |
NCT03352089 |
17/SS/0066 |
PASS |
November 1, 2017 |
November 1, 2018 |
November 1, 2018 |
November 24, 2017 |
November 24, 2017 |
|
- University of Edinburgh / NHS Lothian
Edinburgh, Midlothian, United Kingdom
|
| 27 |
NCT03232632 |
Recruiting |
Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries. |
|
- Drug: PET with 18 F-Flutemetamol
|
Interventional |
Early Phase 1 |
- University Hospital, Toulouse
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT03232632 |
13 199 02 |
AMYLCAR |
March 15, 2017 |
December 2017 |
January 2018 |
July 28, 2017 |
July 28, 2017 |
|
- University Hospital Toulouse
Toulouse, France
|
| 28 |
NCT03119558 |
Recruiting |
PET/MRI Evaluation of Cardiac Amyloid |
|
- Drug: 18F‑Florbetaben (Neuraceq®) PET/MRI
|
Interventional |
Early Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of participants with 18F‑Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03119558 |
IRB-35049 |
|
May 26, 2016 |
August 2019 |
August 2020 |
April 18, 2017 |
April 12, 2018 |
|
- Stanford University
Stanford, California, United States
|
| 29 |
NCT03098901 |
Not yet recruiting |
Radioisotope Scintigraphy to Establish Incidence of Cardiac Amyloidosis Among Patients With Otherwise Unexplained Cardiac Disease |
|
- Diagnostic Test: Tc99m-labeled pyrophosphate scan
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- diagnosis or exclusion of any type of cardiac amyloidosis;
|
100 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03098901 |
KMC-0018-17 |
|
April 15, 2017 |
April 15, 2018 |
April 15, 2018 |
April 4, 2017 |
April 5, 2017 |
|
|
| 30 |
NCT03414632 |
Recruiting |
Transthyretin Cardiac Amyloidosis in HFpEF |
- Heart Failure With Preserved Ejection Fraction
|
|
Interventional |
Early Phase 1 |
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
|
300 |
All |
60 Years and older (Adult, Senior) |
NCT03414632 |
17-003021 |
|
December 1, 2017 |
September 2019 |
September 2019 |
January 30, 2018 |
January 30, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 31 |
NCT03322319 |
Completed |
Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose) |
- Left Ventricular Hypertrophy
|
- Procedure: Tissue biopsies
|
Interventional |
Not Applicable |
- University Hospital Center of Martinique
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Diagnosis of cardiac amyloidosis.
- Subtyping of cardiac amyloidosis
|
175 |
All |
18 Years and older (Adult, Senior) |
NCT03322319 |
12/B/17 |
|
September 23, 2013 |
December 2, 2015 |
January 18, 2016 |
October 26, 2017 |
October 27, 2017 |
|
- Centre Hospitalier de Basse-Terre
Basse-Terre, Guadeloupe - CHU de Martinique
La Trinité, Martinique
|
| 32 |
NCT02641145 |
Recruiting |
Molecular Imaging of Primary Amyloid Cardiomyopathy |
- Amyloidosis, Primary
- Cardiomyopathy
|
- Radiation: F-18 florbetapir/C-11 acetate PET
- Device: MRI
- Radiation: N-13 ammonia PET
|
Interventional |
Not Applicable |
- Brigham and Women's Hospital
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
- American Heart Association
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 months
- Change in Serum oxidative stress markers from baseline to 6 months and 12 months
- Change in Myocardial oxidative metabolism markers from baseline to 6 months
- (and 3 more...)
|
125 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02641145 |
2015P002477
1R01HL130563-01A1 |
MICA |
April 2016 |
April 2020 |
April 2020 |
December 29, 2015 |
December 4, 2017 |
|
- Brigham and Womens' Hospital
Boston, Massachusetts, United States
|
| 33 |
NCT03029026 |
Recruiting |
The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis. |
- Cardiac Amyloidosis
- Aortic Stenosis
|
- Other: Baseline assessment
- Procedure: Transthoracic echocardiography
- Procedure: 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid scintigraphy
- (and 4 more...)
|
Observational |
|
- Queen Mary University of London
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Patient mortality
- Major adverse cardiovascular events (MACE)
- Length of hospital stay
- (and 2 more...)
|
250 |
All |
75 Years and older (Senior) |
NCT03029026 |
006974 |
ATTRact-AS |
September 2016 |
April 2019 |
April 2019 |
January 24, 2017 |
April 19, 2018 |
|
- Barts Heart Centre
London, United Kingdom - The John Radcliffe Hospital
Oxford, United Kingdom
|
| 34 |
NCT03294707 |
Recruiting |
Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10 |
- Amyloid Cardiomyopathy, Transthyretin-Related
|
- Drug: AG10 oral tablet
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 1 |
- Eidos Therapeutics
- Celerion
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety & tolerability: individual and summary blood pressures, heart rate, ECG and lab data presented in tabular form with descriptive statistics. Adverse events will be tabulated and summarized by Part A (SAD) vs. B (MAD), and treatment.
- Pharmacokinetic Assessments: T1/2
- Pharmacokinetic Assessments: Tmax
- (and 10 more...)
|
96 |
All |
18 Years to 55 Years (Adult) |
NCT03294707 |
AG10-001 |
|
September 11, 2017 |
February 2018 |
June 2018 |
September 27, 2017 |
September 27, 2017 |
|
- Celerion
Tempe, Arizona, United States
|
| 35 |
NCT03458130 |
Not yet recruiting |
Study of AG10 in Amyloid Cardiomyopathy |
- Familial ATTR-CM (ATTRm-CM, or FAC) and Wild-type ATTR-CM (ATTRwt-CM)
|
- Drug: AG10
- Drug: Placebo Oral Tablet
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Assessment of safety and tolerability
- AG10 Pharmacokinetics AUC
- AG10 Pharmacodynamic Assessments of TTR stabilization by Flourescent Polarization Exclusion Assay
- (and 2 more...)
|
45 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT03458130 |
AG10-201 |
|
April 30, 2018 |
September 28, 2018 |
September 28, 2018 |
March 8, 2018 |
April 11, 2018 |
|
- Cedars-Sinai Medical Center
Beverly Hills, California, United States - Stanford University
Palo Alto, California, United States - University of California San Francisco
San Francisco, California, United States - (and 10 more...)
|
| 36 |
NCT00694161 |
Completed
Has Results |
The Effects Of Fx-1006A On Transthyretin Stabilization And Clinical Outcome Measures In Patients With V122I Or Wild-Type TTR Amyloid Cardiomyopathy |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Week 6
- Percentage of Participants With Stabilized Transthyretin (TTR Tetramer) at Month 6 and 12
|
35 |
All |
40 Years and older (Adult, Senior) |
NCT00694161 |
FX1B-201
B3461025 |
|
August 2008 |
January 2010 |
January 2010 |
June 10, 2008 |
January 11, 2013 |
December 18, 2012 |
- Emory University School of Medicine
Atlanta, Georgia, United States - University of Chicago
Chicago, Illinois, United States - Johns Hopkins Hospital
Baltimore, Maryland, United States - (and 3 more...)
|
| 37 |
NCT02791230 |
Recruiting |
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy |
- Transthyretin (TTR) Amyloid Cardiomyopathy
|
- Drug: Tafamidis meglumine
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- All-cause mortality and incidence of treatment emergent adverse events
|
330 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02791230 |
B3461045
2016-000868-42 |
|
June 13, 2016 |
December 23, 2021 |
December 31, 2021 |
June 6, 2016 |
April 17, 2018 |
|
- The Kirkland Clinic of UAB Hospital
Birmingham, Alabama, United States - UAB Hospital
Birmingham, Alabama, United States - Cardiovascular Clinical Trials Unit (CCTU)
Birmingham, Alabama, United States - (and 68 more...)
|
| 38 |
NCT01981837 |
Completed |
Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis |
|
- Drug: ALN-TTRSC (revusiran) for subcutaneous administration
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation.
- Pharmacokinetics (PK) of ALN-TTRSC (revusiran) (Cmax, tmax, t1/2, AUC, CL, Vss, Vz)
- Effect of ALN-TTRSC (revusiran) on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels)
|
26 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01981837 |
ALN-TTRSC-002 |
|
December 2013 |
October 2014 |
January 2015 |
November 13, 2013 |
January 29, 2018 |
|
- Clinical Trial Site
Boston, Massachusetts, United States - Clinical Trial Site
New York, New York, United States - Clinical Trial Site
Cleveland, Ohio, United States - Clinical Trial Site
London, United Kingdom
|
| 39 |
NCT02292186 |
Completed |
A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis |
|
- Drug: Revusiran (ALN-TTRSC)
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability of long-term dosing with revusiran (ALN-TTRSC) as measured by number of adverse events in patients with transthyretin (TTR) cardiac amyloidosis
- Assessment of changes from baseline in serum TTR
- Mortality
- (and 2 more...)
|
25 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02292186 |
ALN-TTRSC-003 |
|
October 2014 |
February 22, 2017 |
February 22, 2017 |
November 17, 2014 |
December 12, 2017 |
|
- Clinical Trial Site
Boston, Massachusetts, United States - Clinical Trial Site
New York, New York, United States - Clinical Trial Site
Cleveland, Ohio, United States - (and 2 more...)
|
| 40 |
NCT01994889 |
Completed |
Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy |
- Transthyretin (TTR) Amyloid Cardiomyopathy
|
- Drug: Tafamidis
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- All-cause mortality and frequency of cardiovascular-related hospitalization
- 6-Minute Walk Test (6MWT).
- Kansas City Cardiomyopathy Questionnaire (KCCQ)
- (and 4 more...)
|
441 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT01994889 |
B3461028
2012-002465-35
ATTR-ACT |
ATTR-ACT |
December 2013 |
February 2018 |
February 2018 |
November 26, 2013 |
April 23, 2018 |
|
- University Hospital, University of Alabama at Birmingham
Birmingham, Alabama, United States - Mayo Clinic Hospital
Phoenix, Arizona, United States - Altman Clinical Translational Research institute
La Jolla, California, United States - (and 53 more...)
|
| 41 |
NCT00935012 |
Active, not recruiting |
Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy |
|
|
Interventional |
Phase 3 |
|
Industry |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To obtain additional, long-term, open-label safety and efficacy data for tafamidis in patients with transthyretin amyloid cardiomyopathy (TTR-CM).
- To continue to provide the investigational product tafamidis to patients with TTR-CM who completed Protocol Fx1B-201
|
32 |
All |
40 Years and older (Adult, Senior) |
NCT00935012 |
FX1B-303
B3461026 |
|
September 2009 |
December 2021 |
December 2021 |
July 8, 2009 |
December 4, 2017 |
|
- University of Chicago Medical Center
Chicago, Illinois, United States - Johns Hopkins Hospital
Baltimore, Maryland, United States - Brigham and Women's Hospital
Boston, Massachusetts, United States - Clinical Cardiovascular Research Lab for the Elderly (CCRLE) Columbia Universtiy
New York, New York, United States
|
| 42 |
NCT02252653 |
Completed |
DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis |
- Familial Amyloidotic Cardiomyopathy (FAC)
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of patients with of Transthyretin (TTR) mutations
- Assessment of the presence of amyloid in tissue
- Quantification of biomarkers of cardiac function in serum
- (and 3 more...)
|
1010 |
All |
18 Years and older (Adult, Senior) |
NCT02252653 |
ALN-TTR-NT-002 |
|
June 2014 |
January 2016 |
March 2016 |
September 30, 2014 |
July 20, 2016 |
|
- Clinical Trial Site
Little Rock, Arkansas, United States - Clinical Trial Site
Bakersfield, California, United States - Clinical Trial Site
La Mesa, California, United States - (and 55 more...)
|
| 43 |
NCT00294671 |
Completed
Has Results |
The Effect of Diflunisal on Familial Amyloidosis |
- Familial Amyloid Polyneuropathy
- Familial Amyloidosis
|
- Drug: diflunisal
- Other: placebo
|
Interventional |
Phase 2
Phase 3 |
- Boston University
- Food and Drug Administration (FDA)
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / U.S. Fed / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Neurologic Impairment Score + 7 (NIS+7)
- Kumamoto Neurologic Scale;
- Modified Body Mass Index (mBMI);
- (and 2 more...)
|
130 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00294671 |
R01NS051306
FD R 002532 |
|
February 2006 |
December 2012 |
December 2012 |
February 22, 2006 |
March 17, 2017 |
March 17, 2017 |
- Amyloidosis Center, Boston Medical Center
Boston, Massachusetts, United States - Mayo Clinic Rochester
Rochester, Minnesota, United States - Mount Sinai School of Medicine, Department of Medicine
New York, New York, United States - (and 5 more...)
|
| 44 |
NCT02939820 |
Available |
Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR) |
- TTR-mediated Amyloidosis
- Amyloidosis, Hereditary
- Amyloid Neuropathies, Familial
- (and 3 more...)
|
- Drug: patisiran (ALN-TTR02)
|
Expanded Access |
|
|
Industry |
|
|
|
All |
18 Years and older (Adult, Senior) |
NCT02939820 |
ALN-TTR02-007 |
|
|
|
|
October 20, 2016 |
February 7, 2018 |
|
- Kaiser Permanente
Oakland, California, United States - MedStar Washington Hospital
Washington, District of Columbia, United States - Mayo Clinic - Jacksonville
Jacksonville, Florida, United States - (and 17 more...)
|
| 45 |
NCT00925002 |
Active, not recruiting |
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To obtain additional, long-term, open-label safety and efficacy data for Fx-1006A in patients with transthyretin (TTR) amyloidosis (ATTR)
- To continue to provide the investigational product Fx-1006A until its market availability to patients with ATTR who have completed Protocol Fx-006 or Protocol Fx1A-201
|
93 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00925002 |
FX1A-303
B3461023
2009-011535-12 |
|
August 5, 2009 |
December 31, 2021 |
December 31, 2021 |
June 19, 2009 |
March 27, 2018 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States - FLENI
Ciudad Autonoma de Buenos aires, Argentina - Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro
Rio de Janeiro, RJ, Brazil - (and 10 more...)
|
| 46 |
NCT02462213 |
Withdrawn |
Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging |
- Amyloidosis
- Paraproteinemias
- Cardiomyopathies
|
- Other: Amyloidosis
- Other: Cardiac Amyloidosis
|
Observational |
|
- University of Cincinnati
- The Christ Hospital
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Identification of cardiac amyloidosis using contrast cardiovascular MRI
- All cause mortality
|
0 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02462213 |
2013-3043 |
PICA-CMR |
October 2013 |
December 2017 |
December 2017 |
June 3, 2015 |
October 26, 2017 |
|
- University of Cincinnati
Cincinnati, Ohio, United States
|
| 47 |
NCT02627820 |
Withdrawn |
The Effect of an Antisense Oligonucleotide to Lower Transthyretin (TTR) Levels on the Progression of -Wild-type TTR Involving the Heart |
|
- Drug: Isis 420915/GSK 299872
|
Interventional |
Phase 2 |
- Brigham and Women's Hospital
- GlaxoSmithKline
- Ionis Pharmaceuticals, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Systolic strain imaging by echocardiographic speckle tracking
- Systolic strain evaluation by echocardiography
- Echocardiographic determination of Mean thickness of LV septum and posterior wall (units = mm)
- (and 5 more...)
|
0 |
All |
50 Years to 90 Years (Adult, Senior) |
NCT02627820 |
2015-P001574 |
|
January 2016 |
December 2018 |
December 2018 |
December 11, 2015 |
August 10, 2016 |
|
|
| 48 |
NCT03400098 |
Available |
ATTR Expanded Access Program (EAP) by Ionis |
|
|
Expanded Access |
|
- Ionis Pharmaceuticals, Inc.
- Clinigen Group PLC
|
Industry / Other |
|
|
|
All |
18 Years and older (Adult, Senior) |
NCT03400098 |
ISIS 420915-CS5 |
|
|
|
|
January 17, 2018 |
April 4, 2018 |
|
- Mayo Clinic Cancer Center
Scottsdale, Arizona, United States - University of California - Irvine
Irvine, California, United States - Cedars-Sinai
Los Angeles, California, United States - (and 20 more...)
|
| 49 |
NCT03044353 |
Active, not recruiting |
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698 |
|
- Drug: GSK2315698 (CPHPC)
- Biological: GSK2398852 (anti-SAP mAb)
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in left ventricular (LV) mass over time up to 8-week follow-up
- Number of subjects with any adverse events (AEs) and any serious adverse events (SAEs)
- Number of subjects with abnormal haematology values
- (and 24 more...)
|
3 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03044353 |
201464 |
|
July 10, 2017 |
October 12, 2017 |
April 27, 2021 |
February 7, 2017 |
March 30, 2018 |
|
- GSK Investigational Site
Boston, Massachusetts, United States - GSK Investigational Site
Cambridge, United Kingdom - GSK Investigational Site
London, United Kingdom
|
| 50 |
NCT01604122 |
Completed
Has Results |
Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers |
- Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP)
- Transthyretin Cardiomyopathy (TTR-CM)
- Familial Amyloid Cardiomyopathy
- Senile Systemic Amyloidosis (SSA)
|
|
Observational |
|
|
Industry |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- Demographical Characteristics of Participants
- Disease Characteristics of Participants: Disease Duration
- Disease Characteristics of Participants: Mutation Type
- (and 26 more...)
|
1 |
|
Child, Adult, Senior |
NCT01604122 |
B3461036 |
|
April 18, 2012 |
July 27, 2015 |
July 18, 2016 |
May 23, 2012 |
April 12, 2017 |
April 12, 2017 |
|
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