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The Effects Of Fx-1006A On Transthyretin Stabilization And Clinical Outcome Measures In Patients With V122I Or Wild-Type TTR Amyloid Cardiomyopathy

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
Emory University School of Medicine
Atlanta, Georgia, 30322 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiomyopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Patient is > 40 years-old.

2. Patient participated in FoldRx Study Fx-001 (TRACS) OR Patient has documented TTR
amyloid cardiomyopathy and NYHA Classification of I or II.

TTR amyloid cardiomyopathy is defined as:

1. Variant TTR amyloid cardiomyopathy as defined as: V122I genotype and presence of
amyloid in cardiac biopsy tissue (as determined by congo red stain, alcin blue
stain, or immunohistochemical TTR analysis), or

2. Variant TTR amyloid cardiomyopathy as defined as: V122I genotype, evidence of
cardiac involvement by echocardiography with left ventricle wall thickness > 12
mm and presence of amyloid in non-cardiac biopsy tissue (as determined by congo
red stain, alcin blue stain, or immunohistochemical TTR analysis), or

3. Wild-type TTR amyloid cardiomyopathy as defined as: normal TTR genotype and
presence of TTR amyloid deposits in cardiac biopsy tissue (as determined by congo
red stain and immunohistochemical TTR analysis), or

4. Wild-type TTR amyloid cardiomyopathy as defined as: normal TTR genotype, evidence
of cardiac involvement by echocardiography with left ventricle wall thickness >
12 mm and presence of TTR amyloid deposits in non-cardiac biopsy tissue (as
determined by congo red stain and immunohistochemical TTR analysis).

3. Patient's symptoms of congestive heart failure (CHF) have been optimally managed prior
to baseline, as assessed by the Principal Investigator. Optimal CHF management
includes stable drug regimen for ≥ 4 weeks prior to enrollment and stable dose of beta
blocker for ≥ 3 months prior to enrollment.

4. If female, patient is post-menopausal. If male with a female partner of childbearing
potential, willing to use an acceptable method of birth control for the duration of
the study and for at least 3 months after the last dose of study medication.

5. Patient is, in the opinion of the Investigator, willing and able to comply with the
study medication regimen and all other study requirements

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs),
defined as greater than 3-4 times/month. The following NSAID are allowed:
acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone,
naproxen, nimesulide, piroxicam, and sulindac.

2. Patient has a TTR mutation other than V122I.

3. Patient has primary or secondary amyloidosis.

4. Patient has received prior liver or heart transplantation.

5. Patient with positive results for hepatitis B surface antigen (HBsAg), anti-hepatitis
C virus (anti-HCV), and/or human immunodeficiency virus (HIV).

6. Patient has renal failure requiring dialysis.

7. Patient has moderate or severe hepatic impairment (assessed by Child-Pugh).

8. Patient has liver function test abnormalities: alanine transaminases (ALT) and/or
aspartate transaminases (AST) > 2 times upper limit of normal (ULN) that, in the
medical judgment of the Investigator, are due to reduced liver function or active
liver disease.

9. Patient has prior non-amyloid cardiac disease, such as myocardial infarction due to
obstructive coronary artery disease, active non-amyloid cardiomyopathy (i.e.,
symptomatic left ventricular dysfunction from any cause other than amyloid), or
symptomatic valvular heart disease that significantly contribute to the patient's
underlying cardiac signs or symptoms.

10. Patient has a co-morbidity anticipated to limit survival to less than 12 months.

11. Patient received an investigational drug/device in another clinical investigational
study within 60 days before Baseline (Day 0).

12. Patient had active alcohol or substance abuse within 60 days before Baseline (Day 0).

13. Patient has a history of documented noncompliance.

NCT00694161
Pfizer
Completed
The Effects Of Fx-1006A On Transthyretin Stabilization And Clinical Outcome Measures In Patients With V122I Or Wild-Type TTR Amyloid Cardiomyopathy

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