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Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
MGH Neuropathy Laboratory
Boston, Massachusetts, 02114 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Familial Amyloid Polyneuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Amyloid documented by biopsy.

2. Documented V30M TTR mutation.

3. Peripheral and/or autonomic neuropathy with a Karnofsky Performance Status ≥50.

4. Patient is 18-75 years old.

5. If female, patient is post-menopausal, surgically sterilized, or willing to use an
acceptable method of birth control. If male with a female partner of childbearing
potential, willing to use an acceptable method of birth control for the duration of
the study. For both females and males, birth control must be used for at least 3
months after the last dose of study medication.

6. 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.
Show details

1. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs).

2. Primary amyloidosis.

3. If female, patient is pregnant or breast feeding.

4. Prior liver transplantation.

5. No recordable sensory threshold for vibration perception in both feet, as measured by
CASE IV.

6. Positive results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus
(HCV), and/or human immunodeficiency virus (HIV).

7. Renal insufficiency or liver function test abnormalities.

8. New York Heart Association (NYHA) Functional Classification ?III.

9. Other causes of sensorimotor neuropathy (B12 deficiency, Diabetes Mellitus, HIV
treated with retroviral medications, thyroid disorders, alcohol abuse, and chronic
inflammatory diseases).

10. Co-morbidity anticipated to limit survival to less than 18 months.

11. Patient received an investigational drug/device and/or participated in another
clinical investigational study within 60 days before Baseline.

NCT00409175
Pfizer
Completed
Safety and Efficacy Study of Fx-1006A in Patients With Familial Amyloidosis

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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