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Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis

Last updated on March 14, 2019

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Study Location
Johns Hopkins Hospital
Baltimore, Maryland, 21287 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ATTR-PN
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patient has successfully completed either Protocol Fx-006 or Fx1A-201.

- If female, patient is post-menopausal, surgically sterilized, or willing to use two
acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide) throughout the study and
for 3 months from the end of the study. (A condom alone is not considered an
acceptable method of birth control.)

- Patient is, in the opinion of the investigator, willing and able to comply with the
investigational product 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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- Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.

- Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs),
defined as greater than 3 to 4 times/month. The following NSAIDs are allowed:
acetylsalicylic acid, etodolac, ibuprofen, indomethicin, ketoprofen, nabumetone,
naproxen, nimesulide, piroxicam, and sulindac.

- If female, patient is pregnant or breast feeding.

- Clinically significant medical condition that, in the opinion of the investigator,
would place the patient at an increased risk to participate in the study.

- The patient has received a liver or heart transplant prior to enrollment.

NCT00925002
Pfizer
Active, not recruiting
Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis

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