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An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy

Last updated on February 18, 2019

FOR MORE INFORMATION
Study Location
FLENI Departamento de Hepatología y Transplante de Organos
Buenos Aires, , Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Familial Amyloid Polyneuropathy, ATTR-PN
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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Male and non-pregnant female patients meeting all of the following criteria are eligible
for enrollment in this study:

- Patient has completed the Month 18 visit of Study Fx-005.

- If female, patient is post-menopausal, surgically sterilized, or willing to use an
acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide) throughout the study. (A
condom alone is not considered 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, acceptable birth
control must be used for at least 3 months after the last dose of study medication.

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

- Patient agrees not to participate in another investigational drug or device study
while participating in this open-label extension study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Patients meeting any of the exclusion criteria will not be enrolled in the study:

- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than
3-4 times/month (ibuprofen and nimesulide will be permitted).

- If female, patient is pregnant or breast feeding.

- 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.

NCT00791492
Pfizer
Completed
An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now