Status:
COMPLETED
An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy
Lead Sponsor:
Pfizer
Conditions:
Familial Amyloid Polyneuropathy
ATTR-PN
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed to determine the long-term safety and tolerability of Fx-1006A as well as the effects of Fx-1006A on clinical outcomes in patients with ATTR-PN. All patients who enroll in this...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00791492
Start Date
July 1 2008
End Date
October 1 2010
Last Update
December 17 2012
Active Locations (11)
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1
FLENI Departamento de Hepatología y Transplante de Organos
Buenos Aires, Argentina
2
FLENI-Hepatology and Organ Transplant Dept.
Ciudad de Buenos Aires, Argentina, C1428AQK
3
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, Brazil
4
Service de Neurologie, CHU Henri Mondor
Paris, France