Description:

ODM derived from http://clinicaltrials.gov/show/NCT00409175

Link:

http://clinicaltrials.gov/show/NCT00409175

Keywords:
Versions (1) ▾
  1. 12/9/13
Uploaded on:

December 9, 2013

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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00409175 Familial Amyloid Polyneuropathy

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 75 Years
Amyloid documented by biopsy.
Documented V30M TTR mutation.
Peripheral and/or autonomic neuropathy with a Karnofsky Performance Status ≥50.
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.
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
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs).
AL amyloidosis, Idiopathic amyloidosis
If female, patient is pregnant or breast feeding.
Prior liver transplantation.
No recordable sensory threshold for vibration perception in both feet, as measured by CASE IV.
Positive results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).
Renal insufficiency or liver function test abnormalities.
New York Heart Association (NYHA) Functional Classification ≥III.
Other causes of sensorimotor neuropathy (B12 deficiency, Diabetes Mellitus, HIV treated with retroviral medications, thyroid disorders, alcohol abuse, and chronic inflammatory diseases).
Co-morbidity anticipated to limit survival to < 18 months.
Patient received an investigational drug/device and/or participated in another clinical investigational study within 60 days before Baseline.