Status:
COMPLETED
Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Transthyretin Mediated Amyloidosis (ATTR)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated amyloidosis (ATTR)...
Eligibility Criteria
Inclusion
- Diagnosis of TTR amyloidosis
- Adequate blood counts, liver and renal function
- Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control
- Males agree to use appropriate contraception
- Willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent.
Exclusion
- Known human immunodeficiency virus (HIV) positive status
- Receiving antibiotics for bacterial infection within 7 days of screening
- Known or suspected systemic viral, parasitic or fungal infection
- Receiving an investigational agent within 30 days prior to study drug administration
- Poor cardiac function
- Considered unfit for the study by the Principal Investigator
- Known sensitivity to oligonucleotides
- Employee or family member of the sponsor or the clinical study site personnel.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01148953
Start Date
June 1 2010
End Date
February 1 2012
Last Update
May 24 2012
Active Locations (4)
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1
Clinical Site
Le Kremlin-Bicêtre, France, 94275
2
Clinical Site
Porto, Portugal, 4099-001
3
Clinical Site
Umeå, Sweden, SE 901 85
4
Clinical Site
London, United Kingdom, SE1 1YR