Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
Completed · Phase 2
Conditions studied: TTR-mediated Amyloidosis
In brief
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
Key facts
- Study ID
- NCT01617967
- Run by
- Alnylam Pharmaceuticals
- People needed
- 29
- Starts
- 2012-05-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2024-04-19
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Body mass index must be between 17 kg/m\^2 and ≤ 33 kg/m\^2;
- Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use appropriate contraception;
- Males agree to use appropriate contraception;
- Diagnosis of TTR amyloidosis;
- Adequate blood counts, liver and renal function;
- Willing to give written informed consent and are willing to comply with the study requirements.
You may not qualify if…
- Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;
- Received an investigational agent, other than tafamidis or diflunisal, within 30 days prior to first dose study drug administration;
- Prior liver transplant;
- Poor cardiac function;
- Considered unfit for the study by the Principal Investigator;
- Employee or family member of the sponsor or the clinical study site personnel.
Where it is running
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Rio de Janeiro, Brazil
- Clinical Trial Site — Le Kremlin-Bicêtre, France
- Clinical Trial Site — Marseille, France
- Clinical Trial Site — Münster, Germany
- Clinical Trial Site — Lisbon, Portugal
- Clinical Trial Site — Porto, Portugal
- Clinical Trial Site — Barcelona, Spain
- Clinical Trial Site — Palma de Mallorca, Spain
- Clinical Trial Site — Umeå, Sweden
Full record on ClinicalTrials.gov
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