Clinical Trial: Trial to Evaluate Safety and Tolerability of ALN-TTR02 in Transthyretin (TTR) Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients With TTR
Brief Summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ALN-TTR02 in patients with transthyretin (TTR) mediated amyloidosis (ATTR).
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: Safety and tolerability in ATTR patients [ Time Frame: Up to 56 Days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK) of ALN-TTR02 [ Time Frame: Up to 208 days ]Cmax, Area Under Curve, Tmax
- Serum transthyretin (TTR) protein [ Time Frame: Up to 208 days ]Determination of % Lowering to pretreatment/Baseline Levels
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: June 7, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 22, 2014
Last Verified: April 2014