Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis

TTR-mediated Amyloidosis Clinical Trial

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 Amyloidosis

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01617967
Study type	Interventional
Source	Alnylam Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	May 2012
Completion date	January 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02292186` - A Extension Study to Evaluate Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Cardiac Amyloidosis	Phase 2
Completed	`NCT01961921` - The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)	Phase 2
Completed	`NCT01960348` - APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis	Phase 3
Completed	`NCT01814839` - A Phase 1, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC (Revusiran) in Healthy Volunteers	Phase 1
Completed	`NCT01559077` - Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer Subjects	Phase 1
Completed	`NCT01981837` - Phase 2 Study to Evaluate ALN-TTRSC (Revusiran) in Patients With Transthyretin (TTR) Cardiac Amyloidosis	Phase 2
Approved for marketing	`NCT02939820` - Expanded Access Protocol of Patisiran for Patients With Hereditary ATTR Amyloidosis (hATTR)