CompletedPhase 3

The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)

United States211 participantsStarted 2015-07-16

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Have completed a patisiran study (i.e., completed the last efficacy visit in the parent study) and, in the opinion of the investigator, tolerated study drug * Be willing and able to comply with the protocol-required visit schedule and visit requirements and provide written informed consent Exclusion Criteria: * Any new or uncontrolled condition that could make the participant unsuitable for participation

What they're measuring

Percentage of Participants With Adverse Events (AEs) Leading to Study Discontinuation

Timeframe: First dose up to 28 days after last dose of study drug (approximately 5.6 years)

Trial details

NCT IDNCT02510261

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-23

Results submitted2023-11-16

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