CompletedPhase 3

APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis

United States225 participantsStarted 2013-11

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.

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: * Male or female of 18 to 85 years of age (inclusive); * Have a diagnosis of FAP * Neuropathy Impairment Score requirement of 5-130 * Meet Karnofsky performance status requirements * Have adequate complete blood counts and liver function tests * Have adequate cardiac function * Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV) Exclusion Criteria: * Had a prior liver transplant or is planned to undergo liver transplant during the study period; * Has untreated hypo- or hyperthyroidism; * Has known human immunodeficiency virus (HIV) infection; * Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated; * Recently received an investigational agent or device * Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid

What they're measuring

Modified Neuropathy Impairment Score +7 (mNIS+7)

Timeframe: 18mo

Trial details

NCT IDNCT01960348

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08

Results submitted2018-08-07

View on ClinicalTrials.gov More TTR-mediated Amyloidosis trials