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

Completed · Phase 3

Conditions studied: TTR-mediated Amyloidosis, Amyloidosis, Hereditary, Amyloid Neuropathies, Familial, Familial Amyloid Polyneuropathies, Amyloid Neuropathies, Amyloidosis, Hereditary, Transthyretin-Related

In brief

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.

Key facts

Study ID

NCT01960348

Run by

Alnylam Pharmaceuticals

People needed

225

Starts

2013-11-01

Expected to finish

2017-08-01

Last updated by the study team

2024-04-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Clinical Trial Site — Orange, California, United States
• Clinical Trial Site — Denver, Colorado, United States
• Clinical Trial Site — Chicago, Illinois, United States
• Clinical Trial Site — Baltimore, Maryland, United States
• Clinical Trial Site — Boston, Massachusetts, United States
• Clinical Trial Site — Detroit, Michigan, United States
• Clinical Trial Site — Rochester, Minnesota, United States
• Clinical Trial Site — St Louis, Missouri, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Trial Site — Durham, North Carolina, United States
• Clinical Trial Site — Portland, Oregon, United States
• Clinical Trial Site — Buenos Aires, Argentina
• Clinical Trial Site — Westmead, Australia
• Clinical Trial Site — Ribeirão Preto, Brazil
• Clinical Trial Site — Rio de Janeiro, Brazil
• Clinical Trial Site — São Paulo, Brazil
• Clinical Trial Site — Sofia, Bulgaria
• Clinical Trial Site — Vancouver, British Columbia, Canada
• Clinical Trial Site — Nicosia, Cyprus
• Clinical Trial Site — Bourdeaux, France
• Clinical Trial Site — Créteil, France
• Clinical Trial Site — Le Kremlin-Bicêtre, France
• Clinical Trial Site — Lille, France
• Clinical Trial Site — La Mesa, California, United States

Full record on ClinicalTrials.gov

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