APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
NCT ID: NCT01960348
Last Updated: 2024-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2013-11-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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patisiran (ALN-TTR02)
patisiran (ALN-TTR02)
administered by intravenous (IV) infusion
Sterile Normal Saline (0.9% NaCl)
Sterile Normal Saline (0.9% NaCl)
administered by intravenous (IV) infusion
Interventions
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patisiran (ALN-TTR02)
administered by intravenous (IV) infusion
Sterile Normal Saline (0.9% NaCl)
administered by intravenous (IV) infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jared Gollob
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
La Mesa, California, United States
Clinical Trial Site
Orange, California, United States
Clinical Trial Site
Denver, Colorado, United States
Clinical Trial Site
Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Portland, Oregon, United States
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Buenos Aires, , Argentina
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Westmead, , Australia
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Ribeirão Preto, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Sofia, , Bulgaria
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Vancouver, British Columbia, Canada
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Nicosia, , Cyprus
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Bourdeaux, , France
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Créteil, , France
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Le Kremlin-Bicêtre, , France
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Lille, , France
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Marseille, , France
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Heidelberg, , Germany
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Münster, , Germany
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Regensburg, , Germany
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Pavia, , Italy
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Rome, , Italy
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Sicily, , Italy
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Matsumoto, Nagano, Japan
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Aichi, , Japan
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Kumamoto, , Japan
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Kuala Lumpur, , Malaysia
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Mexico City, , Mexico
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Groningen, , Netherlands
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Lisbon, , Portugal
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Porto, , Portugal
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Huelva, , Spain
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Madrid, , Spain
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Palma de Mallorca, , Spain
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Umeå, , Sweden
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Taipai, , Taiwan
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Taipei, , Taiwan
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Istanbul, , Turkey (Türkiye)
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London, , United Kingdom
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London, , United Kingdom
Countries
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References
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Lin KP, Yang CC, Lee YC, Lee MJ, Vest J, Sweetser MT, White MT, Badri P, Hsieh ST, Chao CC. Patisiran, an RNAi therapeutic for hereditary transthyretin-mediated amyloidosis: Sub-analysis in Taiwanese patients from the APOLLO study. J Formos Med Assoc. 2024 Sep;123(9):975-984. doi: 10.1016/j.jfma.2024.03.008. Epub 2024 Mar 27.
Quan D, Obici L, Berk JL, Ando Y, Aldinc E, White MT, Adams D. Impact of baseline polyneuropathy severity on patisiran treatment outcomes in the APOLLO trial. Amyloid. 2023 Mar;30(1):49-58. doi: 10.1080/13506129.2022.2118043. Epub 2022 Sep 18.
Zhang X, Goel V, Attarwala H, Sweetser MT, Clausen VA, Robbie GJ. Patisiran Pharmacokinetics, Pharmacodynamics, and Exposure-Response Analyses in the Phase 3 APOLLO Trial in Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis. J Clin Pharmacol. 2020 Jan;60(1):37-49. doi: 10.1002/jcph.1480. Epub 2019 Jul 19.
Minamisawa M, Claggett B, Adams D, Kristen AV, Merlini G, Slama MS, Dispenzieri A, Shah AM, Falk RH, Karsten V, Sweetser MT, Chen J, Riese R, Vest J, Solomon SD. Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study. JAMA Cardiol. 2019 May 1;4(5):466-472. doi: 10.1001/jamacardio.2019.0849.
Solomon SD, Adams D, Kristen A, Grogan M, Gonzalez-Duarte A, Maurer MS, Merlini G, Damy T, Slama MS, Brannagan TH 3rd, Dispenzieri A, Berk JL, Shah AM, Garg P, Vaishnaw A, Karsten V, Chen J, Gollob J, Vest J, Suhr O. Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis. Circulation. 2019 Jan 22;139(4):431-443. doi: 10.1161/CIRCULATIONAHA.118.035831.
Adams D, Gonzalez-Duarte A, O'Riordan WD, Yang CC, Ueda M, Kristen AV, Tournev I, Schmidt HH, Coelho T, Berk JL, Lin KP, Vita G, Attarian S, Plante-Bordeneuve V, Mezei MM, Campistol JM, Buades J, Brannagan TH 3rd, Kim BJ, Oh J, Parman Y, Sekijima Y, Hawkins PN, Solomon SD, Polydefkis M, Dyck PJ, Gandhi PJ, Goyal S, Chen J, Strahs AL, Nochur SV, Sweetser MT, Garg PP, Vaishnaw AK, Gollob JA, Suhr OB. Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):11-21. doi: 10.1056/NEJMoa1716153.
Adams D, Suhr OB, Dyck PJ, Litchy WJ, Leahy RG, Chen J, Gollob J, Coelho T. Trial design and rationale for APOLLO, a Phase 3, placebo-controlled study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy. BMC Neurol. 2017 Sep 11;17(1):181. doi: 10.1186/s12883-017-0948-5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-002987-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-TTR02-004
Identifier Type: -
Identifier Source: org_study_id
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