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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01960348
First received: October 9, 2013
Last updated: October 17, 2016
Last verified: October 2016
October 9, 2013
October 17, 2016
November 2013
July 2017   (Final data collection date for primary outcome measure)
The difference between the ALN TTR02 and placebo groups in the change from baseline of modified Neuropathy Impairment Score+7 (mNIS+7) [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT01960348 on ClinicalTrials.gov Archive Site
  • The difference between ALN-TTR02 and placebo in the change from baseline in quality of life [ Time Frame: 18 months ]
  • The difference between ALN-TTR02 and placebo in the change from baseline in motor function [ Time Frame: 18 months ]
  • The difference between ALN-TTR02 and placebo in the change from baseline in autonomic function [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
 
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneuropathy (Familial Amyloidotic Polyneuropathy-FAP)
The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in patients with transthyretin (TTR) mediated amyloidosis
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
  • TTR-mediated Amyloidosis
  • Amyloidosis, Hereditary
  • Amyloid Neuropathies, Familial
  • Familial Amyloid Polyneuropathies
  • Amyloid Neuropathies
  • Amyloidosis, Hereditary, Transthyretin-Related
  • Drug: patisiran (ALN-TTR02)
    administered by intravenous (IV) infusion
  • Drug: Sterile Normal Saline (0.9% NaCl)
    administered by intravenous (IV) infusion
  • Active Comparator: patisiran (ALN-TTR02)
    Intervention: Drug: patisiran (ALN-TTR02)
  • Placebo Comparator: Sterile Normal Saline (0.9% NaCl)
    Intervention: Drug: Sterile Normal Saline (0.9% NaCl)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
225
August 2017
July 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Cyprus,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Portugal,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
 
 
NCT01960348
ALN-TTR02-004
2013-002987-17 ( EudraCT Number )
Yes
Not Provided
Not Provided
Not Provided
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
Not Provided
Study Director: Jared Gollob Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP