The Phase 2 Study of an Investigational Drug, ALN-TTRSC, in Patients with TTR Cardiac Amyloidosis

• Conditions: Transthyretin (TTR) Cardiac Amyloidosis; MedDRA version: 16.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-002856-33-GB
• Lead Sponsor: Alnylam Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-03
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Males or females 18 to 80 years of age, inclusive;
Biopsy-proven TTR cardiac amyloidosis
NYHA Class =3
Stable congestive heart failure status and stable clinical treatment
Able to walk =150 meters

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Uncontrolled hypertension;
Uncontrolled ischemic heart disease;
Uncontrolled clinically significant cardiac arrhythmia;
Untreated hypo- or hyperthyroidism
Prior major organ transplant;
Known or suspected systemic bacterial, viral, parasitic, or fungal infection;
Seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV) or known to be human immunodeficiency virus (HIV) positive;
Received an investigational agent other than tafamidis, diflunisal, doxycycline or tauroursodeoxycholic acid, or an investigational device within 30 days prior to first dose of study drug;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified