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ATTR cardiomyopathy (ATTR-CM) for Amyloidosis (MaesTTRo Trial)

N/A
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Summary

The MaesTTRo study aims to enroll a global cohort of patients with transthyretin (ATTR) amyloidosis to longitudinally observe the natural course of the disease and describe real-world treatment patterns and outcomes. In addition, information on the effectiveness of ATTR amyloidosis treatments, including eplontersen, which is a ligand-conjugated antisense oligonucleotide gene silencing treatment targeting activity against both the mutant and wild-type TTR protein, will be collected.

Eligible Conditions
  • Transthyretin Amyloidosis
  • Amyloidosis
  • Cardiomyopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary score (overall and in patients initiating a treatment with eplontersen)
Biomarker results (overall and in patients initiating a treatment with eplontersen)
Clinical characteristics (overall and in patients initiating a treatment with eplontersen)
+17 more
Secondary study objectives
Comparison of Clinical manifestations (signs and symptoms) of ATTR amyloidosis in patients prescribed eplontersen to patients on other ATTR treatments
Comparison of ECG variables of patients prescribed eplontersen at any time during the observation period to patients on other ATTR treatments
Comparison of Familial amyloid polyneuropathy (FAP) (Coutinho) staging in patients prescribed eplontersen to patients on other ATTR treatments
+9 more
Other study objectives
Risk factors for worsening ATTR progression

Trial Design

3Treatment groups
Experimental Treatment
Group I: Hereditary polyneuropathy (ATTRv-PN)Experimental Treatment1 Intervention
Patients with ATTRv-PN at enrollment
Group II: ATTR-MixedExperimental Treatment1 Intervention
Patients with a mixed ATTR amyloidosis phenotype
Group III: ATTR cardiomyopathy (ATTR-CM)Experimental Treatment1 Intervention
Patients with ATTR-CM at enrollment

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,645,209 Total Patients Enrolled
10 Trials studying Amyloidosis
59,660 Patients Enrolled for Amyloidosis
ICON plcIndustry Sponsor
84 Previous Clinical Trials
25,669 Total Patients Enrolled
~1067 spots leftby Jun 2031
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