Observational study of patients with ATTR amyloidosis
ConTTRibute: A Global Observational Multicenter Long-Term Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)
This study looks at the characteristics of people with ATTR amyloidosis and tests how well existing treatments work for them in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 40 sites (La Jolla, California and 39 other locations) |
| Trial ID | NCT04561518 on ClinicalTrials.gov |
What this trial studies
This study aims to describe the epidemiological and clinical characteristics of patients with transthyretin-mediated amyloidosis (ATTR amyloidosis). It will also evaluate the safety and effectiveness of existing treatments, patisiran and vutrisiran, in real-world clinical settings. Additionally, the study will monitor disease progression in individuals who are pre-symptomatic carriers of known disease-causing TTR variants. The research will be conducted in Germany and select sites in the United States.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with ATTR amyloidosis or pre-symptomatic carriers of known TTR variants.
Not a fit: Patients currently enrolled in clinical trials for investigational agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ATTR amyloidosis and improve management strategies for patients.
How similar studies have performed: Other studies have shown success in characterizing ATTR amyloidosis, but this observational approach may provide novel insights into real-world management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of ATTR amyloidosis or documented known disease-causing TTR variant for the cohort of pre-symptomatic carriers * Germany Only: Patients must be treated per the summary of product characteristics (SmPC) for any approved treatment for ATTR amyloidosis Exclusion Criteria: * Current enrollment in a clinical trial for any investigational agent
Where this trial is running
La Jolla, California and 39 other locations
- Clinical Trial Site — La Jolla, California, United States (Recruiting)
- Clinical Trial Site — Los Angeles, California, United States (Recruiting)
- Clinical Trial Site — Jacksonville, Florida, United States (Recruiting)
- Clinical Trial Site — Iowa City, Iowa, United States (Recruiting)
- Clinical Trial Site — Kansas City, Kansas, United States (Recruiting)
- Clinical Trial Site — Baltimore, Maryland, United States (Recruiting)
- Clinical Trial Site — Boston, Massachusetts, United States (Completed)
- Clinical Trial Site — New York, New York, United States (Recruiting)
- Clinical Trial Site — Durham, North Carolina, United States (Recruiting)
- Clinical Trial Site — Columbus, Ohio, United States (Recruiting)
- Clinical Trial Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Clinical Trial Site — Austin, Texas, United States (Recruiting)
- Clinical Trial Site — Houston, Texas, United States (Recruiting)
- Clinical Trial Site — Salvador, Brazil (Recruiting)
- Clinical Trial Site — São Paulo, Brazil (Recruiting)
- Clinical Trial Site — Sofia, Bulgaria (Recruiting)
- Clinical Trial Site — Aarhus, Denmark (Recruiting)
- Clinical Trial Site — Copenhagen, Denmark (Completed)
- Clinical Trial Site — Bordeaux, France (Recruiting)
- Clinical Trial Site — Bron, France (Recruiting)
- Clinical Trial Site — Créteil, France (Recruiting)
- Clinical Trial Site — Le Kremlin-Bicêtre, France (Recruiting)
- Clinical Trial Site — Marseille, France (Recruiting)
- Clinical Trial Site — Berlin, Germany (Recruiting)
- Clinical Trial Site — Giessen, Germany (Recruiting)
- Clinical Trial Site — Hanover, Germany (Recruiting)
- Clinical Trial Site — Jerusalem, Israel (Recruiting)
- Clinical Trial Site — Ramat Gan, Israel (Recruiting)
- Clinical Trial Site — Milan, Italy (Recruiting)
- Clinical Trial Site — Naples, Italy (Recruiting)
- Clinical Trial Site — Palermo, Italy (Recruiting)
- Clinical Trial Site — Roma, Italy (Recruiting)
- Clinical Trial Site — Groningen, Netherlands (Recruiting)
- Clinical Trial Site — Lisbon, Portugal (Recruiting)
- Clinical Trial Site — Porto, Portugal (Recruiting)
- Clinical Trial Site — Barcelona, Spain (Recruiting)
- Clinical Trial Site — Madrid, Spain (Recruiting)
- Clinical Trial Site — Palma, Spain (Recruiting)
- Clinical Trial Site — New Taipei City, Taiwan (Recruiting)
- Clinical Trial Site — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Alnylam Clinical Trial Information Line
- Email: clinicaltrials@alnylam.com
- Phone: 1-877-ALNYLAM
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.