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ConTTRibute: A Global Observational Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

Study acronym: ConTTRibute
StatusRecruiting
PhaseNot specified
Started2020-11-23
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 64 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-04
Study Identification, Study Status v63
Re-verified, no change to tracked fields
2026-05-27
Study Status, Outcome Measures v62
Primary endpoint(s) modified10 entries, revised
WasHCP- Assessed Cardiopulmonary Exercise Testing (CPET) Performance, HCP-Assessed Cardiomyopathy, HCP-Assessed Familial Amyloidotic Polyneuropathy (FAP) Score, HCP-Assessed Neuropathy Impairment Score (NIS), Health Care Provider (HCP)-Assessed Polyneuropathy (PND) Disability Score, Incidence of Adverse Events, Kansas City Cardiomyopathy Questionnaire (KCCQ), Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Score, Rasch-built Overall Disability Scale (R-ODS), Selected Events of Interest in Patients with Hereditary Transthyretin-mediated (hATTR) Amyloidosis (ATTRv Amyloidosis)
NowHCP- Assessed Cardiopulmonary Exercise Testing (CPET) Performance, HCP-Assessed Cardiomyopathy, HCP-Assessed Familial Amyloidotic Polyneuropathy (FAP) Score, HCP-Assessed Neuropathy Impairment Score (NIS), Health Care Provider (HCP)-Assessed Polyneuropathy (PND) Disability Score, Incidence of Adverse Events, Kansas City Cardiomyopathy Questionnaire (KCCQ), Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Score, Rasch-built Overall Disability Scale (R-ODS), Selected Events of Interest in Patients with Hereditary Transthyretin-mediated (hATTR) or Wild-type Transthyretin-mediated (wtATTR) Amyloidosis (ATTRv Amyloidosis)
Primary completion pushed: 2030-09-01 → 2033-12-31
Completion pushed: 2030-09-01 → 2033-12-31
2026-03-30
2 amendments v60-v61
2 re-verifications since 2026-02-13, no change to tracked fields
2025-12-18
Study Status, Contacts/Locations v59
Study sitesdetails revised at 2 of 40 sites
2025-11-10
Study Status v58
Re-verified, no change to tracked fields
Show 44 earlier versions
2025-10-15
Study Status, Contacts/Locations v57
Study sitesdetails revised at 1 of 40 sites
2025-09-16
4 amendments v53-v56
4 re-verifications since 2025-06-16, no change to tracked fields
2025-05-12
Study Status, Contacts/Locations v52
Study sitesdetails revised at 1 of 40 sites
2025-02-11
2 amendments v50-v51
2 re-verifications since 2025-01-08, no change to tracked fields
2024-12-06
Study Status, Contacts/Locations v49
Study sites39→40
2024-11-12
Study Status, Contacts/Locations v48
Study sites38→39
2024-10-02
2 amendments v46-v47
2 re-verifications since 2024-09-06, no change to tracked fields
2024-08-19
Study Status, Contacts/Locations v45
Study sites36→38
2024-08-09
Study Status v44
Re-verified, no change to tracked fields
2024-07-18
Study Status v43
Primary completion date2030-09→2030-09-01
Completion date2030-09→2030-09-01
2024-06-25
Study Status v42
Re-verified, no change to tracked fields
2024-05-09
Study Status, Contacts/Locations v41
Study sites35→36
2024-04-17
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v40
Eligibility criteria-1 characters
Inclusion Criteria: Diagnosis of ATTR amyloidosis or documented known disease-causing TTR mutationvariant for the cohort of pre-symptomatic carriers Germany Only: Pa [...]
Primary endpoints9 to 10 entries
HCP- Assessed Cardiopulmonary Exercise Testing (CPET) Performance HCP-Assessed Neuropathy Impairment Score of the Lower Limb (NIS-LL) Score
Study sitesdetails revised at 1 of 35 sites
2024-03-08
2 amendments v38-v39
2 re-verifications since 2024-02-12, no change to tracked fields
2024-02-01
Study Status, Contacts/Locations v37
Study sites33→35
2023-12-12
Study Status, Contacts/Locations v36
Study sites31→33
2023-11-14
Study Status, Contacts/Locations v35
Study sites30→31
2023-10-20
Study Status v34
Re-verified, no change to tracked fields
2023-09-12
Study Status, Contacts/Locations v33
Study sites29→30
2023-08-16
Study Status, Contacts/Locations v32
Study sites26→29
2023-05-15
Study Status, Contacts/Locations v31
Study sites25→26
2023-04-15
Study Status v30
Re-verified, no change to tracked fields
2023-03-20
Study Status, Contacts/Locations v29
Study sites24→25
2023-02-15
6 amendments v23-v28
6 re-verifications since 2022-09-13, no change to tracked fields
2022-08-15
Study Status, Contacts/Locations v22
Study sites23→24
2022-07-15
Study Status, Contacts/Locations v21
Study sites22→23
2022-06-02
Study Status v20
Re-verified, no change to tracked fields
2022-05-12
Study Status, Contacts/Locations v19
Study sites20→22
2022-04-11
Study Status, Contacts/Locations v18
Study sites19→20
2022-03-10
Study Status, Contacts/Locations v17
Study sites18→19
2022-02-14
Study Status, Contacts/Locations v16
Study sites14→18
2022-01-12
Study Status, Contacts/Locations v15
Study sites12→14
2021-12-13
Study Status, Contacts/Locations v14
Study sites10→12
The purpose of this study is to: * Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients * Characterize the safety and effectiveness of patisiran and vutrisiran as part of routine clinical practice in the real-world clinical setting * Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) variant
Trial Details
NCT Number NCT04561518
Lead Sponsor Alnylam Pharmaceuticals
Conditions Transthyretin-Mediated Amyloidosis, ATTR Amyloidosis
Enrollment 1,500 participants
Start Date 2020-11-23
Primary Completion 2033-12-31 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-08