BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

Study acronym: BONAPH1DE

StatusActive, Not Recruiting

PhaseNot specified

SponsorAlnylam Pharmaceuticals

Started2021-12-13

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary completion moved at least 4 months later Sep 1, 2028 → Jan 2, 2029

See other at-risk trials from Alnylam Pharmaceuticals

Amendment history

2026-09-04

Study Identification, Study Status v48

Primary completion pushed: 2028-09-01 → 2029-01-02

Completion pushed: 2028-09-01 → 2029-01-02

2026-04-23

3 amendments v45-v47

3 re-verifications since 2026-02-13, no change to tracked fields

2025-12-18

Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v44

Trial statusRecruiting→Active, Not Recruiting

Enrollment targetestimated 200→confirmed 207

Study sitesdetails revised at 30 of 30 sites

2025-11-10

2 amendments v42-v43

2 re-verifications since 2025-10-15, no change to tracked fields

2025-09-16

Study Status, Contacts/Locations v41

Study sitesdetails revised at 2 of 30 sites

Show 40 earlier versions

2025-05-09

4 amendments v37-v40

4 re-verifications since 2024-12-05, no change to tracked fields

2024-11-07

Study Status, Contacts/Locations v36

Study sites28→30

2024-10-02

Study Status, Contacts/Locations v35

Study sites27→28

2024-09-06

Study Status, Contacts/Locations v34

Study sites26→27

2024-08-09

Study Status, Contacts/Locations v33

Study sites25→26

2024-07-18

Study Status v32

Primary completion date2028-09→2028-09-01

Completion date2028-09→2028-09-01

2024-06-25

Study Status, Contacts/Locations v31

Study sites24→25

2024-05-09

Study Status v30

Re-verified, no change to tracked fields

2024-04-17

Study Status, Contacts/Locations v29

Study sites23→24

2024-03-08

Study Status, Contacts/Locations v28

Study sites21→23

2024-02-12

Study Status, Contacts/Locations v27

Study sites20→21

2024-02-01

Study Status, Contacts/Locations v26

Study sites19→20

2023-12-13

Study Status, Contacts/Locations v25

Study sites17→19

2023-11-14

Study Status, Contacts/Locations v24

Study sites15→17

2023-10-20

6 amendments v18-v23

6 re-verifications since 2023-03-20, no change to tracked fields

2023-01-13

Study Status, Contacts/Locations v17

Study sites14→15

2022-12-14

Study Status, Contacts/Locations v16

Study sites13→14

2022-11-07

Study Status, Contacts/Locations v15

Study sites11→13

2022-10-19

2 amendments v13-v14

2 re-verifications since 2022-09-12, no change to tracked fields

2022-08-11

Study Status, Contacts/Locations v12

Study sites9→11

2022-07-14

Study Status, Contacts/Locations v11

Study sites7→9

2022-06-02

2 amendments v9-v10

2 re-verifications since 2022-05-06, no change to tracked fields

2022-04-11

Study Status, Contacts/Locations v8

Study sites6→7

2022-03-10

Study Status, Contacts/Locations v7

Study sites5→6

2022-02-14

Study Status, Contacts/Locations v6

Study sites4→5

2022-01-12

Study Status v5

Start dateestimated 2021-12→confirmed 2021-12-13

2021-12-13

Study Status, Contacts/Locations v4

Start date2021-11→2021-12

Study sites2→4

2021-11-09

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3

Trial statusNot Yet Recruiting→Recruiting

Start date2021-10-31→2021-11

Study sites1→2

2021-10-14

Study Status, Contacts/Locations v2

Start date2021-09-30→2021-10-31

Study sites0→1

2021-09-15

Study Status v1

Start date2021-07-31→2021-09-30

2021-07-20

Original filing

Alnylam Pharmaceuticals

31 trials monitored

See 5 trials at risk

The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.

Trial Details

NCT Number	NCT04982393
Lead Sponsor	Alnylam Pharmaceuticals
Conditions	Primary Hyperoxaluria Type 1
Enrollment	207 participants
Start Date	2021-12-13
Primary Completion	2029-01-02 (estimated)
Study Completion	2029-01-02 (estimated)
Updated on ClinicalTrials.gov	2026-09-08