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A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

StatusRecruiting
PhasePhase 1/2
Started2026-09-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jul 31, 2031 → Apr 30, 2032
See other at-risk trials from Roche/Genentech

Amendment history

2026-09-10
Study Status v12
Primary completion pushed: 2031-07-31 → 2032-04-30
Completion pushed: 2031-07-31 → 2032-04-30
Start dateestimated 2026-09-01→confirmed 2026-09-08
2026-08-03
Study Status, Contacts/Locations v11
Start date2026-07-14→2026-09-01
Study sites2→3
2026-07-13
Study Status v10
Start date2026-06-30→2026-07-14
2026-06-19
Study Status, Contacts/Locations, References v9
2026-05-22
Study Status v8
Start date2026-05-15→2026-06-30
2026-04-24
Study Status, Contacts/Locations v7
Recruitment opened
Start date2026-03-31→2026-05-15
Study sites1→2
2026-03-26
Study Status, Contacts/Locations v6
Trial status changed: Recruiting → Not Yet Recruiting
Study sitesdetails revised at 1 of 1 site
2026-03-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2026-02-27
Study Status v4
Primary completion date2031-01-30→2031-07-31
Completion date2031-01-30→2031-07-31
Start date2026-01-30→2026-03-31
2026-01-29
Study Status, Study Design v3
PhasePhase 2→Phase 1/2
2026-01-05
2 amendments v1-v2
2 re-verifications since 2025-12-05, no change to tracked fields
2025-11-06
Original filing
Roche/Genentech
364 trials monitored
See 34 trials at risk
Hemophilia
231 trials monitored
See 10 trials at risk
This study will assess the safety and tolerability of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.
Trial Details
NCT Number NCT07226206
Lead Sponsor Hoffmann-La Roche
Conditions Hemophilia A
Enrollment 5 participants
Start Date 2026-09-08
Primary Completion 2032-04-30 (estimated)
Study Completion 2032-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-11