Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05568719 | Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively | PHASE3 | RECRUITING | 173 | — | — | Dec 28, 2022 | Feb 25, 2040 | May 27, 2026 | 23 | United States, Australia +5 |
FIX inhibitor development was defined as an inhibitor titer \>= 0.6 Bethesda units per milliliter (BU/mL).
Factor activity level will be reported. Factor levels may be measured using different assay methods including a one-stage assay or by chromogenic substrate assay and a second one-stage assay.
| Arm | Type | Description |
|---|---|---|
| Hemophilia A / giroctocogene fitelparvovec | OTHER | Participants have received treatment with giroctocogene fitelparvovec in a previous study and are not receiving any investigational product in this study |
| Hemophilia B / fidanacogene elaparvovec | OTHER | Participants have received treatment with fidanacogene elaparvovec in a previous study and are not receiving any investigational product in this study |
| Name | Type | Description |
|---|---|---|
| Testing of hepatic AAV Vector integration | DIAGNOSTIC_TEST | Evaluation of AAV vector integration in participants for whom a sample of liver has been obtained through biopsy or surgical resection when clinically indicated |
Inclusion Criteria: -Only participants who received investigational giroctocogene fitelparvovec or fidanacogene eleparvovec and were enrolled in a Pfizer-sponsored study (C0371002, C0371003, C0371005, C3731001, C3731003) are eligible. Exclusion Criteria: -None