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C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523660-21-00
Enrollment
7
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemophilia A, severe to moderately severe hemophilia B (FIX:C ≤ 2%)

Brief summary

Incidence of thromboembolic events, Incidence of factor inhibitor development, Incidence of hepatic malignancy, Incidence of liver abnormalities, Factor activity level

Detailed description

Total ABR (treated and untreated), Incidence of and time from previously administered gene therapy infusion to resumption of prophylaxis, AIR of exogenous factor, Consumption of exogenous factor, Incidence of Non-hepatic malignancy, Incidence of Auto-immune disorders, Incidence of SAEs, All cause-mortality, EQ-5D-5L dimension and VAS scores

Interventions

DRUGfidanacogene elaparvovec
DRUGgiroctocogene fitelparvovec

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Incidence of thromboembolic events, Incidence of factor inhibitor development, Incidence of hepatic malignancy, Incidence of liver abnormalities, Factor activity level—

Secondary

MeasureTime frame
Total ABR (treated and untreated), Incidence of and time from previously administered gene therapy infusion to resumption of prophylaxis, AIR of exogenous factor, Consumption of exogenous factor, Incidence of Non-hepatic malignancy, Incidence of Auto-immune disorders, Incidence of SAEs, All cause-mortality, EQ-5D-5L dimension and VAS scores—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 21, 2026