A low-interventional study to evaluate long-term effectiveness of real-world prophylactic treatment with efanesoctocog alfa on joint health in people with haemophilia A (ALTITUDE)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517812-31-00

Acronym

Sobi.BIVV001-005

Enrollment

175

Registered

2025-04-28

Start date

2025-05-21

Completion date

Unknown

Last updated

2025-08-29

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

Conditions

Haemophilia A

Brief summary

Annualised joint bleeding rate (AjBR) over the prospective period

Detailed description

1. Annual Bleeding Rate over the prospective observation period, 2. Number of injections and total dose to control a bleeding event over the prospective observation period, 3. Change in HJHS from enrolment to Months 12, 24 and 36, 4. Target joint development, resolution, and recurrency on a patient and joint level during the period on efanesoctocog alfa

Interventions

DRUGALTUVOCT 250 IU powder and solvent for solution for injection

DRUGALTUVOCT 3 000 IU powder and solvent for solution for injection

DRUGALTUVOCT 1 000 IU powder and solvent for solution for injection

DRUGALTUVOCT 500 IU powder and solvent for solution for injection

DRUGALTUVOCT 4 000 IU powder and solvent for solution for injection

DRUGALTUVOCT 2 000 IU powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualised joint bleeding rate (AjBR) over the prospective period	—

Secondary

Measure	Time frame
1. Annual Bleeding Rate over the prospective observation period, 2. Number of injections and total dose to control a bleeding event over the prospective observation period, 3. Change in HJHS from enrolment to Months 12, 24 and 36, 4. Target joint development, resolution, and recurrency on a patient and joint level during the period on efanesoctocog alfa	—

Countries

Croatia, Czechia, France, Germany, Ireland, Italy, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026