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An 18-month low-interventional prospective, multicentre study to assess joint outcomes in patients with haemophilia A or B on prophylaxis with efmoroctocog alfa or eftrenonacog alfa

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502921-16-00
Acronym
Sobi.HAEM89-007
Enrollment
247
Registered
2023-06-13
Start date
2023-07-21
Completion date
2023-12-01
Last updated
2023-10-16

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

Conditions

Hemophilia A and B

Brief summary

Change from baseline in total HEAD-US score up to month 18 (end of study - EOS)

Detailed description

Change from baseline in HEAD-US score for hypertrophic synovium at 6, 12 and 18 months, Change from baseline in HEAD-US score for cartilage at 6, 12 and 18 months, Change from baseline in HEAD-US score for bone at 6, 12 and 18 months, Change from baseline in total HJHS at month 18 (EOS), Number and location of target joints at baseline, 6, 12 and 18 months, Total Annualized bleeding rate (ABR), joint ABR, target joint ABR, traumatic/spontaneous ABR, Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/activity scores at baseline and 18 months, PROMIS pain intensity and interference scores at baseline and 18 months, IPAQ-SF scores at baseline and 18 months

Interventions

DRUGELOCTA 750 IU Powder and solvent for solution for injection
DRUGELOCTA 1500 IU Powder and solvent for solution for injection
DRUGELOCTA 500 IU Powder and solvent for solution for injection
DRUGELOCTA 3000 IU powder and solvent for solution for injection
DRUGALPROLIX 250 IU powder and solvent for solution for injection
DRUGELOCTA 2000 IU Powder and solvent for solution for injection
DRUGELOCTA 4000 IU powder and solvent for solution for injection
DRUGALPROLIX 500 IU powder and solvent for solution for injection
DRUGALPROLIX 1000 IU powder and solvent for solution for injection
DRUGALPROLIX 2000 IU powder and solvent for solution for injection
DRUGALPROLIX 3000 IU powder and solvent for solution for injection
DRUGELOCTA 1000 IU Powder and solvent for solution for injection
DRUGELOCTA 250 IU Powder and solvent for solution for injection

Sponsors

Swedish Orphan Biovitrum AB (publ)
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in total HEAD-US score up to month 18 (end of study - EOS)—

Secondary

MeasureTime frame
Change from baseline in HEAD-US score for hypertrophic synovium at 6, 12 and 18 months, Change from baseline in HEAD-US score for cartilage at 6, 12 and 18 months, Change from baseline in HEAD-US score for bone at 6, 12 and 18 months, Change from baseline in total HJHS at month 18 (EOS), Number and location of target joints at baseline, 6, 12 and 18 months, Total Annualized bleeding rate (ABR), joint ABR, target joint ABR, traumatic/spontaneous ABR, Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/activity scores at baseline and 18 months, PROMIS pain intensity and interference scores at baseline and 18 months, IPAQ-SF scores at baseline and 18 months—

Countries

Bulgaria, Croatia, Czechia, France, Hungary, Ireland, Italy, Romania, Slovenia, Spain

Outcome results

None listed

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