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A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

NCT06752850 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-04-30

No results posted yet for this study

Summary

The rationale for conducting this open-label phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.

Conditions

  • Haemophilia A (Moderate or Severe)
  • Hemophilia, Classic
  • Haemophilia
  • Hemophilia
  • Classic Hemophilia
  • Synovial Hypertrophy

Interventions

DRUG

Efanesoctocog alfa

50 IU/kg once weekly, Intravenous injection

Sponsors & Collaborators

  • PSI CRO

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Study Physician · Sobi AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-11-17
Completion
2026-12-28
FDA Drug
Yes

Countries

  • Italy
  • Norway
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06752850 on ClinicalTrials.gov