A study comparing Emicizumab and Extended Half-Life Factor VIII for reducing bleeding episodes in Hemophilia A patients without inhibitors.

A pilot Randomised Control Trial comparing the efficacy and safety of Standard Dose and Low dose Emicizumab prophylaxis with Extended Half Life Factor VIII concentrate in children with severe Hemophilia A without Inhibitors - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/096854

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: D66- Hereditary factor VIII deficiency

Interventions

Intervention1: Standard Dose Emicizumab prophylaxis: Patients will receive prophylaxis with emicizumab, administered subcutaneously at standard dose regimen (loading dose 3 mg/kg weekly for 4 weeks fo

Eligibility

Inclusion criteria

Inclusion criteria: Severe Hemophilia A without Inhibitors and has not been on prophylactic therapy with either Extended Half Life Factor VIII or Emicizumab

Exclusion criteria

Exclusion criteria: Presence of FVIII inhibitors Known case of coagulopathies and bleeding disorders other than Hemophilia A

Design outcomes

Primary

Measure	Time frame
To assess and compare Annualized Bleeding Rate ( spontaneous, Traumatic, Joint bleeds) between various treatment groupsTimepoint: At baseline and end of 6 months of prophylaxis	—

Secondary

Measure	Time frame
Hemophilia Joint Health Score (HJHS)Timepoint: At baseline and and of 6 months;Haemo-QoL scoreTimepoint: At baseline and end of 6 months;Adverse events monitoringTimepoint: Any time during the study	—

Countries

India

Contacts

Public ContactAswathy V Nair

Shyam Shah Medical College and Associated SGMH, GMH

drgtripathi@gmail.com9630132488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026