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Clinical Trials/CTRI/2024/01/061593
CTRI/2024/01/061593
Recruiting
Phase 4

Evaluation of efficacy and safety of low dose versus standard dose Emicizumab for the treatment of Hemophilia A – A randomized controlled trial - Nil

Department of Health Research, India0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: D66- Hereditary factor VIII deficiency

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: D66- Hereditary factor VIII deficiency
Sponsor
Department of Health Research, India
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Health Research, India

Eligibility Criteria

Inclusion Criteria

  • •All persons with haemophilia A(PWH)with FVIII levels less than 2 percentage as seen in case notes with age ranging from 2 to 17 years
  • •PWH with and without the presence of FVIII inhibitors
  • •PWH with inhibitors not planning for immune tolerance induction or where immune
  • •tolerance induction has failed
  • •PWH with hepatitis and HIV
  • •Parents or patients willing to signed and give written informed consent or assent as
  • •appropriate
  • •Children and caregivers willing to comply with scheduled visits, treatment plans, laboratory
  • •tests, and other study procedures, including the questionnaires.
  • •Written or verbal assent as appropriate from children participating in the study

Exclusion Criteria

  • •Patients who will find it difficult to follow the protocol based on PI judgement
  • •Patients posted for elective surgery
  • •Inherited or acquired bleeding disorder other than hemophilia A
  • •Ongoing Immune tolerance Induction therapy (prophylaxis regimens with FVIII and or
  • •bypassing agents must be discontinued prior to enrollment)

Outcomes

Primary Outcomes

Not specified

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