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OpenTrials
Completed

NCT Number: NCT06258980

Use of Recombinant Factor VII as a Prophylactic Therapy for Adolescent Females With Heavy Menstrual Bleeding

the study is conducted on adolescent females proved to be Glanzmanns Thrombaesthenia with heavy menstrual bleeding by the use of 3 doses of recombinant factor VII in the first day of their cycles. bleeding profile and quality of life were assessed before and 1year after this regular recombinant factor VII administration.

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Key information

Conditions

Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention

Age range

12 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Gehan Lotfy Abdel Hakeem

Al Minyā, 61111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adolescent females proved to be Glanzmanns Thrombaesthenia heavy menstrual bleeding no improvment by platelet transfusion or antifibrinolytic therapy

Exclusion criteria

chronic systemic disease previous allergic reaction to recombinant FVII

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Treatment and study plan

Proph7

Drug

Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females

Primary outcomes

  1. regular accepted menstrual cycles less than 6 days

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Minia University Hospital

Other

Registry information

Official study title

Professor and Consultant of Pediatric Hematology Faculty of Medicine, Minia University, Al Minya, Egypt.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.