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

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

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.

Study Overview

• Status: Completed
• Conditions: Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention
• Intervention / Treatment: Drug: Proph7

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Egypt
  • Al Minyā, Egypt, 61111
    • Gehan Lotfy Abdel Hakeem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

adolescent females known Glanzmanns Thrombaesthenia with heavy menstrual bleeding

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
heavily menstruating females with glanzmannns Thrombaesthenia	Drug: Proph7; Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
regular accepted menstrual cycles less than 6 days	1 year

Collaborators and Investigators

• Sponsor: Minia University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: MiniaUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes