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

NCT06258980 | Completed DMC FDA Drug

• 1 other identifier: MiniaUH
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• regular accepted menstrual cycles less than 6 days

  1 year

Study Arms (1)

heavily menstruating females with glanzmannns Thrombaesthenia

Drug: Proph7

Interventions

Proph7 DRUG

Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females

heavily menstruating females with glanzmannns Thrombaesthenia

Eligibility Criteria

• Age: 12 Years - 18 Years
• Gender Eligibility Details: heavy menstrual bleeders
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

adolescent females known Glanzmanns Thrombaesthenia with heavy menstrual bleeding

You may qualify if:

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

You may not qualify if:

• chronic systemic disease previous allergic reaction to recombinant FVII

Sponsors & Collaborators

• Minia University Hospital: lead

Study Sites (1)

Gehan Lotfy Abdel Hakeem

Al Minyā, 61111, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatric hematology, Minia University

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: January 15, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 5, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)