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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-15

Study Completion Date

2024-02-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Low VW Activity in Adolescent HMB

NCT02933411

Von Willebrand Factor Deficiency

ACTIVE_NOT_RECRUITING

Recombinant Factor VII for Intractable Postpartum Haemorrhage

NCT05298826

Post Partum Hemorrhage

COMPLETED

Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

NCT01234545

Congenital Bleeding Disorder Haemophilia A Haemophilia B

COMPLETED

Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

NCT00323570

Acquired Bleeding Disorder Trauma

WITHDRAWN PHASE3

Study of the Pharmacokinetics and Safety of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) in Patients With Congenital Factor VII Deficiency

NCT02470871

Congenital Coagulation Factor VII Deficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

heavily menstruating females with glanzmannns Thrombaesthenia

Proph7

Intervention Type DRUG

Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Proph7

Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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