Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug InterventionNCT06258980
Use of Recombinant Factor VII as a Prophylactic Therapy for Adolescent Females With Heavy Menstrual Bleeding
An observational study of Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention, run by Minia University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention
- What is being tested?
- Proph7
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 5 Feb 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: adolescent females known Glanzmanns Thrombaesthenia with heavy menstrual bleeding
Who may be able to join
- adolescent females proved to be Glanzmanns Thrombaesthenia heavy menstrual bleeding no improvment by platelet transfusion or antifibrinolytic therapy
Who cannot join
- chronic systemic disease previous allergic reaction to recombinant FVII
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Proph7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proph7Drug
Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females
| Study group | Role | What they receive |
|---|---|---|
| heavily menstruating females with glanzmannns Thrombaesthenia | Not described Receives: Drug: Proph7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
regular accepted menstrual cycles less than 6 days
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start15 Jan 2023
- Primary completion2 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Minia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehan Lotfy Abdel Hakeem, Minia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258980
- Sponsor's protocol ID
- MiniaUH
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor and Consultant of Pediatric Hematology Faculty of Medicine, Minia University, Al Minya, Egypt.
- ClinicalTrials.gov ID
- NCT06258980
- Acronym / sponsor ID
- MiniaUH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Minia University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heavily menstruating females with glanzmannns Thrombaesthenia | – | Drug: Proph7 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- adolescent females known Glanzmanns Thrombaesthenia with heavy menstrual bleeding
Key inclusion criteria (1 listed)
- adolescent females proved to be Glanzmanns Thrombaesthenia heavy menstrual bleeding no improvment by platelet transfusion or antifibrinolytic therapy
Key exclusion criteria (2 listed)
- chronic systemic disease previous allergic reaction to recombinant FVII
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proph7Prophylactic recombinant FVII for heavily menorrhagic adolescent Glanzmanns Thrombaesthenia females | Drug | heavily menstruating females with glanzmannns Thrombaesthenia |
Primary outcome
regular accepted menstrual cycles less than 6 days
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessing the Bleeding Profile and the Quality of Life of the Enrolled Patients Before and 1 Year After Drug Intervention, run by Minia University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regular accepted menstrual cycles less than 6 days (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.