Quality of Life in Patients With Congenital Afibrinogenemia

NCT ID: NCT03484065

Last Updated: 2020-11-12

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

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-06-30

Brief Summary

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

The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

Detailed Description

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

In this observational study, children and adults suffering from congenital afibrinogenemia confirmed by biology will be enrolled. All patients will receive a questionnaire on quality of life in their own language during a routine visit and filled out by the patient at home. A general questionnaire will be filled out by the patient's physician.

Conditions

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

Afibrinogenemia, Congenital

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Congenital fibrinogen disorders

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

CROSS_SECTIONAL

Study Groups

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

Afibrinogenemia

Questionnaire quality of life

Intervention Type OTHER

Interventions

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

Questionnaire quality of life

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype

Exclusion Criteria

* Lack of participant's consent
* Patient unable to understand the questionnaire
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Casini Alessandro

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alessandro Casini, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Geneva

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital of Orange Count

Orange, California, United States

Site Status

Cohen Children's Medical Center

New Hyde Park, New York, United States

Site Status

Béni Messous

Algiers, , Algeria

Site Status

University of Calgary

Calgary, , Canada

Site Status

Cairo University Pediatric Hospital

Cairo, , Egypt

Site Status

Chru Lille

Lille, , France

Site Status

Universitats Kilinikum Frankfurt

Frankfurt, , Germany

Site Status

Dr von Haumer Children's Hospital

Munich, , Germany

Site Status

St John Medical College Hospital

Bangalore, , India

Site Status

All India Institute of Medical Sciences

New Delhi, , India

Site Status

Sapienza Università di Roma

Roma, , Italy

Site Status

University School of Medicine

Hamamatsu, , Japan

Site Status

Kuwait University

Kuwait City, , Kuwait

Site Status

Hotel Dieu-de-France

Beirut, , Lebanon

Site Status

St George Hospital

Beirut, , Lebanon

Site Status

Hopital d'Enfants de Rabat

Rabat, , Morocco

Site Status

Radboud University Medical Centre

Nijmegen, , Netherlands

Site Status

National Institute Of Blood Disease and Bone Marrow Transplantation

Karachi, , Pakistan

Site Status

Institute of Hematology and Transfusion Medicine

Warsaw, , Poland

Site Status

University Clinical Center

Belgrade, , Serbia

Site Status

National Centre of Hemostasis and Thrombosis

Martin, , Slovakia

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Inselspital

Bern, , Switzerland

Site Status

University Hospitals of Geneva

Geneva, , Switzerland

Site Status

Hopital d'Enfants Bechir Hamza

Tunis, , Tunisia

Site Status

Uludag University

Bursa, , Turkey (Türkiye)

Site Status

Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Algeria Canada Egypt France Germany India Italy Japan Kuwait Lebanon Morocco Netherlands Pakistan Poland Serbia Slovakia Spain Switzerland Tunisia Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Casini A, von Mackensen S, Santoro C, Djambas Khayat C, Belhani M, Ross C, Dorgalaleh A, Naz A, Unal E, Abdelwahab M, Lozeron ED, Trillot N, Susen S, Peyvandi F, de Moerloose P; QualyAfib Study Group. Clinical phenotype, fibrinogen supplementation, and health-related quality of life in patients with afibrinogenemia. Blood. 2021 Jun 3;137(22):3127-3136. doi: 10.1182/blood.2020009472.

Reference Type DERIVED
PMID: 33512441 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-00447

Identifier Type: -

Identifier Source: org_study_id