Quality of Life in Patients With Congenital Afibrinogenemia (QualyAFIB)
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ClinicalTrials.gov Identifier: NCT03484065 |
Recruitment Status :
Completed
First Posted : March 30, 2018
Last Update Posted : November 12, 2020
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Condition or disease | Intervention/treatment |
---|---|
Afibrinogenemia, Congenital | Other: Questionnaire quality of life |
Study Type : | Observational |
Actual Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Quality of Life in Patients With Congenital Afibrinogenemia |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | July 2019 |
Actual Study Completion Date : | June 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Afibrinogenemia |
Other: Questionnaire quality of life |
- The influence of the afibrinogenemia on the patients' quality of life assessed by the Haemo-QoL SF questionnaire (for children) and the Haem-A-QoL questionnaire (for adult) [ Time Frame: At inclusion ]
The quality of life questionnaire includes item assessing:
- Physical health
- Feeling
- View
- Family
- Friends
- Others
- Sport and school
- Treatment
- Perceived support
- Dealing
- Future
- Relationship
- Impact of the afibrinogenemic patient's clinical phenotype on the patients' quality of life [ Time Frame: At Inclusion ]
The clinical phenotype will be assessed by a general questionnaire including data on:
- Bleeding events
- Bleeding events treatment
- Thrombotic events
- Thrombotic events treatment
- Fibrinogen replacement (type of product and modality of replacement)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484065

Principal Investigator: | Alessandro Casini, MD | University Hospitals of Geneva |
Responsible Party: | Casini Alessandro, MD, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT03484065 |
Other Study ID Numbers: |
2016-00447 |
First Posted: | March 30, 2018 Key Record Dates |
Last Update Posted: | November 12, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Congenital fibrinogen disorders |
Afibrinogenemia Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |