Study Stopped
FORMA-07 was initiated as a requirement imposed by the U.S. FDA as part of Octapharma's regulatory obligations. After approving Fibryga for treatment of acquired fibrinogen deficiency in 2024, FDA has agreed that the study may now be discontinued.
Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Post-marketing Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
1 other identifier
observational
7
2 countries
4
Brief Summary
Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 4, 2019
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2025
CompletedJune 24, 2025
June 1, 2025
4.3 years
December 19, 2018
June 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of thromboembolic adverse drug reactions (ADRs)
The incidence of thromboembolic ADRs in patients receiving Fibryga for on-demand treatment of bleeding, including major bleeding, will be documented
Day 0-28
Secondary Outcomes (4)
Hemostatic efficacy of Fibryga for all bleeding events (BEs) collected in the study will be assessed by the investigator using a 4-point hemostatic efficacy scale
Within 2-24 hours following treatment of BEs
Dosage of Fibryga
Within 2-24 hours following treatment of BEs
Duration of BEs
Within 2-24 hours following treatment of BEs
Incidence of treatment-emergent adverse events (safety)
Day 0-28
Study Arms (1)
Fibryga
Fibryga (human plasma-derived fibrinogen concentrate)
Interventions
Eligibility Criteria
Approximately 25 patients with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia are planned to be documented in this study
You may qualify if:
- Patients of any age with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia expected to require on-demand in-hospital treatment for BEs with Fibryga
You may not qualify if:
- Bleeding disorder other than congenital fibrinogen deficiency
- Patients with acquired fibrinogen deficiency or dysfibrinogenemia
- Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery, if available, of \<0.5 (mg/dL)/(mg/kg); there is currently no standard test for inhibitors
- Participation in an interventional clinical study at the time of or within 4 weeks prior to enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Octapharmalead
Study Sites (4)
Fakultní nemocnice Ostrava
Ostrava, Czechia
Gerinnungszentrum rhein-ruhr
Duisburg, Germany
Medizinische Klinik 2 / Institut für Transfusionsmedizin Universitätsklinikum
Frankfurt, Germany
Gerinnungszentrum Hochtaunus
Hamburg, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2018
First Posted
January 4, 2019
Study Start
January 28, 2021
Primary Completion
May 14, 2025
Study Completion
May 14, 2025
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share