Caring for patients with non-transfusion dependent beta-thalassemia?
Consider the FERVENT-1 clinical study
Given the limited treatment options for patients with iron overload due to non-transfusion dependent beta-thalassemia (NTDT), the FERVENT-1 clinical research study is currently investigating new potential treatments. Consider the FERVENT-1 clinical research study as an opportunity for your patients with iron overload due to NTDT to access emerging treatments.
FERVENT-1 is a phase 2 clinical study for adults with iron overload due to NTDT. This study is evaluating the effect of the investigational treatment on liver iron concentration and the safety and tolerability of at least 2 different doses of investigational treatment compared to placebo.
FERVENT-1 will last about 78 weeks (about 1.5 years). Over the course of the study, the study treatment will be administered as a subcutaneous injection. It is a monoclonal antibody that attaches to transmembrane serine protease 6 (TMPRSS6) and blocks its function. Since TMPRSS6 normally increases iron levels in the blood, blocking this protein with the study treatment may reduce excess iron levels.
Patients are expected to participate in this study for approximately 1.5 years. During the study, participants will have up to approximately 22 study visits. Qualified participants may be reimbursed for travel to and from the site for study visits if allowed and approved by local regulatory/ethics committee.
How can you help?
FERVENT-1 is planning to enroll approximately 95 people with NDTD in 9 countries. The success of the FERVENT-1 clinical study depends on physicians to refer potential study participants. Your patients may be eligible if they are:
- 18 to 60 years of age
- Clinical diagnosis of NTDT
- Iron overload, defined as liver iron concentration ≥5 mg Fe/g dry weight as measured by R2* MRI at screening
- Serum ferritin ≥300 ng/mL
Please note: Other protocol-defined inclusion/exclusion criteria apply.
The study team will check your patient’s full medical history to see if they meet all inclusion criteria and none of the exclusion criteria. Diversity in clinical studies is critical to developing better treatments – help ensure that your patients are represented.
If you have potentially eligible and interested patients, empower them with options and discuss the FERVENT-1 clinical study. You may also contact the nearest study site to refer them.
Find a study site near you!
Your patient’s health and safety are our top priorities. We hope you value the impact of this research and will consider referring potential candidates. With your support, we hope to help patients with non-transfusion dependent beta-thalassemia.