Clinical Trials in Poland / NCT07332091
Active, not recruiting
Phase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
NCT07332091 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Investigational drug(s) / intervention(s)
VamifeportPlacebo
Vamifeport: Vamifeport capsule administered orally.
Placebo: Placebo capsule matching IP administered orally.
Study summary
This is a phase 2, multicenter, randomized, placebo-controlled, double-blind, parallel-group, proof-of-concept study to assess vamifeport in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH). The primary objective of the study is to assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with HFE-HH.
Eligibility
Inclusion Criteria:
* Adult (≥ 18 years) and has provided written informed consent.
* Confirmed diagnosis of HFE-HH in medical history.
* Evidence of iron overload as shown by:
* TSAT \> 45% (confirmed at 2 visits, at least 14 days apart) at Screening; and
* Serum ferritin ≥ 200 nanogram per milliliter (ng/mL) and \< 5000 ng/mL (confirmed at 2 visits, at least 14 days apart) at Screening; and
* MRI-based LIC between 2.4 and 16 mg/g (43.0 and 286.5 mmol/kg) dry weight (dw) at Screening.
* Body mass index between 18.5 and 34.9 kilograms per meter squared (kg/m\^2).
Exclusion Criteria:
* Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.
Primary outcome measure(s)
- Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) — At Baseline and Day 360
Trial sites (100)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | |
| Infinity Clinical Trials | San Diego | California | |
| Medical Oncology Associates of San Diego | San Diego | California | |
| Green Leaf Clinical Trials | Jacksonville | Florida | |
| Global Medical Research Management LLC | Miami | Florida | |
| Indiana University Health University Hospital | Indianapolis | Indiana | |
| Ochsner Medical Complex - High Grove | Baton Rouge | Louisiana | |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | |
| American Oncology Partners, PA dba The Center for Cancer and Blood Disorders | Bethesda | Maryland | |
| James M. Stockman Cancer Institute | Frederick | Maryland | |
| University of Michigan Health System (UMHS) | Ann Arbor | Michigan | |
| Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology | Duluth | Minnesota | |
| Hunterdon Hematology Oncology, LLC | Flemington | New Jersey | |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir | Durham | North Carolina | |
| Hightower Clinical - Oklahoma Cancer Center | Oklahoma City | Oklahoma | |
| Cancer Care Associates of York | York | Pennsylvania | |
| Intermountain Medical Center | Murray | Utah | |
| Velocity Clinical Research - Seattle | Seattle | Washington | |
| Washington State Univ Elson S. Floyd College of Medicine | Spokane | Washington | |
| Gallipoli Medical Research | Chandler | Queensland | |
| Royal Brisbane and Women's Hospital | Brisbane | Australia | |
| Monash Medical Centre | Clayton | Australia | |
| Trials West | Perth | Australia | |
| Westmead Hospital for Medical Research | Westmead | Australia | |
| Medical University of Innsbruck | Innsbruck | Austria | |
| Ordensklinikum Linz - Barmherzige Schwestern | Linz | Austria | |
| Medical University Vienna | Vienna | Austria | |
| Ghent University Hospital | Ghent | West Vlaanderen | |
| Universitair Ziekenhuis Antwerpen (UZA) | Edegem | Belgium | |
| UZ Brussel | Jette | Belgium | |
| Centre Hospitalier Universitaire de Liège (CHU de Liège) | Liège | Belgium | |
| CHU UCL Namur - Site Godinne | Yvoir | Belgium | |
| Libin Cardiovascular Institute University of Calgary | Calgary | Canada | |
| McMaster University-St. Josephs Healthcare Hamilton | Hamilton | Canada | |
| University of Manitoba | Winnipeg | Canada | |
| Fakultní Nemocnice Brno | Brno | Czechia | |
| Fakultni nemocnice Ostrava | Ostrava | Czechia | |
| Institut Klinicke a Experimentalni Mediciny | Prague | Czechia | |
| Aarhus University Hospital | Aarhus | Denmark |
+ 60 more sites — see the full list on the official registry below.
More CSL Behring trials in Poland
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07332091 on ClinicalTrials.gov ↗ ← All trials in Poland