--- title: Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis nct_id: NCT07332091 overall_status: RECRUITING phase: PHASE2 sponsor: CSL Behring study_type: INTERVENTIONAL primary_condition: Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, Romania, Spain, Switzerland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07332091.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07332091" ct_last_update_post_date: 2026-03-27 last_seen_at: "2026-05-12T06:04:34.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis **Official Title:** A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects With HFE-related Hereditary Hemochromatosis (FERROCLEAR Study) **NCT ID:** [NCT07332091](https://clinicaltrials.gov/study/NCT07332091) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 84 - **Lead Sponsor:** CSL Behring - **Conditions:** Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis - **Start Date:** 2026-01-22 - **Completion Date:** 2028-04-06 - **CT.gov Last Update:** 2026-03-27 ## Brief 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 3 and 16 mg/g (53.7 and 286.5 millimol per kilogram \[mmol/kg\]) dry weight (dw) at Screening. * Body mass index between 18.5 and 32 kilograms per meter squared (kg/m\^2). Exclusion Criteria: * Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history. ``` ## Arms - **Vamifeport Low Dose** (EXPERIMENTAL) — Participants will receive a low dose of vamifeport orally, twice daily (BID) up to Day 360. - **Vamifeport High Dose** (EXPERIMENTAL) — Participants will receive a high dose of vamifeport orally, BID up to Day 360. - **Placebo** (PLACEBO_COMPARATOR) — Participants will receive placebo matching vamifeport low and high doses orally, BID up to Day 360. ## Interventions - **Vamifeport** (DRUG) — Vamifeport capsule administered orally. - **Placebo** (DRUG) — Placebo capsule matching IP administered orally. ## Primary Outcomes - **Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC)** _(time frame: At Baseline and Day 360)_ ## Secondary Outcomes - **Number of participants with treatment-emergent adverse events (TEAEs)** _(time frame: Up to Day 390)_ - **Percentage of participants with TEAEs** _(time frame: Up to Day 390)_ - **Number of participants with treatment-emergent serious adverse events (SAEs)** _(time frame: Up to Day 390)_ - **Percentage of participants with treatment-emergent SAEs** _(time frame: Up to Day 390)_ - **Number of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead electrocardiogram (ECG)** _(time frame: From Baseline to Day 390)_ - **Percentage of participants with clinically significant change from baseline in clinical safety laboratory tests and 12-lead ECG** _(time frame: From Baseline to Day 390)_ - **Change from baseline in transferrin saturation (TSAT) (measured at trough)** _(time frame: From Baseline to Day 360)_ - **Number of participants with TSAT less than or equal to (<=) 45% (measured at trough)** _(time frame: From Baseline to Day 360)_ - **Percentage of participants with TSAT <= 45% (measured at trough)** _(time frame: From Baseline to Day 360)_ - **Number of participants with 25% reduction in MRI-based LIC** _(time frame: At Day 180 and 360)_ - **Number of participants with 50% reduction in MRI-based LIC** _(time frame: At Day 180 and Day 360)_ - **Number of participants with TSAT ≤ 45% or MRI-based LIC < 5 milligrams per gram (mg/g)** _(time frame: At Day 360)_ - **Number of participants with TSAT ≤ 45% or MRI-based LIC < 2 mg/g** _(time frame: At Day 360)_ - **Change from baseline in joint pain score in a visual analog scale (VAS)** _(time frame: From Baseline to Day 360)_ - **Change from baseline in modified fatigue impact scale (MFIS) total score** _(time frame: From Baseline to Day 360)_ - **Change from baseline in health-related quality of life: EuroQoL 5-dimension 5-level instrument (EQ-5D-5L)** _(time frame: From Baseline to Days 180, 360, and 390)_ - **Change from baseline in health-related quality of life: VAS (Arthralgia)** _(time frame: From Baseline to Day 180, 360, and 390)_ - **Change from baseline in health-related quality of life: Patient global impression of change in clinical status** _(time frame: From Baseline to Day 180, 360, and 390)_ - **Change from baseline in health-related quality of life: Patient global impression of severity** _(time frame: From Baseline to Day 180, 360, and 390)_ - **Change from baseline in health-related quality of life: MFIS physical, cognitive, and psychosocial subscales** _(time frame: From Baseline to Day 180, 360, and 390)_ - **Vamifeport plasma concentrations after a single dose** _(time frame: At Day 1)_ - **Vamifeport plasma concentrations at steady state** _(time frame: At Days 15, 180, and 360)_ - **Change from baseline in total serum iron (measured at trough)** _(time frame: From Baseline to Day 360)_ - **Change from baseline in serum ferritin (measured at trough)** _(time frame: From Baseline to Day 360)_ - **Frequency of rescue therapy use** _(time frame: Up to Day 390)_ - **Duration of rescue therapy use** _(time frame: Up to Day 390)_ - **Time to first use of rescue therapy** _(time frame: Up to Day 360)_ ## Locations (96) - Banner MD Anderson, Gilbert, Arizona, United States — _NOT_YET_RECRUITING_ - Infinity Clinical Trials, San Diego, California, United States — _NOT_YET_RECRUITING_ - Medical Oncology Associates of San Diego, San Diego, California, United States — _NOT_YET_RECRUITING_ - Green Leaf Clinical Trials, Jacksonville, Florida, United States — _RECRUITING_ - Indiana University Health University Hospital, Indianapolis, Indiana, United States — _NOT_YET_RECRUITING_ - Ochsner Medical Complex - High Grove, Baton Rouge, Louisiana, United States — _NOT_YET_RECRUITING_ - Johns Hopkins University School of Medicine, Baltimore, Maryland, United States — _NOT_YET_RECRUITING_ - American Oncology Partners, PA dba The Center for Cancer and Blood Disorders, Bethesda, Maryland, United States — _NOT_YET_RECRUITING_ - James M. Stockman Cancer Institute, Frederick, Maryland, United States — _NOT_YET_RECRUITING_ - University of Michigan Health System (UMHS), Ann Arbor, Michigan, United States — _NOT_YET_RECRUITING_ - Aspirus St. Luke's Clinic - Duluth - Oncology & Hematology, Duluth, Minnesota, United States — _NOT_YET_RECRUITING_ - Hunterdon Hematology Oncology, LLC, Flemington, New Jersey, United States — _NOT_YET_RECRUITING_ - University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States — _NOT_YET_RECRUITING_ - Duke University Medical Center (Duke South Clinics) -40 Duke Medicine Cir, Durham, North Carolina, United States — _NOT_YET_RECRUITING_ - Hightower Clinical - Oklahoma Cancer Center, Oklahoma City, Oklahoma, United States — _NOT_YET_RECRUITING_ - Intermountain Medical Center, Murray, Utah, United States — _NOT_YET_RECRUITING_ - Washington State Univ Elson S. Floyd College of Medicine, Spokane, Washington, United States — _RECRUITING_ - Royal Brisbane and Women's Hospital, Brisbane, Australia — _NOT_YET_RECRUITING_ - Gallipoli Medical Research, Chandler, Australia — _NOT_YET_RECRUITING_ - Monash Medical Centre, Clayton, Australia — _NOT_YET_RECRUITING_ - Trials West, Perth, Australia — _NOT_YET_RECRUITING_ - Westmead Hospital for Medical Research, Westmead, Australia — _NOT_YET_RECRUITING_ - Medical University of Innsbruck, Innsbruck, Austria — _NOT_YET_RECRUITING_ - Ordensklinikum Linz - Barmherzige Schwestern, Linz, Austria — _NOT_YET_RECRUITING_ - Medical University Vienna, Vienna, Austria — _NOT_YET_RECRUITING_ - Universitair Ziekenhuis Antwerpen (UZA), Edegem, Belgium — _NOT_YET_RECRUITING_ - Ghent University Hospital, Ghent, Belgium — _NOT_YET_RECRUITING_ - UZ Brussel, Jette, Belgium — _NOT_YET_RECRUITING_ - Centre Hospitalier Universitaire de Liège (CHU de Liège), Liège, Belgium — _NOT_YET_RECRUITING_ - CHU UCL Namur - Site Godinne, Yvoir, Belgium — _NOT_YET_RECRUITING_ - Libin Cardiovascular Institute University of Calgary, Calgary, Canada — _NOT_YET_RECRUITING_ - McMaster University-St. Josephs Healthcare Hamilton, Hamilton, Canada — _NOT_YET_RECRUITING_ - University of Manitoba, Winnipeg, Canada — _NOT_YET_RECRUITING_ - Fakultní Nemocnice Brno, Brno, Czechia — _NOT_YET_RECRUITING_ - Fakultni nemocnice Ostrava, Ostrava, Czechia — _NOT_YET_RECRUITING_ - Institut Klinicke a Experimentalni Mediciny, Prague, Czechia — _NOT_YET_RECRUITING_ - Aarhus University Hospital, Aarhus, Denmark — _NOT_YET_RECRUITING_ - Bispebjerg Hospital, Copenhagen, Denmark — _NOT_YET_RECRUITING_ - Copenhagen University Hospital - Hvidovre, Hvidovre, Denmark — _NOT_YET_RECRUITING_ - Aphp Avicenne, Bobigny, France — _NOT_YET_RECRUITING_ - Chu Dupuytren, Limoges, France — _NOT_YET_RECRUITING_ - CRMR Maladies du Globule Rouge, Hôpital de la Timone, Marseille, France — _NOT_YET_RECRUITING_ - CHU de Montpellier- Hôpital Saint Eloi, Montpellier, France — _NOT_YET_RECRUITING_ - GHRMSA, Mulhouse, France — _NOT_YET_RECRUITING_ - CHU de Bordeaux - Hôpital Haut Leveque, Pessac, France — _NOT_YET_RECRUITING_ - Centre Hospitalier Lyon Sud/Hospices Civils de Lyon, Pierre-Bénite, France — _NOT_YET_RECRUITING_ - Chu Rennes, Rennes, France — _NOT_YET_RECRUITING_ - Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France — _NOT_YET_RECRUITING_ - CHU Toulouse, Toulouse, France — _NOT_YET_RECRUITING_ - Hôpital Paul Brousse, Villejuif, France — _NOT_YET_RECRUITING_ - Universitätsklinikum Freiburg, Freiburg im Breisgau, Germany — _NOT_YET_RECRUITING_ - University Hospital Heidelberg, Heidelberg, Germany — _NOT_YET_RECRUITING_ - EUGASTRO GmbH, Leipzig, Germany — _NOT_YET_RECRUITING_ - MVZ für Innere Medizin Weinheim, Weinheim, Germany — _NOT_YET_RECRUITING_ - Cork University Hospital, Cork, Ireland — _NOT_YET_RECRUITING_ - Beaumont Hospital, Dublin, Ireland — _NOT_YET_RECRUITING_ - Connolly Hospital Blanchardstown, Dublin, Ireland — _NOT_YET_RECRUITING_ - ASL Brindisi - Presidio Ospedaliero Di Summa - Perrino, Brindisi, Italy — _NOT_YET_RECRUITING_ - Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan, Italy — _NOT_YET_RECRUITING_ - University Hospital of Modena, Modena, Italy — _NOT_YET_RECRUITING_ - Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy — _NOT_YET_RECRUITING_ - AORN Cardarelli, Naples, Italy — _NOT_YET_RECRUITING_ - University of Verona - Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy — _NOT_YET_RECRUITING_ - Maastricht UMC, Maastricht, Netherlands — _NOT_YET_RECRUITING_ - Radboud UMC, Nijmegen, Netherlands — _NOT_YET_RECRUITING_ - Auckland City Hospital, Auckland, New Zealand — _NOT_YET_RECRUITING_ - Aotearoa Clinical Trials Trust- Middlemore Hospital, Auckland, New Zealand — _NOT_YET_RECRUITING_ - Instytut Hematologii i Transfuzjologii, Warsaw, Poland — _NOT_YET_RECRUITING_ - Specjalistyczny Szpital im. Alfreda Sokolowskiego, Wałbrzych, Poland — _NOT_YET_RECRUITING_ - Wojewodzki Szpital im. J Gromkowskiego we Wroclawiu, Wroclaw, Poland — _NOT_YET_RECRUITING_ - Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu-Balotesti, Baloteşti, Romania — _NOT_YET_RECRUITING_ - Bistrița County Emergency Clinical Hospital, Bistriţa, Romania — _NOT_YET_RECRUITING_ - Coltea Clinical Hospital, Bucharest, Romania — _NOT_YET_RECRUITING_ - L'Institute Oncologique Prof. Dr. Ion Chiricuta (IOCN), Cluj-Napoca, Romania — _NOT_YET_RECRUITING_ - Prof. Dr.Octavian Fodor Regional Institute of Gastroenterology-Hepatology, Cluj-Napoca, Romania — _NOT_YET_RECRUITING_ - Hospital Universitari Germans Trias i Pujol, Badalona, Spain — _NOT_YET_RECRUITING_ - Hospital Clinic Barcelona, Barcelona, Spain — _NOT_YET_RECRUITING_ - HUGC Doctor Negrin, LAS Palmas de GC, Spain — _NOT_YET_RECRUITING_ - Hospital Universitario La Paz, Madrid, Spain — _NOT_YET_RECRUITING_ - Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Spain — _NOT_YET_RECRUITING_ - Althaia Foundation. Hospital Sant Joan de Deu de Manresa, Manresa, Spain — _NOT_YET_RECRUITING_ - Hospital Universitario Virgen del Rocío, Seville, Spain — _NOT_YET_RECRUITING_ - University Hospital Inselspital Bern, Bern, Switzerland — _NOT_YET_RECRUITING_ - Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland — _NOT_YET_RECRUITING_ - Epatocentro Ticino, Lugano, Switzerland — _NOT_YET_RECRUITING_ - Royal Victoria Hospital, Belfast, United Kingdom — _NOT_YET_RECRUITING_ - University Hospitals Bristol and Weston NHS trust, Bristol Haematology and Oncology Centre, Bristol, United Kingdom — _NOT_YET_RECRUITING_ - Royal Liverpool University Hospital, Liverpool, United Kingdom — _NOT_YET_RECRUITING_ - King's College Hospital, London, United Kingdom — _NOT_YET_RECRUITING_ - St Thomas Hospital, London, United Kingdom — _NOT_YET_RECRUITING_ - Norfolk and Norwich University Hospital, Norwich, United Kingdom — _NOT_YET_RECRUITING_ - Nottingham University Hospitals City Campus, Nottingham, United Kingdom — _NOT_YET_RECRUITING_ - John Radcliffe Hospital - Oxford University Hospitals NHS, Oxford, United Kingdom — _NOT_YET_RECRUITING_ - Derriford Hospital, Plymouth, United Kingdom — _NOT_YET_RECRUITING_ - University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom — _NOT_YET_RECRUITING_ - South Warwickshire University Foundation Trust, Warwick, United Kingdom — _NOT_YET_RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.banner md anderson|gilbert|arizona|united states` — added _(2026-05-12)_ - `locations.ghrmsa|mulhouse||france` — added _(2026-05-12)_ - `locations.infinity clinical trials|san diego|california|united states` — added _(2026-05-12)_ - `locations.medical oncology associates of san diego|san diego|california|united states` — added _(2026-05-12)_ - `locations.green leaf clinical trials|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.indiana university health university hospital|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.ochsner medical complex - high grove|baton rouge|louisiana|united states` — added _(2026-05-12)_ - `locations.johns hopkins university school of medicine|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.american oncology partners, pa dba the center for cancer and blood disorders|bethesda|maryland|united states` — added _(2026-05-12)_ - `locations.james m. stockman cancer institute|frederick|maryland|united states` — added _(2026-05-12)_ - `locations.university of michigan health system (umhs)|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.aspirus st. luke's clinic - duluth - oncology & hematology|duluth|minnesota|united states` — added _(2026-05-12)_ - `locations.hunterdon hematology oncology, llc|flemington|new jersey|united states` — added _(2026-05-12)_ - `locations.university of north carolina at chapel hill|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.duke university medical center (duke south clinics) -40 duke medicine cir|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.hightower clinical - oklahoma cancer center|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.intermountain medical center|murray|utah|united states` — added _(2026-05-12)_ - `locations.washington state univ elson s. floyd college of medicine|spokane|washington|united states` — added _(2026-05-12)_ - `locations.royal brisbane and women's hospital|brisbane||australia` — added _(2026-05-12)_ - `locations.gallipoli medical research|chandler||australia` — added _(2026-05-12)_ - `locations.monash medical centre|clayton||australia` — added _(2026-05-12)_ - `locations.trials west|perth||australia` — added _(2026-05-12)_ - `locations.beaumont hospital|dublin||ireland` — added _(2026-05-12)_ - `locations.westmead hospital for medical research|westmead||australia` — added _(2026-05-12)_ - `locations.medical university of innsbruck|innsbruck||austria` — added _(2026-05-12)_ - `locations.ordensklinikum linz - barmherzige schwestern|linz||austria` — added _(2026-05-12)_ - `locations.medical university vienna|vienna||austria` — added _(2026-05-12)_ - `locations.universitair ziekenhuis antwerpen (uza)|edegem||belgium` — added _(2026-05-12)_ - `locations.ghent university hospital|ghent||belgium` — added _(2026-05-12)_ - `locations.uz brussel|jette||belgium` — added _(2026-05-12)_ - `locations.centre hospitalier universitaire de liège (chu de liège)|liège||belgium` — added _(2026-05-12)_ - `locations.chu ucl namur - site godinne|yvoir||belgium` — added _(2026-05-12)_ - `locations.libin cardiovascular institute university of calgary|calgary||canada` — added _(2026-05-12)_ - `locations.mcmaster university-st. josephs healthcare hamilton|hamilton||canada` — added _(2026-05-12)_ - `locations.university of manitoba|winnipeg||canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07332091.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07332091* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*