Phase
Condition
Thalassemia
Treatment
Placebo
REGN7999
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Clinical diagnosis of NTDT as described in the protocol
IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2* MRI at screening
Serum ferritin ≥ 300 ng/mL as described in the protocol
Exclusion
Key Exclusion Criteria:
Hemoglobin ≤ 8 g/dL
Any RBC transfusion within 12 weeks of visit 3
For Part A only: Any ICT use in approximately 12 weeks prior to screening asdescribed in the protocol
For Part B only: If on ICT, any change in Iron chelation therapy (ICT) dose inapproximately 12 weeks prior to screening as described in the protocol
Any use of luspatercept or mitapivat in 6 months prior to screening as described inthe protocol
Absolute contraindication to MRI
Diagnosis of cirrhosis of the liver
Diagnosis of Chronic kidney disease (CKD) stage 4 or higher
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study Design
Connect with a study center
K Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159
GeorgiaActive - Recruiting
Medinvest Institute of Hematology and Transfusiology Limited
Tbilisi, 0160
GeorgiaActive - Recruiting
All India Institute of Medical Sciences, New Delhi
New Delhi, Delhi 110029
IndiaActive - Recruiting
Hemato-Oncology Clinic (HOC)
Ahmedabad, Gujarat 380009
IndiaActive - Recruiting
Hemato-Oncology Clinic Ahmedabad PVT. LTD.
Ahmedabad, Gujarat 380009
IndiaActive - Recruiting
Nirmal Hospital Pvt. Ltd - Surat
Surat, Gujarat 395002
IndiaActive - Recruiting
Amrita Institute of Medical Sciences and Research Centre (AIMS)
Kochi, Kerala 682041
IndiaActive - Recruiting
K J Somaiya Super Specialty Hospital & Research Centre
Mumbai, Maharashtra 400022
IndiaActive - Recruiting
JK Lon Hospital
Jaipur, Rajasthan 302004
IndiaActive - Recruiting
Indraprastha Apollo Hospitals
Delhi, 110048
IndiaActive - Recruiting
Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM)
Cheras, Kuala Lumpur 56000
MalaysiaActive - Recruiting
Hospital Queen Elizabeth
Kota Kinabalu, Sabah 88586
MalaysiaActive - Recruiting
Sarawak General Hospital
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Hospital Ampang
Ampang, Selangor 68000
MalaysiaActive - Recruiting
Srinagarind Hospital
Maung, Khon Kaen 40000
ThailandActive - Recruiting
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Songkhla 90110
ThailandActive - Recruiting
Chulalongkorn University
Bangkok, 10330
ThailandActive - Recruiting
Chiang Mai University
Chiang Mai, 50200
ThailandActive - Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
United KingdomActive - Recruiting
University College London Hospitals NHS Trust
London, NW1 2PG
United KingdomActive - Recruiting
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