ArticleRevista brasileira de hematologia e hemoterapia
A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia.
Article in Revista brasileira de hematologia e hemoterapia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.
- Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022Pooled it
- Pooled it
- Interventions for preventing silent cerebral infarcts in people with sickle cell disease.The Cochrane database of systematic reviews · 2020Pooled it
- Artificial Oxygen Carriers: Lessons From Hemoglobin-Based Oxygen Carrier Clinical Trials and Current Development Efforts.Shock (Augusta, Ga.) · 2026Review
- Transferrin Purification, Biophysical Characterization, and Lung Biodistribution in Sickle Cell Disease Mice.Biotechnology and bioengineering · 2025Article
- Burden of hemoglobinopathies and hemolytic anemias in the World Health Organization African region, 2000-2021: Findings from the Global Burden of Disease 2021 study.PLOS global public health · 2025Article
- Hydrodynamic and thermodynamic analysis of PEGylated human serum albumin.Biophysical journal · 2024Article
- HEMERA 1 CarboxyHEMoglobin oxygEn delivery for Revascularization in Acute Stroke: A Prospective, Randomized Phase 1 Clinical Trial.Stroke (Hoboken, N.J.) · 2024Article
- Neurointerventional infusion of hemoglobin oxygen carrier prevents brain damage from acute cerebral ischemia in rats.Frontiers in surgery · 2023Article
- Recruitment of monocytes primed to express heme oxygenase-1 ameliorates pathological lung inflammation in cystic fibrosis.Experimental & molecular medicine · 2022Article
- Targeting the Heme Oxygenase 1/Carbon Monoxide Pathway to Resolve Lung Hyper-Inflammation and Restore a Regulated Immune Response in Cystic Fibrosis.Frontiers in pharmacology · 2020Review
- Drug Therapies for the Management of Sickle Cell Disease.F1000Research · 2020Review
- Emerging disease-modifying therapies for sickle cell disease.Haematologica · 2019Review
- Therapeutic strategies for sickle cell disease: towards a multi-agent approach.Nature reviews. Drug discovery · 2019Review
- New insights into the pathophysiology and development of novel therapies for sickle cell disease.Hematology. American Society of Hematology. Education Program · 2018Review
- Sickle Cell Anemia and Its Phenotypes.Annual review of genomics and human genetics · 2018Review
- Advances in new drug therapies for the management of sickle cell disease.Expert opinion on orphan drugs · 2018Article
- Inflammation in sickle cell disease.Clinical hemorheology and microcirculation · 2018Article
- SANGUINATE™ (PEGylated Carboxyhemoglobin Bovine) Improves Cerebral Blood Flow to Vulnerable Brain Regions at Risk of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage.Neurocritical care · 2017Article
- The role of carbon monoxide and heme oxygenase in the prevention of sickle cell disease vaso-occlusive crises.American journal of hematology · 2017Review
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickle cell anemia and comorbidities.
methodsAn open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. Another 12 subjects received either a high dose (320mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. The primary endpoint was the safety of SANGUINATE versus hydroxyurea in sickle cell anemia patients. Secondary endpoints included determination of the plasma pharmacokinetics and assessment of hematologic measurements.
resultsMusculoskeletal related adverse events were the most common. Transient troponin I levels increased in three patients, one of whom had an increase in tricuspid regurgitant velocity; however, no clinical signs were noted. Following an assessment of vital signs, tricuspid regurgitant velocity, electrocardiogram, serum biochemistry, hematology, urinalysis, and analysis of reported adverse events, SANGUINATE was found to be safe in stable sickle cell anemia patients.
conclusionsThe clinical trial met its primary objective of demonstrating an acceptable safety profile for SANGUINATE in patients with sickle cell anemia. This trial established the safety of SANGUINATE at both dose levels and permitted its advance to Phase II trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.