Trial reportPediatric blood & cancer2012
Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG Phase III Clinical Trial.
Trial report in Pediatric blood & cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006400 (Pediatric Hydroxyurea Phase III Clinical Trial), which is not on this map. Cited by 21 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG)
Who cites it
21 citing papers in PubMed, 6 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2023Pooled it
- Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022Pooled it
- Interventions for preventing silent cerebral infarcts in people with sickle cell disease.The Cochrane database of systematic reviews · 2020Pooled it
- Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Interventions for preventing silent cerebral infarcts in people with sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017Pooled it
- Trial
- Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia.Journal of clinical pharmacology · 2016Trial
- From infancy to adolescence: fifteen years of continuous treatment with hydroxyurea in sickle cell anemia.Medicine · 2014Trial
- Acute lymphoblastic leukemia in a β-thalassemia intermedia child: A case report.World journal of clinical pediatrics · 2020Article
- Ruxolitinib-based combinations in the treatment of myelofibrosis: worth looking forward to.Annals of hematology · 2020Review
- The Evolving Pharmacotherapeutic Landscape for the Treatment of Sickle Cell Disease.Mediterranean journal of hematology and infectious diseases · 2020Review
- Rational Drug Design of Peptide-Based Therapies for Sickle Cell Disease.Molecules (Basel, Switzerland) · 2019Review
- Occurrence of acute myeloid leukemia in hydroxyurea-treated sickle cell disease patient.Cancer biology & therapy · 2019Article
- Developmental Injury to the Cerebellar Cortex Following Hydroxyurea Treatment in Early Postnatal Life: An Immunohistochemical and Electron Microscopic Study.Neurotoxicity research · 2017Article
- Pediatric sickle cell disease: past successes and future challenges.Pediatric research · 2017Review
- Risk of individual malignant neoplasms in patients with sickle cell disease: English national record linkage study.Journal of the Royal Society of Medicine · 2016Article
- Translating sickle cell guidelines into practice for primary care providers with Project ECHO.Medical education online · 2016Article
- Review
- Optimal therapy for polycythemia vera and essential thrombocythemia can only be determined by the completion of randomized clinical trials.Haematologica · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundThe laboratory and clinical benefits of hydroxyurea therapy for children with sickle cell anemia (SCA) are well recognized, but treatment in young patients is limited in part by concerns about long-term genotoxicity, and specifically possible carcinogenicity. PROCEDURE: The Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) was a multicenter double-blinded placebo-controlled randomized clinical trial (NCT00006400) testing whether hydroxyurea could prevent chronic organ damage in very young patients with SCA. An important secondary objective was the measurement of acquired genotoxicity using three laboratory assays: chromosomal karyotype, illegitimate VDJ recombination events, and micronucleated reticulocyte formation.
resultsOur data indicate that hydroxyurea treatment was not associated with any significant increases in genotoxicity compared to placebo treatment.
conclusionsThese data provide additional support to the safety profile of hydroxyurea for young patients with SCA, and suggest that genotoxicity in this patient population is low.
Indexed as
Identifiers
What OpenQuestion holds
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.