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Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease

Abstract

Objective

To evaluate the efficacy and safety of tin mesoporphyrin (SnMP) in neonates with hyperbilirubinemia (HB) due to hemolysis.

Study Design

This multicenter, placebo-controlled phase 2b study (NCT01887327) randomized newborns (35–42 weeks) with hemolysis started on phototherapy (PT) to placebo (Ctrl), SnMP 3.0 mg/kg, or SnMP 4.5 mg/kg given once IM within 30 min of initiation of PT.

Results

In all, 91 patients were randomized (Ctrl: n = 30; 3 mg/kg SnMP: n = 30; 4.5 mg/kg SnMP: n = 31). At 48 h TSB significantly increased in Ctrl by 17.5% (95% CI 5.6–30.7; p = 0.004) and significantly decreased by −13% (95% CI −21.7 to −3.2; p = 0.013) in the 3.0 mg/kg and by −10.5% (95% CI −19.4 to −0.6; p = 0.041) in the 4.5 mg/kg group. Decreases in SnMP groups were significant (p < 0.0001) vs Ctrl.

Conclusion

SnMP with PT significantly reduced TSB by 48 h. SnMP may be useful as a treatment for HB in neonates with hemolysis.

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Fig. 1: Change in TSB over 48 h after treatment.

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Acknowledgements

Infacare Pharmaceuticals designed this study to meet Phase 2B requirements of the FDA. They chose clinical sites, provided study oversight, and collected data. They were not involved in the manuscript preparation but have reviewed the manuscript. Data for this article were collected by Infacare but were analyzed independently by the authors.

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Contributions

Dr. Rosenfeld was involved in the study design, drafted the original manuscript and reviewed, and revised the manuscript. Dr. Hudak coordinated and participated in Data analyses, reviewed and revised the manuscript. Dr. Gautam provided statistical analysis and reviewed the manuscript. Dr. Ruiz was involved in study design and reviewed and revised manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Warren N. Rosenfeld.

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The authors declare no competing interests.

Ethics approval and consent to participate

The study protocol, amendments, and informed consent forms were reviewed and approved by the Institutional Review Boards at each study site. This study was performed in accordance with the Declaration of Helsinki.

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Rosenfeld, W.N., Hudak, M.L., Ruiz, N. et al. Stannsoporfin with phototherapy to treat hyperbilirubinemia in newborn hemolytic disease. J Perinatol 42, 110–115 (2022). https://doi.org/10.1038/s41372-021-01223-2

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