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Study · Not a test of the peptide alone · 2019

10 results

rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial.

Ley D, Hallberg B, Hansen-Pupp I, Dani C, Ramenghi LA, Marlow N, Beardsall K, Bhatti F, Dunger D, Higginson JD, Mahaveer A, Mezu-Ndubuisi OJ and 12 more

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Reynolds P, Giannantonio C, van Weissenbruch M, Barton N, Tocoian A, Hamdani M, Jochim E, Mangili A, Chung JK, Turner MA, Smith LEH, Hellström A

The Journal of pediatrics22 Nov 2018Cited by 124 (Europe PMC)

PMID30471715 (opens in a new tab)PMCIDPMC6389415 (opens in a new tab)DOI10.1016/j.jpeds.2018.10.033 (opens in a new tab)PepBankPUB-30471715
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone10

In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking IGF-1 (mecasermin).

  1. 01HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In extremely preterm infants, rhIGF-1/rhIGFBP-3 did not decrease retinopathy severity compared with standard neonatal care.

    In plain wordsIn extremely preterm infants, rhIGF-1/rhIGFBP-3 did not reduce retinopathy severity compared with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeRetinopathy severity
    Study

    n = 121

    Comparator
    Standard neonatal care
    Analysis
    Primary
    Outcome group
    Vision and retina · Eye

    Source sentences

    Summary
    rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence.
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  2. 02HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In extremely preterm infants, severe bronchopulmonary dysplasia occurred in 21.3% with rhIGF-1/rhIGFBP-3 versus 44.9% with standard care.

    In plain wordsIn extremely preterm infants, severe bronchopulmonary dysplasia was less frequent with rhIGF-1/rhIGFBP-3 than with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    DecreaseSevere bronchopulmonary dysplasia full analysis set
    Study

    n = 121

    Comparator
    Standard neonatal care
    Analysis
    Secondary
    Outcome group
    Lung injury and fibrosis · Respiratory

    Measurements

    Severe bronchopulmonary dysplasia, rhIGF-1/rhIGFBP-3
    21.3%
    full analysis set, treated
    Severe bronchopulmonary dysplasia, standard care
    44.9%
    full analysis set, standard care
    Relative decrease in severe bronchopulmonary dysplasia
    53%
    full analysis set
    P value for bronchopulmonary dysplasia severity distribution between groups
    0.04
    full analysis set, rhIGF-1/rhIGFBP-3 versus standard care

    Source sentences

    Summary
    There was, however, a 53% decrease in severe bronchopulmonary dysplasia in the full analysis set (21.3% treated vs 44.9% standard care), and an 89% decrease in the evaluable set (4.8% vs 44.9%; P = .04 and P = .02, respectively) for severity distribution between groups.
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  3. 03HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In extremely preterm infants, rhIGF-1/rhIGFBP-3 showed a nonsignificant decrease in severe intraventricular hemorrhage versus standard care, at 13.1% versus 23.3%.

    In plain wordsIn extremely preterm infants, severe brain hemorrhage was not significantly lower with rhIGF-1/rhIGFBP-3 than with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeSevere intraventricular hemorrhage full analysis set
    Study

    n = 121

    Comparator
    Standard neonatal care
    Analysis
    Secondary
    Outcome group
    Bleeding and clotting · Nervous system and cognition

    Measurements

    Grades 3-4 intraventricular hemorrhage, rhIGF-1/rhIGFBP-3
    13.1%
    full analysis set, treated
    Grades 3-4 intraventricular hemorrhage, standard care
    23.3%
    full analysis set, standard care

    Source sentences

    Summary
    There was also a nonsignificant trend toward decrease in grades 3-4 intraventricular hemorrhage in the full analysis set (13.1% vs 23.3%) and in the evaluable set (8.3% vs 23.3%).
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  4. 04HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In preterm infants, rhIGF-1/rhIGFBP-3 did not affect time to discharge compared with standard neonatal care.

    In plain wordsIn preterm infants, rhIGF-1/rhIGFBP-3 did not change time to discharge compared with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeTime to discharge
    Study

    n = 121

    Comparator
    Standard neonatal care
    Analysis
    Secondary
    Outcome group
    Intensive care and hospital outcomes · Whole body

    Source sentences

    Summary
    No effect was observed on time to discharge from neonatal care/growth measures.
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  5. 05HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In preterm infants, rhIGF-1/rhIGFBP-3 did not affect growth measures compared with standard neonatal care.

    In plain wordsIn preterm infants, rhIGF-1/rhIGFBP-3 did not change growth measures compared with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeGrowth measures
    Study

    n = 121

    Comparator
    Standard neonatal care
    Analysis
    Secondary
    Outcome group
    Linear growth · Whole body

    Source sentences

    Summary
    No effect was observed on time to discharge from neonatal care/growth measures.
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  6. 06HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In evaluable treated preterm infants, severe bronchopulmonary dysplasia occurred in 4.8% with rhIGF-1/rhIGFBP-3 versus 44.9% with standard care.

    In plain wordsIn evaluable treated preterm infants, severe bronchopulmonary dysplasia was less frequent with rhIGF-1/rhIGFBP-3 than with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    DecreaseSevere bronchopulmonary dysplasia evaluable set
    Study

    n: not reported in source

    Comparator
    Standard neonatal care
    Analysis
    Secondary
    Outcome group
    Lung injury and fibrosis · Respiratory

    Measurements

    Severe bronchopulmonary dysplasia, rhIGF-1/rhIGFBP-3
    4.8%
    evaluable set, treated
    Severe bronchopulmonary dysplasia, standard care
    44.9%
    evaluable set, standard care
    Relative decrease in severe bronchopulmonary dysplasia
    89%
    evaluable set
    P value for bronchopulmonary dysplasia severity distribution between groups
    0.02
    evaluable set, rhIGF-1/rhIGFBP-3 versus standard care

    Source sentences

    Summary
    There was, however, a 53% decrease in severe bronchopulmonary dysplasia in the full analysis set (21.3% treated vs 44.9% standard care), and an 89% decrease in the evaluable set (4.8% vs 44.9%; P = .04 and P = .02, respectively) for severity distribution between groups.
    2 context sentences
    Summary · context
    Overall, 61 infants were allocated to rhIGF-1/rhIGFBP-3, 60 to standard care (full analysis set); 24 of 61 treated infants achieved target exposure (evaluable set). rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence.
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  7. 07HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In evaluable treated preterm infants, rhIGF-1/rhIGFBP-3 showed a nonsignificant decrease in severe intraventricular hemorrhage versus standard care, at 8.3% versus 23.3%.

    In plain wordsIn evaluable treated preterm infants, severe brain hemorrhage was not significantly lower with rhIGF-1/rhIGFBP-3 than with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeSevere intraventricular hemorrhage evaluable set
    Study

    n: not reported in source

    Comparator
    Standard neonatal care
    Analysis
    Secondary
    Outcome group
    Bleeding and clotting · Nervous system and cognition

    Measurements

    Grades 3-4 intraventricular hemorrhage, rhIGF-1/rhIGFBP-3
    8.3%
    evaluable set, treated
    Grades 3-4 intraventricular hemorrhage, standard care
    23.3%
    evaluable set, standard care

    Source sentences

    Summary
    There was also a nonsignificant trend toward decrease in grades 3-4 intraventricular hemorrhage in the full analysis set (13.1% vs 23.3%) and in the evaluable set (8.3% vs 23.3%).
    2 context sentences
    Summary · context
    Overall, 61 infants were allocated to rhIGF-1/rhIGFBP-3, 60 to standard care (full analysis set); 24 of 61 treated infants achieved target exposure (evaluable set). rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence.
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  8. 08HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialEfficacy outcome

    In extremely preterm infants, rhIGF-1/rhIGFBP-3 did not decrease retinopathy occurrence compared with standard neonatal care.

    In plain wordsIn extremely preterm infants, rhIGF-1/rhIGFBP-3 did not reduce retinopathy occurrence compared with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    No significant changeRetinopathy occurrence
    Study

    n = 121

    Comparator
    Standard neonatal care
    Outcome group
    Vision and retina · Eye

    Source sentences

    Summary
    rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence.
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  9. 09HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialSafety outcome

    In preterm infants, fatal serious adverse events occurred in 19.7% receiving rhIGF-1/rhIGFBP-3 versus 11.7% receiving standard care.

    In plain wordsIn preterm infants, fatal serious adverse events were reported more often with rhIGF-1/rhIGFBP-3 than with standard care.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    IncreaseFatal serious adverse events
    Study

    n = 121

    Comparator
    Standard neonatal care
    Outcome group
    Mortality · Whole body

    Measurements

    Fatal serious adverse events, rhIGF-1/rhIGFBP-3
    19.7%
    12/61 treated infants
    Fatal serious adverse events, standard care
    11.7%
    7/60 control infants
    Treated infants with fatal serious adverse events
    12 infants
    rhIGF-1/rhIGFBP-3, 12/61 treated infants
    Control infants with fatal serious adverse events
    7 infants
    standard care, 7/60 control infants
    Treated infants assessed for fatal serious adverse events
    61 infants
    rhIGF-1/rhIGFBP-3, denominator of 12/61
    Control infants assessed for fatal serious adverse events
    60 infants
    standard care, denominator of 7/60

    Source sentences

    Summary
    Fatal serious adverse events were reported in 19.7% of treated infants (12/61) and 11.7% of control infants (7/60).
    1 context sentence
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

  10. 10HumanNot a test of IGF-1 (mecasermin) aloneRandomized controlled trialPharmacokinetics

    Among treated preterm infants, 24 of 61 achieved the target exposure to rhIGF-1/rhIGFBP-3.

    In plain wordsAmong treated preterm infants, 24 of 61 achieved the target exposure to rhIGF-1/rhIGFBP-3.

    Peptide
    IGF-1 (mecasermin)
    Outcome
    Not applicableTarget exposure achieved
    Study

    n = 61

    Outcome group
    Pharmacokinetics · Pharmacology

    Measurements

    Infants achieving target exposure
    24 infants
    of 61 treated infants; evaluable set
    Target proportion of IGF-1 measurements within the target concentration range
    ≥ 70%
    target exposure criterion, IGF-1 measurements within 28-109 µg/L
    Target IGF-1 concentration range
    28 to 109 µg/L
    target exposure criterion
    Target proportion of intended therapy duration
    ≥ 70%
    target exposure criterion

    Source sentences

    Summary
    Overall, 61 infants were allocated to rhIGF-1/rhIGFBP-3, 60 to standard care (full analysis set); 24 of 61 treated infants achieved target exposure (evaluable set).
    2 context sentences
    Summary · context
    Target exposure was ≥70% IGF-1 measurements within 28-109 µg/L and ≥70% intended therapy duration.
    Summary · context
    Infants born at a gestational age of 230/7 weeks to 276/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from 6/7 weeks) or standard neonatal care, with follow-up to a…

    In this study, IGF-1 (mecasermin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking IGF-1 (mecasermin).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 1 ongoing · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

Active, not recruitingPhase 2NCT03253263

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

OHB Neonatology Ltd.n = 2959 May 2019 to est. 21 Jan 2028

Bronchopulmonary Dysplasia · Chronic Lung Disease of Prematurity · Intraventricular Hemorrhage · Retinopathy of Prematurity (ROP)

Trial pageClinicalTrials.govUpdated 3 Aug 2026
CompletedPhase 2Results postedNCT01096784

IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

Shiren = 12118 Jun 2010 to 30 Mar 2016

Retinopathy of Prematurity (ROP)

Trial pageClinicalTrials.govUpdated 14 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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