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Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

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ClinicalTrials.gov Identifier: NCT04379180
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
West China Second University Hospital
Information provided by (Responsible Party):
Wei Zhao, Shandong University

Study Description
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Brief Summary:
The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.

Condition or disease Intervention/treatment
Persistent Pulmonary Hypertension of the Newborn Drug: Bosentan Tablets Drug: Sildenafil Tablet Drug: Tadalafil Tablets

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Pharmacokinetics and Dosage Individualization of Bosentan, Sildenafil and Tadalafil in Persistent Pulmonary Hypertension of the Newborn
Estimated Study Start Date : April 26, 2020
Estimated Primary Completion Date : February 26, 2023
Estimated Study Completion Date : May 30, 2023

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment(bosentan, sildenafil and tadalafil) Drug: Bosentan Tablets
2mg/kg, bid

Drug: Sildenafil Tablet
1mg/kg, q6h/q8h

Drug: Tadalafil Tablets
1mg/kg, qd


Outcome Measures
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Primary Outcome Measures :
  1. Oxygenation index [ Time Frame: The first 72 hours of the initial treatment ]
    Oxygenation index=(fraction of inspired oxygen*mean airway pressure)/the partial pressure of arterial oxygen

  2. The change of hemodynamics [ Time Frame: Through study completion, an average of 5 days ]
    • Pulmonary artery pressure (mmHg)
    • Alveolar-arterial gradient (mmHg)


Secondary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: Within the first 28 days of patients' life ]
    Duration of initial therapy

  2. Death [ Time Frame: Within the first 28 days of patients' life ]
    Death in the first 28 days of life

  3. Adverse events [ Time Frame: Through study completion, an average of 5 days ]
    Drug-related adverse events and serious adverse events

  4. Sequelae of PPHN [ Time Frame: Through study completion and a 6-month visit ]
    Including cerebral palsy, hearing impairment, neurodevelopmental outcome etc

  5. The need of extra support [ Time Frame: Through study completion, an average of 5 days ]
    Besides the initial therapy (bosentan, sildenafil and/or tadalafil), other support such as inhaled nitric oxide (iNO), inotropic agents or Extracorporeal Membrane Oxygenation (ECMO)

  6. Pulse oxygen saturation [ Time Frame: The first 72 hours of the initial treatment ]
    Pulse oxygen saturation（%）


Eligibility Criteria
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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates suffered from persistent pulmonary hypertension
Criteria

Inclusion Criteria:

  • Age: postnatal age ≤ 28 days;
  • Patients have been diagnosed with PPHN;
  • Bosentan, sildenafil and/or tadalafil used as part of regular treatment.
  • Parental written consent

Exclusion Criteria:

  • Expected survival time less than the treatment cycle;
  • Major congenital malformations;
  • Undergoing surgery within the first week of life;
  • Receiving other systemic trial drug therapy;
  • Other factors that the researcher considers unsuitable for inclusion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379180


Locations
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China, Sichuan
West China Second University Hospital
Chengdu, Sichuan, China, 610041
Contact: Wei Zhao, Ph.D    86053188383308    zhao4wei2@hotmail.com   
Sponsors and Collaborators
Shandong University
West China Second University Hospital
More Information
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Responsible Party: Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
ClinicalTrials.gov Identifier: NCT04379180    
Other Study ID Numbers: 2020_PPHN_001
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Bosentan
Sildenafil Citrate
 Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Antihypertensive Agents
Endothelin Receptor Antagonists