Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

NCT04379180 | Unknown FDA Drug

• 1 other identifier: 2020_PPHN_001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pulmonary Hypertension of the Newborn

Outcome Measures

Primary Outcomes (2)

• Oxygenation index

  Oxygenation index=(fraction of inspired oxygen\*mean airway pressure)/the partial pressure of arterial oxygen

  The first 72 hours of the initial treatment

• The change of hemodynamics

  * Pulmonary artery pressure (mmHg) * Alveolar-arterial gradient (mmHg)

  Through study completion, an average of 5 days

Secondary Outcomes (6)

• Duration of hospitalization

  Within the first 28 days of patients' life

• Death

  Within the first 28 days of patients' life

• Adverse events

  Through study completion, an average of 5 days

• Sequelae of PPHN

  Through study completion and a 6-month visit

• The need of extra support

  Through study completion, an average of 5 days

Study Arms (1)

Treatment(bosentan, sildenafil and tadalafil)

Drug: Bosentan Tablets; Drug: Sildenafil Tablet; Drug: Tadalafil Tablets

Interventions

Bosentan Tablets DRUG

2mg/kg, bid

Treatment(bosentan, sildenafil and tadalafil)

Sildenafil Tablet DRUG

1mg/kg, q6h/q8h

Treatment(bosentan, sildenafil and tadalafil)

Tadalafil Tablets DRUG

1mg/kg, qd

Treatment(bosentan, sildenafil and tadalafil)

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates suffered from persistent pulmonary hypertension

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong University: lead
• West China Second University Hospital: collaborator

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Interventions

Bosentan; Sildenafil Citrate; Tadalafil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbolines; Pyridines; Indole Alkaloids; Indoles; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 7, 2020
• Study Start: April 26, 2020
• Primary Completion: February 26, 2023
• Study Completion: May 30, 2023
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

CN (1)