Persistent Pulmonary Hypertension of the Newborn (FUTURE 4)

This study has been terminated.
(To be compliant with the timelines as agreed with Pediatric Committee (PC) within the Pediatric Investigational Plan)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01389856
First received: June 30, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy.


Condition Intervention Phase
Persistent Fetal Circulation Syndrome
Drug: Bosentan
Drug: Matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-blind, Placebo-controlled, Randomized, Prospective Study of Bosentan as Adjunctive Therapy to Inhaled Nitric Oxide in the Management of Persistent Pulmonary Hypertension of the Newborn (PPHN)

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Proportion of patients with treatment failure [ Time Frame: From baseline to up to 14 days ] [ Designated as safety issue: No ]

    Exploratory Endpoint:

    Proportion of patients with treatment failure:

    • Need for extra corporeal membrane oxygenation (ECMO) or
    • Initiation of alternative pulmonary vasodilator


Secondary Outcome Measures:
  • Time to complete weaning from inhaled nitric oxide (iNO) [ Time Frame: From baseline to up to 14 days ] [ Designated as safety issue: No ]

    Exploratory Endpoint:

    Time to complete weaning from inhaled nitric oxide (iNO)



Enrollment: 23
Study Start Date: December 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bosentan
Drug: Bosentan
2 mg/kg of weight at birth twice daily (b.i.d); dispersible and quadrisectible 32 mg tablet of bosentan by nasogastric or orogastric tube.
Other Name: Tracleer
Placebo Comparator: 2
Matching placebo
Drug: Matching placebo
2 mg/kg of weight at birth twice daily (b.i.d); dispersible and quadrisectible 32 mg tablet of matching placebo by nasogastric or orogastric tube.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent by the parent(s) or the legal representative(s).
  2. Term and near term newborns (gestational age > 34 weeks).
  3. Post natal age ≥ 12 hours and < 7 days.
  4. Weight at birth ≥ 2,000 g.
  5. Idiopathic PPHN or PPHN due to parenchymal lung disease
  6. Documented diagnosis of pulmonary hypertension (PH) confirmed by echocardiography:
  7. Need for continued iNO at a dose > 10ppm after at least 4 hours of continuous iNO treatment.
  8. Two oxygenation index (OI) values ≥ 12 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving iNO treatment.
  9. Mechanical ventilation with fraction of inspired oxygen (FiO2) ≥ 50% at randomization.

Exclusion Criteria:

  1. PH associated with conditions other than PPHN.
  2. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO).
  3. Lethal congenital anomalies.
  4. Congenital Diaphragmatic Hernia.
  5. Significant structural cardiac anomalies..
  6. Medically significant pneumothorax.
  7. Active seizures.
  8. Expected duration of mechanical ventilation of less than 48 hours.
  9. Mean systemic blood pressure < 35 mmHg despite therapy with volume infusions and cardiotonic support.
  10. Hepatic failure or all conditions with ALT values > 2 x ULN.
  11. Renal function impairment such as serum creatinine > 3 x ULN or anuria.
  12. Known intracranial hemorrhage grade III or IV.
  13. Either hemoglobin or hematocrit level < 75% of the LLN.
  14. Thrombocytopenia (platelet count < 50,000 cells /µL).
  15. Leukopenia (WBC < 2,500 cells/ µL).
  16. Any condition precluding the use of a nasogastric/orogastric tube.
  17. Administration of prohibited medication prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389856

  Show 26 Study Locations
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01389856     History of Changes
Other Study ID Numbers: AC-052-391
Study First Received: June 30, 2011
Last Updated: February 11, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Ethikkommission
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Korea: Institutional Review Board
Korea: Ministry of Food and Drug Safety
Singapore: Institutional Review Board
Singapore: Health Sciences Authority
Russia: Ministry of Health of the Russian Federation

Keywords provided by Actelion:
Persistent pulmonary hypertension, newborn
PPHN

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Persistent Fetal Circulation Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014