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Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates With Hyperbilirubinemia (JASMINE_204)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by InfaCare Pharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01887327
First received: June 24, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

Neonatal jaundice is the most common cause of hospital readmission for term- and near term infants and its management poses a significant burden on the healthcare system.

Infants with isoimmune hemolytic disease, such as ABO or Rhesus (Rh) incompatibility, or glucose-6-phosphate dehydrogenase (G6PD deficiency), have an increased rate of red cell destruction and, thus, an increase in bilirubin production. Newborn infants have immature liver function and do not conjugate bilirubin well, which results in accumulation of unconjugated bilirubin. Thus, bilirubin levels may rise rapidly and intervention may be required. At present, phototherapy (PT) is the most frequently used treatment for hyperbilirubinemia; it converts unconjugated bilirubin to less toxic water soluble photoisomers that are then excreted in the urine without need for conjugation. Infants who do not respond to PT are treated by exchange transfusion (ET), considered a therapy of last resort because of associated morbidity and mortality. Both PT and ET enhance the elimination of, but have no impact on the production of bilirubin.

Stannsoporfin is a heme oxygenase inhibitor that acts to reduce bilirubin production. It is being developed for the management of neonatal jaundice.


Condition Intervention Phase
Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Drug: stannsoporfin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Single Dose, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates

Resource links provided by NLM:


Further study details as provided by InfaCare Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Percent change from baseline in total serum bilirubin (TSB) (the baseline TSB is the TSB that qualifies for randomization) at 48 hours post-dose [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
    Percent change from baseline in total serum bilirubin (TSB) (the baseline TSB is the TSB that qualifies for randomization) at 48 hours post-dose


Secondary Outcome Measures:
  • Percent change from baseline in TSB (the baseline TSB is the TSB that qualifies for randomization) at 6, 12, 24, and 36 hours [ Time Frame: 6, 12, 24, and 36 hours ] [ Designated as safety issue: No ]
  • Total serum bilirubin area under the curve (AUC) above the baseline TSB (0 to 48 hours post-dose). [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
  • Peak serum bilirubin [ Time Frame: 0 to 48 hrs ] [ Designated as safety issue: No ]
  • Incidence of rebound hyperbilirubinemia defined as an increase in TSB above the age-specific threshold for initiating PT per the AAP Guidelines (AAP) following the discontinuation of the initial PT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of readmission to hospital for hyperbilirubinemia due to a TSB at or above the age specific threshold for PT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of clinical requirement for PT [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AE) and serious adverse events (SAE's) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Changes in vital sign measurements [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Results of physical exam (PE), including growth measurements [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Results of neurologic exam, including eye and hearing assessment [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Electrocardiographic (ECG) assessments [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests including hematology, serum chemistries, liver function and renal function tests [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Experimental: 3.0 mg/kg stannsoporfin
3.0 mg/kg stannsoporfin
Drug: stannsoporfin
Experimental: 4.5mg/kg stannsoporfin
4.5mg/kg stannsoporfin
Drug: stannsoporfin

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Term and near term infants ≥35 and ≤ 43 weeks GA, age 0-48 hours with ABO or Rh incompatibility (anti C, c, D, E or e) who are Coombs positive, or age 0-72 hours with G6PD deficiency
  2. Parental or guardian consent
  3. Birth weight ≥ 2500 grams
  4. At or above the age-specific threshold for initiating PT per the AAP guidelines based on measurement of TSB
  5. Parents agree to observe light precautions for 10 days post treatment

Exclusion Criteria:

1. Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin 2. Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) > 3 times ULN 3. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN 4. Any other clinically significant abnormalities on screening laboratory evaluation (including ECG) that in the opinion of the investigator makes the patient unsuitable for the clinical trial 5. Apgar score ≤6 at age 5 minutes 6. An unexplained existing rash or skin erythema 7. Prior exposure to PT 8. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto's disease is not exclusionary) 9. Cardio-respiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment 10. Any abnormal auditory or ophthalmologic findings on screening physical exam 11. Treatment or need for treatment in the neonate with medications that are photoreactive or may prolong the QT interval (erythromycin ointment for eye prophylaxis is permitted), or family history of Long QT syndrome QT syndrome (appendix C) 12. Known porphyrias or risk factors for porphyrias, including family history 13. A maternal history of systemic lupus erythematosus 14. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding 15. Maternal current drug or alcohol abuse, or maternal history of drug or alcohol abuse that, in the opinion of the Investigator, would not make the patient a suitable candidate for participation in the clinical trial 16. Significant congenital anomalies or infections 17. Risk of requiring surgery or exposure to operating room (OR) lights in the first 2 weeks of life 18. Persistent hypoglycemia (blood glucose <40 mg/dL) 19. Temperature instability defined as temperature consistently (3 consecutive times) <36ºC and/or >37.5ºC axillary 20. Use of IVIG or albumin prior to study drug administration 21. Post-delivery treatment with medications that are known or suspected to displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics) 22. Use of photosensitizing drugs or agents (appendix D) 23. Unwillingness for parents/guardians to adhere to recommendations regarding light precautions 24. Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial 25. Any other concurrent medical condition, which in the opinion of the Investigator, makes the patient unsuitable for the clinical trial

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  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: NCT01887327

Contacts
Contact: Paul Blake, MD 267-515-5859

Locations
United States, California
University of CA, San Francisco Recruiting
San Francisco, California, United States, 94145
Contact: Philip Rosenthal, MD    415-476-5892      
Principal Investigator: Philip Rosenthal, MD         
United States, Florida
Univ Florida Hospital Recruiting
Jacksonville, Florida, United States, 32209
Contact: Mark Hudak, MD    904-244-3508      
Principal Investigator: Mark Hudak, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Rajan Wadhawan, MD    407-303-2528      
Principal Investigator: Rajan Wadhawan, MD         
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Dan Stewart, MD    502-629-5820      
Principal Investigator: Dan Stewart, MD         
United States, New Jersey
Rutgers University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Onajovwe Fofah, MD    973-972-6753      
Principal Investigator: Onajovwe Fofah, MD         
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Warren Rosenfeld, MD    516-663-2288      
Principal Investigator: Warren Rosenfeld, MD         
Stoney Brook Univ Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Echezona Maduekwe, MD    631-444-7653      
Principal Investigator: Echezona Maduekwe, MD         
United States, North Carolina
Duke Univ Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Cotten, MD    919-681-6025      
Principal Investigator: Michael Cotten, MD         
WakeMed Health and Hospitals Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Stephen Kicklighter, MD    919-350-5585      
Principal Investigator: Stephen Kicklighter, MD         
United States, Ohio
Promedica Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jeffrey Blumer, MD, PhD    419-291-1115      
Principal Investigator: Jeffrey Blumer, MD, PhD         
Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jeffrey Blumer, MD    419-291-1115      
Principal Investigator: Jeffrey Blumer, MD         
United States, South Carolina
Medical Univ of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Carol Wagner, MD    843-792-8829      
Principal Investigator: Carol Wagner, MD         
United States, Texas
Univ Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Karen Shattuck, MD    832-340-2309      
Principal Investigator: Karen Shattuck, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Julie Shakib, DO    801-585-5349      
Principal Investigator: Julie Shakib, DO         
Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation
Investigators
Study Chair: Paul Blake InfaCare Pharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01887327     History of Changes
Other Study ID Numbers: 64,185-204
Study First Received: June 24, 2013
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:
G6PD deficiency
ABO incompatibility
Coombs positive ABO/RH incompatibility
intensive phototherapy in neonates
Hyperbilirubinemia
Neonatal Jaundice

Additional relevant MeSH terms:
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014