Clinical Trial: Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates With Hyperbilirubinemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:
Sponsor: InfaCare Pharmaceuticals Corporation

Current Primary Outcome: 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 ]

Percent change from baseline in total serum bilirubin (TSB) (the baseline TSB is the TSB that qualifies for randomization) at 48 hours post-dose


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Total serum bilirubin area under the curve (AUC) above the baseline TSB (0 to 48 hours post-dose). [ Time Frame: 48 hrs ]
  • Peak serum bilirubin [ Time Frame: 0 to 48 hrs ]
  • 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 ]
  • Incidence of readmission to hospital for hyperbilirubinemia due to a TSB at or above the age specific threshold for PT [ Time Frame: 30 days ]
  • Duration of clinical requirement for PT [ Time Frame: 30 days ]
  • Incidence of adverse events (AE) and serious adverse events (SAE's) [ Time Frame: 30 days ]
  • Changes in vital sign measurements [ Time Frame: 30 days ]
  • Results of physical exam (PE), including growth measurements [ Time Frame: 30 days ]
  • Results of neurologic exam, including eye and hearing assessment [ Time Frame: 30 days ]
  • Electrocardiographic (ECG) assessments [ Time Frame: 14 days ]
  • Clinical laboratory tests including hematology, serum chemistries, liver function and renal function tests [ Time Frame: 30 days ]


Original Secondary Outcome:

  • 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 ]
  • Total serum bilirubin area under the curve (AUC) above the baseline TSB (0 to 48 hours post-dose). [ Time Frame: 48 hrs ]
  • Peak serum bilirubin [ Time Frame: 0 to 48 hrs ]
  • 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 ]
  • Incidence of readmission to hospital for hyperbilirubinemia due to a TSB at or above the age specific threshold for PT [ Time Frame: 30 days ]
  • Duration of clinical requirement for PT [ Time Frame: 30 days ]
  • Incidence of adverse events (AE) and serious adverse events (SAE's) [ Time Frame: 30 d ]
  • Changes in vital sign measurements [ Time Frame: 30 d ]
  • Results of physical exam (PE), including growth measurements [ Time Frame: 30 d ]
  • Results of neurologic exam, including eye and hearing assessment [ Time Frame: 30 d ]
  • Electrocardiographic (ECG) assessments [ Time Frame: 14 d ]
  • Clinical laboratory tests including hematology, serum chemistries, liver function and renal function tests [ Time Frame: 30 d ]


Information By: InfaCare Pharmaceuticals Corporation

Dates:
Date Received: June 24, 2013
Date Started: September 2013
Date Completion:
Last Updated: March 25, 2016
Last Verified: March 2016