Safety and Pharmacology of Stanate

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Hospital of Pediatrics, Vietnam
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00115544
First received: June 22, 2005
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.


Condition Intervention Phase
Hyperbilirubinemia
Drug: Stanate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion

Resource links provided by NLM:


Further study details as provided by InfaCare Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters [ Time Frame: 30 days with long term f/u ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: September 2005
Estimated Study Completion Date: November 2015
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
stannsoporfin 0.75mg/kg
Drug: Stanate
Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
Experimental: 2
stannsoporfin 1.5mg/kg
Drug: Stanate
Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
Placebo Comparator: 3
saline injection
Drug: Stanate
Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion

Detailed Description:

The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy in a non randomised sequential open label cohort design, in 55 patients. Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion. The first cohort began at a dose of stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5 mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted of hepatic, renal and hematologic clinical laboratory tests along with serial physical examinations. Long term follow up of all patients to age 6 is planned.

  Eligibility

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

Inclusion Criteria:

  • Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

Exclusion Criteria:

  • No parental consent
  • Major known congenital anomaly
  • Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
  • Phenobarbital use in either child or mother (30 days prior to child's birth)
  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: NCT00115544

Locations
Vietnam
National hospital of pediatrics
Hanoi, Vietnam
Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation
National Hospital of Pediatrics, Vietnam
  More Information

No publications provided

Responsible Party: InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00115544     History of Changes
Other Study ID Numbers: 64,185-06-2W, no grant or contracts
Study First Received: June 22, 2005
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:
neonatal
jaundice
hyperbilirubinemia

Additional relevant MeSH terms:
Hyperbilirubinemia
Pathologic Processes
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014