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Compassionate Use of Stannsoporfin in Addition to Phototherapy to Reduce the Need for Exchange Transfusions in Term and Near-Term Infants

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01183988
First received: August 16, 2010
Last updated: August 17, 2010
Last verified: August 2010
History of Changes
  Purpose

The purpose of this protocol is to make Stanate® (Stannsoporfin, tin-mesoporphyin) available to infants who meet the following criteria: 1) the infant has a very high level of bilirubin without an adequate clinical response to phototherapy 2)requires exchange transfusion and 3) the family refuses to allow the administration of blood products, particularly on religious grounds, such as the Jehovah's Witness Community.


Condition Intervention
Neonatal Hyperbilirubinemia
Neonatal Jaundice
Jaundice
Hyperbilirubinemia
 Drug: Stanate®

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: Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions in Term and Near-Term Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InfaCare Pharmaceuticals Corporation:

Primary Outcome Measures:
  • safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Total serum builirubin, CBC, LFTs and other safety assessments are done over the seven day period following drug administration. Adverse events are collected for 30 days.


Estimated Enrollment: 50
Study Start Date: October 2003
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stanate® Drug: Stanate®
Single IM injection of 4.5 mg/kg

  Eligibility

Ages Eligible for Study:   up to 1 Week
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Term or near term neonate
  2. Elevated serum bilirubin
  3. Failing Phototherapy
  4. Requires Exchange Transfusion
  5. Family refuses exchange transfusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183988

Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation
Investigators
Study Director: Warren W Wasiewski, MD InfaCare Pharmaceutical Corporation
  More Information

Publications:

Responsible Party: Warren W. Wasiewski, MD, Chief Medical Officer, InfaCare Pharmaceutical Corporation
ClinicalTrials.gov Identifier: NCT01183988     History of Changes
Other Study ID Numbers: 64,185-99A-3W
Study First Received: August 16, 2010
Last Updated: August 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:
hyperbilirubinemia
jaundice
tin-mesoporphyrin
stannsoporfin
exchange transfusion

Additional relevant MeSH terms:
Hyperbilirubinemia
Jaundice
Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
 Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 16, 2013