Skip to main content
OpenTrials
Completed

NCT Number: NCT00115544

Safety and Pharmacology of Stanate

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperbilirubinemia Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

2 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National hospital of pediatrics

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stanate

Drug

Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion

Primary outcomes

  1. Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters

    Time frame: 30 days with long term f/u

Sponsors and collaborators

Lead sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Industry

Collaborators

  • National Children's Hospital, Vietnam

Registry information

Official study title

An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 23, 2005
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.