NCT00076960

Brief Summary

The purpose of this protocol is to make Stanate (TM) \[stannsoporfin, tin-mesoporphyrin\] available to infants who meet the following criteria:

  1. 1.the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
  2. 2.the infant requires an exchange transfusion; and
  3. 3.the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2004

Completed
Last Updated

October 15, 2019

Status Verified

January 1, 2016

First QC Date

February 6, 2004

Last Update Submit

October 11, 2019

Conditions

Neonatal JaundiceHyperbilirubinemia

Keywords

hyperbilirubinemiajaundicetin-mesoporphyrinstannsoporfinexchange transfusionneonatal hyperbilirubinemia

Interventions

Stanate (TM) [stannsoporfin, tin-mesoporphyrin]DRUG

Treatment with 4.5 mg/kg

Eligibility Criteria

Age12 Hours - 1 Week
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Term or near term neonate * Elevated serum bilirubin * Failing phototherapy * Requires exchange transfusion * Family refuses exchange transfusion on religious grounds

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (1)

  • Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374.

    PMID: 11731664BACKGROUND

MeSH Terms

Conditions

Jaundice, NeonatalHyperbilirubinemiaJaundiceHyperbilirubinemia, Neonatal

Interventions

tin mesoporphyrin

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2004

First Posted

February 10, 2004

Last Updated

October 15, 2019

Record last verified: 2016-01

Locations

US(1)