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NCT00076960 Clinical Trial

Compassionate Use of Stanate (TM) [Stannsoporfin]

Neonatal Jaundice Clinical Trial

Official title:
Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT00076960
Other study ID # 99A
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2016
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The purpose of this protocol is to make Stanate (TM) [stannsoporfin, tin-mesoporphyrin] 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. the infant requires an exchange transfusion; and

3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.

Other known NCT identifiers
  • NCT01183988

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Week
Eligibility - Term or near term neonate

- Elevated serum bilirubin

- Failing phototherapy

- Requires exchange transfusion

- Family refuses exchange transfusion on religious grounds

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Treatment with 4.5 mg/kg

Locations
Country Name City State
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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