Compassionate Use of Stanate (TM) [Stannsoporfin] | NCT00076960

Studies
Compassionate Use of Stanate (TM) [Stannsoporfin]

NCT00076960

Sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Status

No longer available

Last Update Posted

Oct 15, 2019Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Neonatal Jaundice
Hyperbilirubinemia

Interventions

Stanate (TM) [stannsoporfin, tin-mesoporphyrin]

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

No longer available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 6, 2004

First Submission Date that Met QC Criteria

Feb 9, 2004

First Posted Date

Feb 10, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2019

Last Update Posted Date

Oct 15, 2019Actual

Description Module

Brief Summary

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

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

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Stanate (TM) [stannsoporfin, tin-mesoporphyrin]	Drug	Treatment with 4.5 mg/kg

Eligibility Module

Eligibility Criteria

Term or near term neonate
Elevated serum bilirubin
Failing phototherapy
Requires exchange transfusion
Family refuses exchange transfusion on religious grounds

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Hours

Maximum Age

1 Week

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11731664	Background	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.

ID	Term
D007567	Jaundice, Neonatal
D006932	Hyperbilirubinemia
D007565	Jaundice
D051556	Hyperbilirubinemia, Neonatal

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms