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:
InfaCare Pharmaceuticals Corporation
Information provided by:
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01183988
First received: August 16, 2010
Last updated: August 17, 2010
Last verified: August 2010
| Tracking Information | |||||
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| First Received Date ICMJE | August 16, 2010 | ||||
| Last Updated Date | August 17, 2010 | ||||
| Start Date ICMJE | October 2003 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01183988 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Compassionate Use of Stannsoporfin in Addition to Phototherapy to Reduce the Need for Exchange Transfusions in Term and Near-Term Infants | ||||
| Official Title ICMJE | Compassionate Use of Stannsoporfin as an Adjuvant to Phototherapy to Reduce the Need for Exchange Transfusions in Term and Near-Term Infants | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Stanate®
Single IM injection of 4.5 mg/kg |
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| Study Arm (s) | Experimental: Stanate®
Intervention: Drug: Stanate® |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | up to 1 Week | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01183988 | ||||
| Other Study ID Numbers ICMJE | 64,185-99A-3W | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Warren W. Wasiewski, MD, Chief Medical Officer, InfaCare Pharmaceutical Corporation | ||||
| Study Sponsor ICMJE | InfaCare Pharmaceuticals Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | InfaCare Pharmaceuticals Corporation | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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