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NCT00115544
An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion
Phase 2 trial testing Stanate in Hyperbilirubinemia in 55 participants. Completed in 1 July 2006.
1 July 2006
Quick facts
| Lead sponsor | InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 1 September 2005 |
| Primary completion | 1 July 2006 |
| Estimated completion | 1 July 2006 |
| Sites | 1 location across Vietnam |
Drugs / interventions tested
- Stanate — full drug profile →
Conditions studied
- Hyperbilirubinemia — all drugs for Hyperbilirubinemia →
Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company — full company profile →
Who can join
Adults 2 Days to 7 Days, any sex, with Hyperbilirubinemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters
Time frame: 30 days with long term f/u
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00115544
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hyperbilirubinemia
Currently open trials in the same condition.
- NCT06421844 — A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images · recruiting
Other InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company trials
Trials by the same sponsor.
- NCT02000830 — Follow up Study of Patients Having Participated in Clinical Trial 64,185-204 · completed
- NCT01887327 — Stannsoporfin With Light Therapy for Newborn Babies With Jaundice · Phase 2 · completed
- NCT02033096 — Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993) · completed
- NCT00076960 — Compassionate Use of Stanate (TM) [Stannsoporfin] · no longer available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00115544 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Last refreshed: 11 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00115544.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing