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NCT02685189
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)
trial testing Previous exposure to stannsoporfin in Hyperbilirubinemia in 55 participants. Terminated before completion.
10 May 2016
Quick facts
| Lead sponsor | InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 1 July 2006 |
| Primary completion | 10 May 2016 |
| Estimated completion | 10 May 2016 |
Drugs / interventions tested
- Previous exposure to stannsoporfin
Conditions studied
- Hyperbilirubinemia — all drugs for Hyperbilirubinemia →
Sponsor
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company — full company profile →
Who can join
Adults 1 Day to 60 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.
-
NEUROLOGICAL EXAMINATION; Child Behavior Check List
Time frame: 10 years
Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients
Sponsor's own description
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02685189
- 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 NCT02685189 (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/NCT02685189.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing