Trial · NCT00850993
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
NCT00850993, Phase 2, Terminated, InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia. Trials, record NCT00850993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00850993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
- NCT number
- NCT00850993
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Conditions
- Hyperbilirubinemia, Neonatal
- Interventions
- Stannsoporfin, Placebo, PhotoTherapy (as needed)
- First posted
- 2009-02-25
- Last updated
- 2019-10-30
- Other registries' IDs
- eudract:2009-017434-45
- Results first posted
- 2014-08-29
- Limitations and caveats
It should be noted that the study was discontinued before enrollment of the full 4.5 mg/kg cohort,and therefore, the stannsoporfin 4.5 mg/kg treatment group included 8 patients and the placebo group included 15 patients.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. | Baseline, 48 hours | The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time \[(TSB - PT threshold/PT threshold) x 100%). |
| Primary | Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Baseline, 48 hrs | Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. | Baseline, 48 hours | Intent-to-treat population (ITT) | percentage difference from PT threshold | MEDIAN |
| PRIMARY | Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Baseline, 48 hrs | Intention-to-treat | mg/dL | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. | Cohort 1: Stannsoporfin 1.5 mg/kg | -12.30 | Full Range -55.7 to 0.3 | percentage difference from PT threshold | |
| Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. | Cohort 2: Stannsoporfin 3.0 mg/kg | -9.05 | Full Range -54.8 to 12.0 | percentage difference from PT threshold | |
| Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. | Cohort 3: Stannsoporfin 4.5 mg/kg | -19.95 | Full Range -59.0 to -5.0 | percentage difference from PT threshold | |
| Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. | Placebo Control | -5.7 | Full Range -42.1 to 22.2 | percentage difference from PT threshold | |
| Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Cohort 1: Stannsoporfin 1.5 mg/kg | at Baseline | 7.80 | Full Range 4.3 to 12.0 | mg/dL |
| Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Cohort 2: Stannsoporfin 3.0 mg/kg | at Baseline | 8.45 | Full Range 5.5 to 10.4 | mg/dL |
| Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Cohort 3: Stannsoporfin 4.5 mg/kg | at Baseline | 9.35 | Full Range 6.4 to 12.8 | mg/dL |
| Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Placebo Control | at Baseline | 8.00 | Full Range 4.6 to 11.9 | mg/dL |
| Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Cohort 1: Stannsoporfin 1.5 mg/kg | at 48 hours | 10.90 | Full Range 3.3 to 13.5 | mg/dL |
| Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population | Cohort 2: Stannsoporfin 3.0 mg/kg | at 48 hours | 11.65 | Full Range 4.2 to 14.1 | mg/dL |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Stannsoporfin 1.5 mg/kg | 17 | |
| Overall Study | STARTED | Cohort 2: Stannsoporfin 3.0 mg/kg | 18 | |
| Overall Study | STARTED | Cohort 3: Stannsoporfin 4.5 mg/kg | 8 | |
| Overall Study | STARTED | Cohort 4: Placebo Control | 15 | |
| Overall Study | Safety | Cohort 1: Stannsoporfin 1.5 mg/kg | 17 | |
| Overall Study | Safety | Cohort 2: Stannsoporfin 3.0 mg/kg | 18 | |
| Overall Study | Safety | Cohort 3: Stannsoporfin 4.5 mg/kg | 8 | |
| Overall Study | Safety | Cohort 4: Placebo Control | 15 | |
| Overall Study | Intent-to-treat | Cohort 1: Stannsoporfin 1.5 mg/kg | 17 | |
| Overall Study | Intent-to-treat | Cohort 2: Stannsoporfin 3.0 mg/kg | 18 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Stannsoporfin 1.5 mg/kg | 0 | 17 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Stannsoporfin 3.0 mg/kg | 1 | 18 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3: Stannsoporfin 4.5 mg/kg | 2 | 8 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Control | 0 | 15 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 1: Stannsoporfin 1.5 mg/kg | 1 | 17 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 2: Stannsoporfin 3.0 mg/kg | 2 | 18 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cohort 3: Stannsoporfin 4.5 mg/kg | 0 | 8 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Control | 0 | 15 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1: Stannsoporfin 1.5 mg/kg | 0 | 17 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2: Stannsoporfin 3.0 mg/kg | 0 | 18 | 0 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Stannsoporfin 1.5 mg/kg | 0 | 17 |
| Total, all-cause mortality | Cohort 2: Stannsoporfin 3.0 mg/kg | 0 | 18 |
| Total, all-cause mortality | Cohort 3: Stannsoporfin 4.5 mg/kg | 0 | 8 |
| Total, all-cause mortality | Placebo Control | 0 | 15 |
| Total, other adverse events | Cohort 1: Stannsoporfin 1.5 mg/kg | 8 | 17 |
| Total, other adverse events | Cohort 2: Stannsoporfin 3.0 mg/kg | 10 | 18 |
| Total, other adverse events | Cohort 3: Stannsoporfin 4.5 mg/kg | 3 | 8 |
| Total, other adverse events | Placebo Control | 5 | 15 |
| Total, serious adverse events | Cohort 1: Stannsoporfin 1.5 mg/kg | 0 | 17 |
| Total, serious adverse events | Cohort 2: Stannsoporfin 3.0 mg/kg | 1 | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00850993
GET https://conductscience.org/api/trials/v1/NCT00850993/flow?page=2