Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).
No interventions were administered during this follow-up study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Stannsoporfin 1.5 mg/kg | Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
| |
| Cohort 2: Stannsoporfin 3.0 mg/kg | Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
| |
| Cohort 3: Stannsoporfin 4.5 mg/kg | Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
| |
| Cohort 4: Placebo Control | Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stannsoporfin | Drug | No intervention was administered during this observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | within 52 months |
Not provided
Not provided
Inclusion Criteria:
Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup
Exclusion Criteria:
Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent
Not provided
Not provided
Babies who participated in protocol 64,185-202 (NCT00850993)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Leader | Mallinckrodt | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007565 | Jaundice |
| D051556 | Hyperbilirubinemia, Neonatal |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C055421 | tin mesoporphyrin |
| D012965 | Sodium Chloride |
| D010789 | Phototherapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Control | Drug | No intervention was administered during this observational study |
|
|
| Phototherapy (as needed) | Other | No intervention was administered during this observational study |
|
|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017670 |
| Sodium Compounds |
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |