Neonatal Hyperbilirubinemia Clinical Trial
Official title:
A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202
Verified date | August 2019 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observational follow-up of participants from earlier interventional trial 64,185-202
(NCT00850993).
No interventions were administered during this follow-up study.
Status | Completed |
Enrollment | 42 |
Est. completion date | November 9, 2015 |
Est. primary completion date | June 23, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | within 52 months |
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