Study Stopped
Study stopped for business reasons and not for any safety reasons.
Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
1 other identifier
observational
55
0 countries
N/A
Brief Summary
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2006
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2016
CompletedOctober 15, 2019
February 1, 2016
9.9 years
February 10, 2016
October 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
NEUROLOGICAL EXAMINATION; Child Behavior Check List
Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients
10 years
Study Arms (2)
0.75 mg/kg Previous exposure to stannsoporfin
Previous exposure 0.75 mg/kg
1.5 mg/kg Previous exposure to stannsoporfin
Previous exposure 1.5 mg/kg
Interventions
No intervention in this protocol
Eligibility Criteria
All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
You may qualify if:
- All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nancy Ruiz, MD
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 18, 2016
Study Start
July 1, 2006
Primary Completion
May 10, 2016
Study Completion
May 10, 2016
Last Updated
October 15, 2019
Record last verified: 2016-02