NCT02000830

Brief Summary

The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 17, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

6.4 years

First QC Date

June 28, 2013

Last Update Submit

January 28, 2021

Conditions

Hyperbilirubinemia, Neonatal

Keywords

stannsoporfin

Outcome Measures

Primary Outcomes (1)

  • Reported adverse events (AEs)

    48-52 month

Secondary Outcomes (2)

  • Hearing assessments

    48 - 52 month

  • Developmental assessments

    48 - 52 month

Study Arms (3)

Placebo

Participants received placebo during the earlier study

Drug: Placebo

Stannsoporfin 3.0 mg/kg

Participants received Stannsoporfin 3.0 mg/kg during the earlier study

Drug: Stannsoporfin

Stannsoporfin 4.5 mg/kg

Participants received Stannsoporfin 4.5 mg/kg during the earlier study

Drug: Stannsoporfin

Interventions

StannsoporfinDRUG

Stannsoporfin administered by intramuscular (IM) injection

Also known as: Experimental product
Stannsoporfin 3.0 mg/kgStannsoporfin 4.5 mg/kg
PlaceboDRUG

Matching placebo administered by IM injection

Also known as: Matching Placebo
Placebo

Eligibility Criteria

Age30 Days - 52 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients who received a single dose of trial medication in clinical trial 64,185-204.

You may qualify if:

  • Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
  • Parents or guardians have given written informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

tin mesoporphyrin

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Leader, MD

    InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

December 4, 2013

Study Start

October 17, 2013

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share