Follow up Study of Patients Having Participated in Clinical Trial 64,185-204 (JASMINE_205)

A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Drug: Placebo; Drug: Stannsoporfin

Detailed Description

Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments

• Study Type: Observational
• Enrollment (Actual): 68

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Placebo; Participants received placebo during the earlier study	Drug: Placebo; Matching placebo administered by IM injection; Other Names: Matching Placebo
Stannsoporfin 3.0 mg/kg; Participants received Stannsoporfin 3.0 mg/kg during the earlier study	Drug: Stannsoporfin; Stannsoporfin administered by intramuscular (IM) injection; Other Names: Experimental product
Stannsoporfin 4.5 mg/kg; Participants received Stannsoporfin 4.5 mg/kg during the earlier study	Drug: Stannsoporfin; Stannsoporfin administered by intramuscular (IM) injection; Other Names: Experimental product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reported adverse events (AEs)	48-52 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing assessments	Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded	48 - 52 month
Developmental assessments	The Mullen Scales of Early Learning examination has been selected for its standardized measurement of developmental skills in multiple domains (gross motor, visual reception, fine motor, expressive language, and receptive language). Testing will be done at visits 1 and 2 by a healthcare individual trained to administer the test. The Mullen raw scores, T-scores, and age equivalents will be recorded.	48 - 52 month

Collaborators and Investigators

• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
• Investigators: Study Chair: Global Clinical Leader, MD, InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2013
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: stannsoporfin
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tin mesoporphyrin
• Other Study ID Numbers: 64,185-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO