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

Hyperbilirubinemia, Neonatal Clinical Trial

— JASMINE_205  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000830
• Other study ID #: 64,185-205
• Status: Completed
• Start date: October 17, 2013
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 52 Months

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

Drug:
• Stannsoporfin
Stannsoporfin administered by intramuscular (IM) injection
• Placebo
Matching placebo administered by IM injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported adverse events (AEs)		48-52 month
Secondary	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
Secondary	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