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Completed

NCT Number: NCT02000830

Follow up Study of Patients Having Participated 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.

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Key information

Conditions

Hyperbilirubinemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 day–52 month

Sex eligibility

All sexes

Study type

Observational

About this study

Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stannsoporfin

Drug

Stannsoporfin administered by intramuscular (IM) injection

Other names: Experimental product

Placebo

Drug

Matching placebo administered by IM injection

Other names: Matching Placebo

Primary outcomes

  1. Reported adverse events (AEs)

    Time frame: 48-52 month

Secondary outcomes

  1. Hearing assessments

    Time frame: 48 - 52 month

    Conventional audiometry will be performed by a qualified specialist. Any findings from a failed conventional audiology examination will be recorded

  2. Developmental assessments

    Time frame: 48 - 52 month

    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.

Sponsors and collaborators

Lead sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Industry

Registry information

Official study title

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

Acronym: JASMINE_205

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2013
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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