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

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ClinicalTrials.gov Identifier: NCT02000830
Recruitment Status : Enrolling by invitation
First Posted : December 4, 2013
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

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.

Condition or disease Intervention/treatment
Hyperbilirubinemia, Neonatal Drug: stannsoporofin

Detailed Description:

Outcomes will be based on the following variables:

Reported AEs and SAEs Hearing assessments Developmental assessments


Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204
Actual Study Start Date : October 17, 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Group/Cohort Intervention/treatment
Placebo
stannsoporfin 3.0 mg/kg Drug: stannsoporofin
stannsoporfin 4.5 mg/kg Drug: stannsoporofin



Primary Outcome Measures :
  1. Reported adverse events (AEs) [ Time Frame: 48-52 month ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 52 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who received a single dose of trial medication in clinical trial 64,185-204.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000830


Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Investigators
Study Chair: Simmon Tulloch, MD InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Responsible Party: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT02000830     History of Changes
Other Study ID Numbers: 64,185-205
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company:
stannsoporfin

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action