- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00031421
Neonatal CMV-Ganciclovir Follow-up Study
A Follow-up Assessment of Subjects Who Received Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) During the Phase I/II Study to Evaluate the Safety and Efficacy of Ganciclovir Treatment for Congenital Cytomegalovirus (CMV) Infections
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama At Birmingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Children who received ganciclovir during the earlier study ("Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections), and if the parent or legal guardian signs an informed consent and the child signs an assent (where appropriate).
Exclusion Criteria:
Any individuals not previously enrolled in the CASG protocol titled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections"
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
16 received ganciclovir at 8 mg/kg/day in the previous study.
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2
31 received ganciclovir at 12 mg/kg/day in the previous study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sexual Development.
Time Frame: Analysis.
|
Analysis.
|
Pubertal Status.
Time Frame: Analysis.
|
Analysis.
|
Cancer Incidence.
Time Frame: Analysis.
|
Analysis.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-489
- N01AI30025C
- CASG 108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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