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
4 other identifiers
observational
8
1 country
1
Brief Summary
The purpose of this study is to document the developments associated with puberty and determine if any of the children who previously participated in another research study have been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group (CASG) protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections." One of the medications used in this study to treat cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development of gonads (ovaries in females and testes in males) when administered to animals. Children, 9-14 years old, who participated in the previous research study, will participate in this study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following procedures performed: a complete physical examination, a single blood sample collected, an x-ray of the left wrist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2001
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 6, 2002
CompletedFirst Posted
Study publicly available on registry
March 7, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedAugust 12, 2011
July 1, 2008
March 6, 2002
August 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Sexual Development.
Analysis.
Pubertal Status.
Analysis.
Cancer Incidence.
Analysis.
Study Arms (2)
1
16 received ganciclovir at 8 mg/kg/day in the previous study.
2
31 received ganciclovir at 12 mg/kg/day in the previous study.
Eligibility Criteria
Children of both genders that previously enrolled in "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatice Congenital Cytomegalovirus Infections."
You may qualify if:
- 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).
You may not qualify if:
- Any individuals not previously enrolled in the CASG protocol titled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 6, 2002
First Posted
March 7, 2002
Study Start
September 1, 2001
Study Completion
November 1, 2005
Last Updated
August 12, 2011
Record last verified: 2008-07