Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031421
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2002-03-06
Brief Title:
Neonatal CMV-Ganciclovir Follow-up Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Follow-up Assessment of Subjects Who Received Ganciclovir Dihydroxypropoxymethyl Guanine DHPG During the Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir Treatment for Congenital Cytomegalovirus CMV Infections
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Ganciclovir has been shown to be carcinogenic teratogenic and gonadal toxic in animal models Mice treated with ganciclovir experienced an increase in the incidence of tumors of the preputial gland males harderian gland males forestomach males and females ovaries females uterus females mammary gland females clitoral gland females vagina females and liver females While the preputial and clitoral glands forestomach and harderian glands of mice do not have human counterparts ganciclovir is considered a potential carcinogen in humans Animal data indicate that administration of ganciclovir causes inhibition of spermatogenesis and subsequent infertility possibly due to inhibition of rapidly dividing cell populations including spermatogonia In the animal models these effects were reversible at lower doses and irreversible at higher doses In both male and female mice ganciclovir has been shown to cause decreased fertility Gonadal toxicity in rats mice and dogs included testicular atrophy in males and more variable ovarian atrophy in females There are no data in humans that demonstrate these effects following treatment with ganciclovir This study seeks to formally establish the overall sexual development cancer incidence and pubertal status of those study subjects who previously received six weeks of ganciclovir as they now approach puberty The original study was performed from 1986 to 1991 and therefore subjects who were enrolled are now nine to fourteen years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01AI30025C | None | None | None |
| CASG 108 | None | None | None |