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NCT00001100 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.
A Phase 3 study of Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT00001100: Completed Phase 3 study of Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001100 is a Phase 3 study of Cytomegalovirus Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 130 participants, below the 197-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (34% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001100, a Phase 3 study of Cytomegalovirus Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the benefits and safety of the antiviral drug ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body, resulting in death in 10-30% of babies with symptoms of CMV. It can cause severe brain damage in a large percentage of surviving babies. Children in this study have a CMV infection of the central nervous system (CNS).
Conditions Studied
Interventions
- DRUG ganciclovir
Study Locations (1)
Alabama
- NIAID/DMID/CASG Central Unit - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
What the finished NCT00001100 record still lists
NCT00001100 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 197-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 1 intervention - of which ganciclovir is the first listed.
NCT00001100 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT00001100 about?
NCT00001100 is a clinical study titled "A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.". The purpose of this study is to evaluate the benefits and safety of the antiviral drug ganciclovir (DHPG) given intravenously to treat newborn infants who are born infected with cytomegalovirus (CMV). CMV is a herpes virus that can infect most organs of the body, resulting in death in 10-30% of babi...
What is the current status of trial NCT00001100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. Estimated completion is 2005-11.
What conditions does trial NCT00001100 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections.
What interventions are being tested in trial NCT00001100?
The interventions under investigation include: ganciclovir (DRUG).
Who is sponsoring clinical trial NCT00001100?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001100 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cytomegalovirus Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001100's enrollment target sits among peer trials
130 6th of 24 higher than 19 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cytomegalovirus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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