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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 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.

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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

FieldValue
Enrollment Target 130 participants
Est. Completion 2005-11
Phase Phase 3

What the Registry Record Tells You About NCT00001100

The ClinicalTrials.gov registry entry for NCT00001100 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (34% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.