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NCT00058591 · ClinicalTrials.gov registry record · Phase 1

Treating Severe Chronic Epstein-Barr Virus (EBV) Infection With EBV Specific Cytotoxic T Lymphocytes (CTLs)

A Phase 1 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT00058591: Completed Phase 1 study, sponsored by Baylor College of Medicine.

NCT00058591 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00058591, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available. This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient. The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help the body fight off the SCAEBV infection.

Interventions

  • BIOLOGICAL Intravenous injection of EBV specific CTLS

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2000-01
Est. Completion 2008-12
Phase Phase 1
Baylor College of Medicine

616 total trials

What the finished NCT00058591 record still lists

NCT00058591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which Intravenous injection of EBV specific CTLS is the first listed.

NCT00058591 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00058591 about?

NCT00058591 is a clinical study titled "Treating Severe Chronic Epstein-Barr Virus (EBV) Infection With EBV Specific Cytotoxic T Lymphocytes (CTLs)". Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chron...

What is the current status of trial NCT00058591?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2000-01. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00058591?

The interventions under investigation include: Intravenous injection of EBV specific CTLS (BIOLOGICAL).

Who is sponsoring clinical trial NCT00058591?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00058591's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00058591, the US trial registry maintained by the National Library of Medicine. NCT00058591 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.