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NCT00059592 · ClinicalTrials.gov registry record · Phase 1
Valacyclovir in Immunocompromised Children
A Phase 1 study of Shingles and Bone Marrow Transplantation, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT00059592: Completed Phase 1 study of Shingles and Bone Marrow Transplantation, sponsored by Baylor College of Medicine.
NCT00059592 is a Phase 1 study of Shingles and Bone Marrow Transplantation that has completed, run by Baylor College of Medicine. The registered enrollment target is 37 participants, below the 393-participant average among 6 other Shingles trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059592, a Phase 1 study of Shingles and Bone Marrow Transplantation, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Shingles in children with a weakened immune system may spread throughout the body and in some instances may be life-threatening. Acyclovir is a medication that is routinely used to treat immunocompromised children with shingles in order to prevent further spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow transplant patients to prevent reactivation of HSV infection. Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir. Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth. The purpose of this study is to * study the pharmacology of this drug (how the body handles this drug), * determine if oral Valacyclovir can be safely given to children with shingles, and * determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children.
Conditions Studied
Interventions
- DRUG Valacyclovir
Study Locations (2)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 1998-04-07 |
| Est. Completion | 2005-05-05 |
| Phase | Phase 1 |
What the finished NCT00059592 record still lists
NCT00059592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 393-participant average among 6 other Shingles trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Shingles appearing as the primary indexed condition, and to 1 intervention - of which Valacyclovir is the first listed.
NCT00059592 reports a single indexed study location in Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT00059592 about?
NCT00059592 is a clinical study titled "Valacyclovir in Immunocompromised Children". Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Shingles in children ...
What is the current status of trial NCT00059592?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 1998-04-07. Estimated completion is 2005-05-05.
What conditions does trial NCT00059592 study?
This clinical trial studies the following conditions: Shingles, Bone Marrow Transplantation.
What interventions are being tested in trial NCT00059592?
The interventions under investigation include: Valacyclovir (DRUG).
Who is sponsoring clinical trial NCT00059592?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00059592 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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