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NCT01581554 · ClinicalTrials.gov registry record
Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 15
- Enrollment target
NCT01581554 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 15 participants.
The verdict
NCT01581554 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study Summary
Background: \- Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term use. But the drugs have not yet been approved for long-term use because some of them can have serious side effects. However, stopping treatment too soon can make the infection worse and may lead to more serious forms of liver disease. Researchers have not been able to determine a when to stop treatment. They want to study people with chronic hepatitis B infection to find out the best time to stop treatment and prevent the disease from causing further liver damage. Objectives: * To study the safety and effectiveness of withdrawing antiviral treatment for chronic hepatitis B after at least 4 years of treatment. * To determine whether stopping long-term antiviral treatment for chronic hepatitis B makes the infection worse. Eligibility: \- People who are at least 18 years of age; have been taking antiviral drugs to treat chronic hepatitis B for at least 4 years; and are being evaluated to stop treatment. Design: * Those in the study will be screened with a physical exam, medical history, questionnaire, and blood tests. They will remain under the care of their regular doctor during the study. * They will have an abdominal ultrasound to study scarring in the liver, if they have not had one in the past year. * Those without detectable levels of the hepatitis B virus in their blood will stop antiviral treatment. They will have monthly blood tests for the first 6 months to check virus levels, and then every 3 months afterward. * Those whose blood tests show an increase in virus levels will restart antiviral treatment as directed by the study doctors and their personal doctor. * All those in the study will be monitored until the end of the study.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-05-18 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01581554
The ClinicalTrials.gov registry entry for NCT01581554 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01581554 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01581554 about?
NCT01581554 is a clinical study titled "Withdrawal of Therapy After Long-Term Antiviral Treatment for Chronic Hepatitis B". Background: \- Chronic infection with the hepatitis B virus may lead to cirrhosis, liver disease, and cancer of the liver. There is no cure for the infection, but several drugs have been approved to treat it. These drugs can keep the virus levels low. They seem to be safe for short-term use. But th...
What is the current status of trial NCT01581554?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2011-05-18.
Who is sponsoring clinical trial NCT01581554?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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