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NCT02364336 · ClinicalTrials.gov registry record · Phase 2
Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment
A Phase 2 study of Chronic Hepatitis B, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02364336 is a Phase 2 study of Chronic Hepatitis B that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 14 participants, below the 293-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02364336, a Phase 2 study of Chronic Hepatitis B, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,. Researchers think that adding a second antiviral medicine might help. Objective: \- To understand how peginterferon might help treat people with chronic hepatitis B. Also, to see if peginterferon is safe to use with other antiviral medications. Eligibility: \- Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral medicines for hepatitis B for at least 4 years. Design: * Participants will be screened with physical exam and medical history. They will complete health questionnaires about their levels of fatigue and pain. They will have blood and urine tests. They may have an eye exam. * Participants also will have a Fibroscan. A test to measure how stiff your liver is. * Eligible participants will have a liver biopsy. Blood will be drawn. * Participants will be admitted to the NIH Clinical Center. They will be injected with the study drug. Then they will have a second liver biopsy. They will be discharged 24 hours later. * Participants will give themselves study drug injections under the skin weekly for 24 weeks. * Participants will have 5 clinic visits during the 24-week treatment period. Then they will have follow-up visits every 12 weeks for 48 weeks. * During visits, participants may have a physical exam and medical history. They may have blood and urine tests. They may have a Fibroscan and complete questionnaires. At the final visit, they will also have a Fibroscan.
Conditions Studied
Interventions
- DRUG Peginterferon alfa-2a
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-02-14 |
| Est. Completion | 2018-05-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02364336
The ClinicalTrials.gov registry entry for NCT02364336 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 14 other Chronic Hepatitis B trials with a reported enrollment target (95% lower). 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 1 condition, with Chronic Hepatitis B appearing as the primary indexed condition, and to 1 intervention - of which Peginterferon alfa-2a is the first listed.
NCT02364336 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02364336 about?
NCT02364336 is a clinical study titled "Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment". Background: \- Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,. Researchers think that adding a second antiviral medicine might help. Objective: \- To understand how peginterferon might help...
What is the current status of trial NCT02364336?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-02-14. Estimated completion is 2018-05-21.
What conditions does trial NCT02364336 study?
This clinical trial studies the following conditions: Chronic Hepatitis B.
What interventions are being tested in trial NCT02364336?
The interventions under investigation include: Peginterferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT02364336?
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.
Where is trial NCT02364336 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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