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NCT03520660 · ClinicalTrials.gov registry record · Phase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
A Phase 4 study of Cardiovascular Diseases and Diabetes Mellitus, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Active
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
- 1
- Study location
NCT03520660 is a Phase 4 study of Cardiovascular Diseases and Diabetes Mellitus that is active but no longer recruiting, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 121 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03520660, a Phase 4 study of Cardiovascular Diseases and Diabetes Mellitus, is active but no longer recruiting, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure....
Conditions Studied
Interventions
- DRUG Epclusa
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2018-10-19 |
| Est. Completion | 2032-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03520660
The ClinicalTrials.gov registry entry for NCT03520660 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% 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 3 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Epclusa is the first listed.
NCT03520660 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03520660 about?
NCT03520660 is a clinical study titled "People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents". Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: ...
What is the current status of trial NCT03520660?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2018-10-19. Estimated completion is 2032-12-31.
What conditions does trial NCT03520660 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Diabetes Mellitus, Hepatitis C, Chronic.
What interventions are being tested in trial NCT03520660?
The interventions under investigation include: Epclusa (DRUG).
Who is sponsoring clinical trial NCT03520660?
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 NCT03520660 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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