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NCT05669677 · ClinicalTrials.gov registry record
Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease
A clinical trial of NAFLD and NASH, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 233
- Enrollment target
- 1
- Study location
NCT05669677: Completed study of NAFLD and NASH, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT05669677 is a study of NAFLD and NASH that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 233 participants, above the 156-participant average among 26 other NAFLD trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05669677, a study of NAFLD and NASH, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 233 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especially those with an advanced condition called cirrhosis, do not respond to many vaccines as well as healthy people do. The goal of this natural history study is to find out how well people with chronic liver disease respond to the COVID-19 vaccines. Objective: To learn how chronic liver disease affects the body s immune response to vaccination against COVID-19. Eligibility: People aged 18 years or older with chronic liver disease. They must also be enrolled in protocol 91-DK-0214 or 18-DK-0091. Design: Participants will have 3 visits, each spaced 6 months apart. Each visit will last 2 hours. Participants will have their vital signs recorded. These include age, sex, race, height, and weight. They will give their medical history. At each visit, participants will have blood drawn through a needle inserted into a vein in the arm. The sample drawn at each visit will be from 1 to 8 tablespoons. At each visit, participants will fill out a questionnaire. They will answer questions about whether they have been vaccinated against COVID-19; whether they have had COVID-19; and whether they have been exposed to someone who had COVID-19. The questionnaire will take 10 to 15 minutes. Researchers will also look at results of past blood tests from other research studies.
Primary Outcome
To determine the response to SARS-COV-2 vaccination among patients with chronic liver disease stratified by severity (cirrhosis vs no cirrhosis) and compare to healthy controls
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2025-04-04 |
What the finished NCT05669677 record still lists
NCT05669677 is an observational study that tracks outcomes without assigning an intervention. The registered 233 participants enrollment target is mid-sized for trials with a published cap, above the 156-participant average among 26 other NAFLD trials with a reported enrollment target (49% higher).
The record links to 5 conditions, with NAFLD appearing as the primary indexed condition, and to 0 interventions.
NCT05669677 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05669677 about?
NCT05669677 is a clinical study titled "Study to Determine the Response to COVID-19 Vaccination and Prevalence of COVID-19 in Subjects With Chronic Liver Disease". Background: The COVID-19 global pandemic killed more than 6 million people worldwide. Several vaccines have been developed against the virus that causes this disease. These vaccines are effective at preventing severe symptoms and death from COVID-19. Some people with chronic liver disease, especial...
What is the current status of trial NCT05669677?
This trial is currently completed. The enrollment target is 233 participants. The study started on 2023-03-15. Estimated completion is 2025-04-04.
What conditions does trial NCT05669677 study?
This clinical trial studies the following conditions: NAFLD, NASH, Chronic or Recovered Hepatitis B, Chronic or Recovered Hepatitis C, Chronic or Recovered Hepatitis D.
Who is sponsoring clinical trial NCT05669677?
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 NCT05669677 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05669677's enrollment target sits among peer trials
233 6th of 26 higher than 21 of 26 other NAFLD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NAFLD 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.
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