CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 569 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01350648
NCT01350648N/ACompleted

The Natural History of Liver Disease in a Cohort of Participants With Hepatitis B and/or Hepatitis C With or Without HIV Infection

National Institutes of Health Clinical Center (CC)·observational·Posted May 10, 2011·Updated Oct 1, 2024

In Brief

An observational study for Hepatitis B and 2 related conditions. Completed, enrolled 569 participants across 2 sites.

Detailed Summary

Background: \- Hepatitis B and hepatitis C can cause liver damage. They can also cause serious illness, including liver cancer, and even death. This study will follow people who have hepatitis B or hepatitis C. The purpose is to understand more about how these viruses affect the immune system over the long term (up to 10 years). The study will also compare how these viruses affect people who do and do not have HIV, the virus that causes AIDS. Objectives: * To do a long-term study of hepatitis B and hepatitis C infection. * To study the effects of hepatitis B and hepatitis C infection in people do and do not have HIV. Eligibility: \- People at least 18 years of age who have hepatitis B or hepatitis C and have a regular doctor for their medical care. Design: * Participants will be screened with a physical exam and medical history. Those who do not have a regular doctor to provide medical care during the study will not be able to take part. * Participants will have yearly visits with study researchers for up to 10 years. These tests will be done at each visit. * Medical history and physical exam. * Questionnaire (optional) on emotions, sexual behaviors, use of alcohol and drugs, and quality of life. * Blood and urine tests, including HIV testing. * Tissue sample collections for those who have had a liver or other tissue biopsy. * Participants may leave the study at any time. They will receive the standard of care from their regular doctor throughout the study.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2011
Enrollment StartAug 23, 2011
Primary CompletionMar 4, 2022
Study CompletionMar 17, 2022
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 15.1 years ago