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NCT01350648 · ClinicalTrials.gov registry record

Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection

A clinical trial of Hepatitis C and Hepatitis B, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
569
Enrollment target
2
Study locations

NCT01350648 is a study of Hepatitis C and Hepatitis B that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 569 participants, below the 1,885-participant average among 106 other Hepatitis C trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01350648, a study of Hepatitis C and Hepatitis B, has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
569 participants
Enrollment target
2
Study locations

Study 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 Locations (2)

District of Columbia

  • VA Medical Center, Washington D.C. - Washington D.C.

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 569 participants
Start Date 2011-08-23
Est. Completion 2022-03-17

What the Registry Record Tells You About NCT01350648

The ClinicalTrials.gov registry entry for NCT01350648 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 569 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,885-participant average among 106 other Hepatitis C trials with a reported enrollment target (70% lower). The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Hepatitis C appearing as the primary indexed condition, and to 0 interventions.

NCT01350648 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.

Frequently Asked Questions

What is clinical trial NCT01350648 about?

NCT01350648 is a clinical study titled "Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection". 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 ...

What is the current status of trial NCT01350648?

This trial is currently completed. The enrollment target is 569 participants. The study started on 2011-08-23. Estimated completion is 2022-03-17.

What conditions does trial NCT01350648 study?

This clinical trial studies the following conditions: Hepatitis C, Hepatitis B, HIV-HCV Co-Infection.

Who is sponsoring clinical trial NCT01350648?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01350648 being conducted?

This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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