Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-Term Study of Liver Disease in People With Hepatitis B and/or Hepatitis C With or Without HIV Infection
NCT01350648 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 569 participants |
| Start Date | 2011-08-23 |
| Est. Completion | 2022-03-17 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01350648
The ClinicalTrials.gov registry entry for NCT01350648 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 569 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 209 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Hepatitis C appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01350648 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01350648?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 209 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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