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Long-term Follow-up of HALT-C Sustained Virological Responders

NCT00825877 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2019-12-17

No results posted yet for this study

Summary

The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) trial is a multicenter clinical trial conducted to assess the effects of long-term antiviral drug therapy on the progression of liver disease in patients who have advanced chronic hepatitis C and have not responded to prior therapies. Chronic hepatitis C is a long-lasting viral infection affecting the liver that may lead to permanent liver damage and cirrhosis (replacement of healthy liver cells by scar tissue). If left untreated, a proportion of patients with chronic hepatitis C will be at risk for complications of liver disease. The drug therapy in the HALT-C trial was designed to clear the hepatitis C virus from the patient s system in order to prevent or mitigate these potential complications. The purpose of this research is to determine if patients with chronic hepatitis C who experienced clearance of hepatitis C virus (known as a sustained virologic response, or SVR) during the HALT-C trial have developed any complications of their liver disease.

This study will include 180 subjects who participated in the initial phase of the HALT-C trial and experienced an SVR. The participants will visit the National Institutes of Health for an in-person study visit.

During the visit, patients will have blood drawn for lab tests to monitor the progress of their liver disease, and may be asked to undergo an ultrasound examination of the liver to detect any abnormalities that may be attributed to liver cancer. Patients will also answer questions about their medical history particularly any outcomes or events related to their hepatitis C that have occurred since the HALT-C trial and may be asked to sign a release of information to allow researchers to obtain medical records from other clinics or physicians where they have received treatment.

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Conditions

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Marc G Ghany, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-15
Completion
2012-06-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00825877 on ClinicalTrials.gov