Long-term Follow-up of HALT-C Sustained Virological Responders
|First Submitted Date||January 17, 2009|
|First Posted Date||January 21, 2009|
|Last Update Posted Date||October 6, 2017|
|Start Date||January 15, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00825877 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Long-term Follow-up of HALT-C Sustained Virological Responders|
|Official Title||Long-Term Follow-Up of HALT-C Sustained Virologic Responders|
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.
|Detailed Description||Subjects who have achieved a sustained virologic response during their participation in the multicentered HALT-C clinical trial for treatment of chronic hepatitis C are being invited to return for a single clinic visit to assess whether any decompensation events (e.g. ascites, varicela hemorrhage, hepatic encephalopathy) or hepatocellular cancer has occurred. Subjects able and willing to return to the NIH will undergo standard clinical examinations, questionnaires and an ultrasound examination of the liver, to assess the status of their hepatitis C. Data will be pooled from all of the 10 clinical centers, analyzed and compared to an age and gender matched control group of nonresponder subjects who participated in the HALT-C Trial. A data coordinating center (New England Research Institutes) will conduct the data analysis. This will be a descriptive natural history study.|
|Study Design||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Estimated Completion Date||June 29, 2012|
|Primary Completion Date||Not Provided|
Patients who developed a virological response at week 20 of the HALT-C study.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||090067
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 29, 2012|