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Protocol Number:
09-DK-0067
- Title:
Long-Term Follow-Up of HALT-C Sustained Virologic Responders
- Number:
09-DK-0067
- Summary:
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.
- Sponsoring Institute:
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
Yes
- Population Exclusion(s):
Children
- Eligibility Criteria:
INCLUSION CRITERIA:
Patients who developed a virological response at week 20 of the HALT-C study.
EXCLUSION CRITERIA:
None
- Special Instructions:
Currently Not Provided
- Keywords:
-
Hepatitis C
-
Sustained Virological Response
-
HALT-C
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Peginterferon and Ribavirin
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HCV RNA
- Recruitment Keyword(s):
-
None
- Condition(s):
-
Hepatitis C
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Hepatocellular Carcinoma
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Ascites
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Variceal Hemorrhage
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Death
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Institute of Diabetes and Digestive and Kidney Diseases
- Contact(s):
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Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
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Morishima C, Morgan TR, Everhart JE, Wright EC, Shiffman ML, Everson GT, Lindsay KL, Lok AS, Bonkovsky HL, Di Bisceglie AM, Lee WM, Dienstag JL, Ghany MG, Gretch DR; HALT-C Trial Group. HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial. Hepatology. 2006 Aug;44(2):360-7.
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Ikeda K, Saitoh S, Arase Y, Chayama K, Suzuki Y, Kobayashi M, Tsubota A, Nakamura I, Murashima N, Kumada H, Kawanishi M. Effect of interferon therapy on hepatocellular carcinogenesis in patients with chronic hepatitis type C: A long-term observation study of 1,643 patients using statistical bias correction with proportional hazard analysis. Hepatology. 1999 Apr;29(4):1124-30.
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Yoshida H, Shiratori Y, Moriyama M, Arakawa Y, Ide T, Sata M, Inoue O, Yano M, Tanaka M, Fujiyama S, Nishiguchi S, Kuroki T, Imazeki F, Yokosuka O, Kinoyama S, Yamada G, Omata M. Interferon therapy reduces the risk for hepatocellular carcinoma: national surveillance program of cirrhotic and noncirrhotic patients with chronic hepatitis C in Japan. IHIT Study Group. Inhibition of Hepatocarcinogenesis by Interferon Therapy. Ann Intern Med. 1999 Aug 3;131(3):174-81.
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Bethesda, Maryland 20892. Last update: 01/30/2009
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