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Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment (HALT-C)

Primary Purpose

Chronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Peginterferon alfa-2a + Ribavirin
Peginterferon alfa-2a
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Hepatitis c focused on measuring liver disease, hepatitis c virus, antiviral agent, cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age at entry at least 18 years. Positive for Hepatitis C. Previous treatment with any interferon or interferon and ribavirin for at least 3 months. Documented non-response to treatment with interferon. A liver biopsy demonstrating significant liver scarring. Exclusion Criteria: No other liver disease. No unstable major medical diseases or conditions. No major complications of cirrhosis. No recent abuse of alcohol or illicit drugs.

Sites / Locations

  • University of California-Irvine/VA Medical Center-Long Beach
  • USC School of Medicine
  • UCHSC (University of Colorado)
  • University of Connecticut Health Center
  • Lds, Niddk, Nih
  • Massachusetts General Hospital
  • UMass Memorial HealthCare, University Campus
  • University of Michigan
  • Saint Louis University
  • University of Texas Southwestern - Dallas
  • Medical College of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Peg-interferon alfa-2a 90 mcg/week

Standard of care followup

Outcomes

Primary Outcome Measures

Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points
Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study
Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies
For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)
Death From Any Cause
Development of Hepatocellular Carcinoma (HCC)
A diagnosis of development of hepatocellular carcinoma (HCC) was based on either Histology showing HCC (from a biopsy, surgery, or autopsy) or A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml.
Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits
Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)
Variceal Hemorrhage
A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified
Ascites
Any abdominal fluid which is: Mild, moderate or marked on ultrasound; or Progressive on serial physical examinations; or Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is "mild" ("barely detectable") on physical examination requires ultrasound confirmation that is "mild", "moderate" or "marked" ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition.
Spontaneous Bacterial Peritonitis
Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.
Hepatic Encephalopathy
Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).

Secondary Outcome Measures

Serious Adverse Events
A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following: Death Is life threatening (risk of death at the time of the event) Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Congenital abnormality or birth defect Trial outcomes (except death) were not considered serious adverse events.
Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.
Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)
Presumed Hepatocellular Carcinoma (HCC)
Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if: A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC. AFP> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC. A progressively enlarging hepatic lesion starting as a new defect resulting in patient death. A new hepatic defect with at least 1 characteristic scan and: Increase in size over time or Increasing AFP rising to a level of >200 ng/ml
SF-36 Vitality Summary Score
Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
SF-36 Physical Function Summary Score
Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
SF-36 Mental Health Summary Score
Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.

Full Information

First Posted
August 8, 2000
Last Updated
April 29, 2020
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Minority Health and Health Disparities (NIMHD), National Cancer Institute (NCI), Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00006164
Brief Title
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
Acronym
HALT-C
Official Title
Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2000 (Actual)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Minority Health and Health Disparities (NIMHD), National Cancer Institute (NCI), Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months. Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits. The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial. The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis
Keywords
liver disease, hepatitis c virus, antiviral agent, cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Peg-interferon alfa-2a 90 mcg/week
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard of care followup
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a + Ribavirin
Other Intervention Name(s)
Pegasys (Hoffman-La Roche), Copegus (Hoffman-La Roche)
Intervention Description
Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight <75 kg, >75 kg) daily in two divided doses for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys (Hoffman-La Roche)
Intervention Description
90 mcg/week injection, for 3.5 years
Primary Outcome Measure Information:
Title
Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points
Description
Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study
Time Frame
1400 days (3.85 years) post randomization
Title
Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies
Description
For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)
Time Frame
1400 days (3.85 years) post randomization
Title
Death From Any Cause
Time Frame
1400 days (3.85 years) post randomization
Title
Development of Hepatocellular Carcinoma (HCC)
Description
A diagnosis of development of hepatocellular carcinoma (HCC) was based on either Histology showing HCC (from a biopsy, surgery, or autopsy) or A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml.
Time Frame
1400 days (3.85 years) post randomization
Title
Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits
Description
Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)
Time Frame
1400 days (3.85 years) post randomization
Title
Variceal Hemorrhage
Description
A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified
Time Frame
1400 days (3.85 years) post randomization
Title
Ascites
Description
Any abdominal fluid which is: Mild, moderate or marked on ultrasound; or Progressive on serial physical examinations; or Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is "mild" ("barely detectable") on physical examination requires ultrasound confirmation that is "mild", "moderate" or "marked" ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition.
Time Frame
1400 days (3.85 years) post randomization
Title
Spontaneous Bacterial Peritonitis
Description
Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.
Time Frame
1400 days (3.85 years) post randomization
Title
Hepatic Encephalopathy
Description
Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).
Time Frame
1400 days (3.85 years) post randomization
Secondary Outcome Measure Information:
Title
Serious Adverse Events
Description
A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following: Death Is life threatening (risk of death at the time of the event) Requires in-patient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Congenital abnormality or birth defect Trial outcomes (except death) were not considered serious adverse events.
Time Frame
1400 days (3.85 years) post randomization
Title
Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.
Description
Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)
Time Frame
1400 days (3.85 years) post randomization
Title
Presumed Hepatocellular Carcinoma (HCC)
Description
Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if: A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC. AFP> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC. A progressively enlarging hepatic lesion starting as a new defect resulting in patient death. A new hepatic defect with at least 1 characteristic scan and: Increase in size over time or Increasing AFP rising to a level of >200 ng/ml
Time Frame
1400 days (3.85 years) post randomization
Title
SF-36 Vitality Summary Score
Description
Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
Time Frame
0.5, 1.5, 2.5, and 3.5 years after randomization
Title
SF-36 Physical Function Summary Score
Description
Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
Time Frame
0.5, 1.5, 2.5, and 3.5 years after randomization
Title
SF-36 Mental Health Summary Score
Description
Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
Time Frame
0.5, 1.5, 2.5, and 3.5 years after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age at entry at least 18 years. Positive for Hepatitis C. Previous treatment with any interferon or interferon and ribavirin for at least 3 months. Documented non-response to treatment with interferon. A liver biopsy demonstrating significant liver scarring. Exclusion Criteria: No other liver disease. No unstable major medical diseases or conditions. No major complications of cirrhosis. No recent abuse of alcohol or illicit drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory T. Everson, M.D.
Organizational Affiliation
UCHSC (University of Colorado)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian M. Di Bisceglie, M.D.
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William M. Lee, M.D.
Organizational Affiliation
University of Texas, Southwestern Medical Center at Dallas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Ghany, M.D.
Organizational Affiliation
LDS, NIDDK, NIH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jules L. Dienstag, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitchell Shiffman, M.D.
Organizational Affiliation
Medical College of Virginia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Lok, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tim Morgan, M.D.
Organizational Affiliation
University of California-Irvine/VA Medical Center-Long Beach
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Lindsay, M.D., M.M.M.
Organizational Affiliation
USC School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gyongyi Szabo, M.D., Ph.D.
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California-Irvine/VA Medical Center-Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
USC School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCHSC (University of Colorado)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Lds, Niddk, Nih
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1800
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
UMass Memorial HealthCare, University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Texas Southwestern - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9195
Country
United States
Facility Name
Medical College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0341
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/halt-c/?query=HALT-C
IPD Sharing URL
https://repository.niddk.nih.gov/studies/halt-c/?query=HALT-C
Citations:
PubMed Identifier
15465617
Citation
Lee WM, Dienstag JL, Lindsay KL, Lok AS, Bonkovsky HL, Shiffman ML, Everson GT, Di Bisceglie AM, Morgan TR, Ghany MG, Morishima C, Wright EC, Everhart JE; HALT-C Trial Group. Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders. Control Clin Trials. 2004 Oct;25(5):472-92. doi: 10.1016/j.cct.2004.08.003.
Results Reference
background
PubMed Identifier
19052125
Citation
Di Bisceglie AM, Shiffman ML, Everson GT, Lindsay KL, Everhart JE, Wright EC, Lee WM, Lok AS, Bonkovsky HL, Morgan TR, Ghany MG, Morishima C, Snow KK, Dienstag JL; HALT-C Trial Investigators. Prolonged therapy of advanced chronic hepatitis C with low-dose peginterferon. N Engl J Med. 2008 Dec 4;359(23):2429-41. doi: 10.1056/NEJMoa0707615.
Results Reference
result
PubMed Identifier
25079603
Citation
Donlin MJ, Lomonosova E, Kiss A, Cheng X, Cao F, Curto TM, Di Bisceglie A, Tavis JE. HCV genome-wide genetic analyses in context of disease progression and hepatocellular carcinoma. PLoS One. 2014 Jul 31;9(7):e103748. doi: 10.1371/journal.pone.0103748. eCollection 2014.
Results Reference
derived
PubMed Identifier
24886378
Citation
Snow KK, Bell MC, Stoddard AM, Curto TM, Wright EC, Dienstag JL. Processes to manage analyses and publications in a phase III multicenter randomized clinical trial. Trials. 2014 May 7;15:159. doi: 10.1186/1745-6215-15-159.
Results Reference
derived
PubMed Identifier
22688849
Citation
Morishima C, Shiffman ML, Dienstag JL, Lindsay KL, Szabo G, Everson GT, Lok AS, Di Bisceglie AM, Ghany MG, Naishadham D, Morgan TR, Wright EC; HALT-C Trial Group. Reduction in Hepatic Inflammation Is Associated With Less Fibrosis Progression and Fewer Clinical Outcomes in Advanced Hepatitis C. Am J Gastroenterol. 2012 Sep;107(9):1388-98. doi: 10.1038/ajg.2012.137. Epub 2012 Jun 12.
Results Reference
derived
PubMed Identifier
22571902
Citation
Morishima C, Di Bisceglie AM, Rothman AL, Bonkovsky HL, Lindsay KL, Lee WM, Koziel MJ, Fontana RJ, Kim HY, Wright EC; HALT-C Trial Group. Antigen-specific T lymphocyte proliferation decreases over time in advanced chronic hepatitis C. J Viral Hepat. 2012 Jun;19(6):404-13. doi: 10.1111/j.1365-2893.2011.01562.x. Epub 2011 Dec 16.
Results Reference
derived
PubMed Identifier
22103814
Citation
Fontana RJ, Litman HJ, Dienstag JL, Bonkovsky HL, Su G, Sterling RK, Lok AS; HALT-C Trial Group. YKL-40 genetic polymorphisms and the risk of liver disease progression in patients with advanced fibrosis due to chronic hepatitis C. Liver Int. 2012 Apr;32(4):665-74. doi: 10.1111/j.1478-3231.2011.02686.x. Epub 2011 Nov 22.
Results Reference
derived
PubMed Identifier
22030902
Citation
Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1.
Results Reference
derived
PubMed Identifier
21931376
Citation
Sterling RK, Wright EC, Morgan TR, Seeff LB, Hoefs JC, Di Bisceglie AM, Dienstag JL, Lok AS. Frequency of elevated hepatocellular carcinoma (HCC) biomarkers in patients with advanced hepatitis C. Am J Gastroenterol. 2012 Jan;107(1):64-74. doi: 10.1038/ajg.2011.312. Epub 2011 Sep 20.
Results Reference
derived
PubMed Identifier
21829595
Citation
O'Bryan JM, Potts JA, Bonkovsky HL, Mathew A, Rothman AL; HALT-C Trial Group. Extended interferon-alpha therapy accelerates telomere length loss in human peripheral blood T lymphocytes. PLoS One. 2011;6(8):e20922. doi: 10.1371/journal.pone.0020922. Epub 2011 Aug 4.
Results Reference
derived
PubMed Identifier
21782771
Citation
Rakoski MO, Brown MB, Fontana RJ, Bonkovsky HL, Brunt EM, Goodman ZD, Lok AS, Omary MB; HALT-C Trial Group. Mallory-Denk bodies are associated with outcomes and histologic features in patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2011 Oct;9(10):902-909.e1. doi: 10.1016/j.cgh.2011.07.006. Epub 2011 Jul 23.
Results Reference
derived
PubMed Identifier
21760886
Citation
O'Brien TR, Everhart JE, Morgan TR, Lok AS, Chung RT, Shao Y, Shiffman ML, Dotrang M, Sninsky JJ, Bonkovsky HL, Pfeiffer RM; HALT-C Trial Group. An IL28B genotype-based clinical prediction model for treatment of chronic hepatitis C. PLoS One. 2011;6(7):e20904. doi: 10.1371/journal.pone.0020904. Epub 2011 Jul 8.
Results Reference
derived
PubMed Identifier
21699796
Citation
Hoefs JC, Shiffman ML, Goodman ZD, Kleiner DE, Dienstag JL, Stoddard AM; HALT-C Trial Group. Rate of progression of hepatic fibrosis in patients with chronic hepatitis C: results from the HALT-C Trial. Gastroenterology. 2011 Sep;141(3):900-908.e1-2. doi: 10.1053/j.gastro.2011.06.007. Epub 2011 Jun 12.
Results Reference
derived
PubMed Identifier
21520194
Citation
Dienstag JL, Ghany MG, Morgan TR, Di Bisceglie AM, Bonkovsky HL, Kim HY, Seeff LB, Szabo G, Wright EC, Sterling RK, Everson GT, Lindsay KL, Lee WM, Lok AS, Morishima C, Stoddard AM, Everhart JE; HALT-C Trial Group. A prospective study of the rate of progression in compensated, histologically advanced chronic hepatitis C. Hepatology. 2011 Aug;54(2):396-405. doi: 10.1002/hep.24370. Epub 2011 Jun 23.
Results Reference
derived
PubMed Identifier
21376050
Citation
Freedman ND, Curto TM, Lindsay KL, Wright EC, Sinha R, Everhart JE; HALT-C TRIAL GROUP. Coffee consumption is associated with response to peginterferon and ribavirin therapy in patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1961-9. doi: 10.1053/j.gastro.2011.02.061. Epub 2011 Mar 2.
Results Reference
derived
PubMed Identifier
21374690
Citation
Lok AS, Everhart JE, Di Bisceglie AM, Kim HY, Hussain M, Morgan TR; HALT-C Trial Group. Occult and previous hepatitis B virus infection are not associated with hepatocellular carcinoma in United States patients with chronic hepatitis C. Hepatology. 2011 Aug;54(2):434-42. doi: 10.1002/hep.24257.
Results Reference
derived
PubMed Identifier
21335007
Citation
Lambrecht RW, Sterling RK, Naishadham D, Stoddard AM, Rogers T, Morishima C, Morgan TR, Bonkovsky HL; HALT-C Trial Group. Iron levels in hepatocytes and portal tract cells predict progression and outcomes of patients with advanced chronic hepatitis C. Gastroenterology. 2011 May;140(5):1490-500.e3. doi: 10.1053/j.gastro.2011.01.053. Epub 2011 Feb 15.
Results Reference
derived
PubMed Identifier
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Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment

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