Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment

NCT00006164 | Completed Phase 3 Results DMC FDA Drug

• 12 other identifiers: HALT CN01-DK-9-2328N01-DK-9-2323N01-DK-9-2324N01-DK-9-2325N01-DK-9-2326N01-DK-9-2321N01-DK-9-2327N01-DK-9-2319N01-DK-9-2318N01-DK-9-2320N01-DK-9-2322
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 11

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.

Conditions

Chronic Hepatitis c; Cirrhosis, Liver; Fibrosis, Liver; Hepatic Cirrhosis

Keywords

liver disease; hepatitis c virus; antiviral agent; cirrhosis

Outcome Measures

Primary Outcomes (9)

• 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

  1400 days (3.85 years) post randomization

• 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)

  1400 days (3.85 years) post randomization

• Death From Any Cause

  1400 days (3.85 years) post randomization

• Development of Hepatocellular Carcinoma (HCC)

  A diagnosis of development of hepatocellular carcinoma (HCC) was based on either 1. Histology showing HCC (from a biopsy, surgery, or autopsy) or 2. A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to \> 1,000 ng/ml.

  1400 days (3.85 years) post randomization

• 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)

  1400 days (3.85 years) post randomization

• 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

  1400 days (3.85 years) post randomization

• Ascites

  Any abdominal fluid which is: 1. Mild, moderate or marked on ultrasound; or 2. Progressive on serial physical examinations; or 3. 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.

  1400 days (3.85 years) post randomization

• 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.

  1400 days (3.85 years) post randomization

• 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).

  1400 days (3.85 years) post randomization

Secondary Outcomes (6)

• Serious Adverse Events

  1400 days (3.85 years) post randomization

• Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.

  1400 days (3.85 years) post randomization

• Presumed Hepatocellular Carcinoma (HCC)

  1400 days (3.85 years) post randomization

• SF-36 Vitality Summary Score

  0.5, 1.5, 2.5, and 3.5 years after randomization

• SF-36 Physical Function Summary Score

  0.5, 1.5, 2.5, and 3.5 years after randomization

Study Arms (2)

1

EXPERIMENTAL

Peg-interferon alfa-2a 90 mcg/week

Drug: Peginterferon alfa-2a + Ribavirin; Drug: Peginterferon alfa-2a

2

ACTIVE COMPARATOR

Standard of care followup

Drug: Peginterferon alfa-2a + Ribavirin

Interventions

Peginterferon alfa-2a + Ribavirin DRUG

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

Also known as: Pegasys (Hoffman-La Roche), Copegus (Hoffman-La Roche)

1; 2

Peginterferon alfa-2a DRUG

90 mcg/week injection, for 3.5 years

Also known as: Pegasys (Hoffman-La Roche)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No other liver disease.
• No unstable major medical diseases or conditions.
• No major complications of cirrhosis.
• No recent abuse of alcohol or illicit drugs.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• National Cancer Institute (NCI): collaborator
• Hoffmann-La Roche: collaborator

Study Sites (11)

University of California-Irvine/VA Medical Center-Long Beach

Long Beach, California, 90822, United States

Location

USC School of Medicine

Los Angeles, California, 90033, United States

Location

UCHSC (University of Colorado)

Denver, Colorado, 80262, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Lds, Niddk, Nih

Bethesda, Maryland, 20892-1800, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMass Memorial HealthCare, University Campus

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

University of Texas Southwestern - Dallas

Dallas, Texas, 75390-9195, United States

Location

Medical College of Virginia

Richmond, Virginia, 23298-0341, United States

Location

Related Publications (35)

• 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.

  PMID: 15465617 BACKGROUND

• 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.

  PMID: 19052125 RESULT

• Yu L, Paski SC, Dodge J, Bambha K, Biggins SW, Ioannou GN. Effect of dietary branched chain amino acids on liver related mortality: Results from a large cohort of North American patients with advanced HCV infection. PLoS One. 2023 Apr 25;18(4):e0284739. doi: 10.1371/journal.pone.0284739. eCollection 2023.

  PMID: 37098004 DERIVED

• 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.

  PMID: 25079603 DERIVED

• 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.

  PMID: 24886378 DERIVED

• 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.

  PMID: 22688849 DERIVED

• 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.

  PMID: 22571902 DERIVED

• 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.

  PMID: 22103814 DERIVED

• 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.

  PMID: 22030902 DERIVED

• 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.

  PMID: 21931376 DERIVED

• 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.

  PMID: 21829595 DERIVED

• 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.

  PMID: 21782771 DERIVED

• 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.

  PMID: 21760886 DERIVED

• 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.

  PMID: 21699796 DERIVED

• 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.

  PMID: 21520194 DERIVED

• 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.

  PMID: 21376050 DERIVED

• 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.

  PMID: 21374690 DERIVED

• 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.

  PMID: 21335007 DERIVED

• Fontana RJ, Sanyal AJ, Ghany MG, Bonkovsky HL, Morgan TR, Litman HJ, Reid AE, Lee WM, Naishadham D; HALT-C Trial Study Group. Development and progression of portal hypertensive gastropathy in patients with chronic hepatitis C. Am J Gastroenterol. 2011 May;106(5):884-93. doi: 10.1038/ajg.2010.456. Epub 2010 Dec 7.

  PMID: 21139575 DERIVED

• Lok AS, Everhart JE, Wright EC, Di Bisceglie AM, Kim HY, Sterling RK, Everson GT, Lindsay KL, Lee WM, Bonkovsky HL, Dienstag JL, Ghany MG, Morishima C, Morgan TR; HALT-C Trial Group. Maintenance peginterferon therapy and other factors associated with hepatocellular carcinoma in patients with advanced hepatitis C. Gastroenterology. 2011 Mar;140(3):840-9; quiz e12. doi: 10.1053/j.gastro.2010.11.050. Epub 2010 Dec 1.

  PMID: 21129375 DERIVED

• Freedman ND, Curto TM, Morishima C, Seeff LB, Goodman ZD, Wright EC, Sinha R, Everhart JE; HALT-C Trial Group. Silymarin use and liver disease progression in the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis trial. Aliment Pharmacol Ther. 2011 Jan;33(1):127-37. doi: 10.1111/j.1365-2036.2010.04503.x. Epub 2010 Nov 2.

  PMID: 21083592 DERIVED

• Kronfol Z, Litman HJ, Back-Madruga C, Bieliauskas LA, Lindsay KL, Lok AS, Fontana RJ; HALT-C Trial Group. No increase in depression with low-dose maintenance peginterferon in prior non-responders with chronic hepatitis C. J Affect Disord. 2011 Mar;129(1-3):205-12. doi: 10.1016/j.jad.2010.09.010.

  PMID: 20889211 DERIVED

• Fontana RJ, Dienstag JL, Bonkovsky HL, Sterling RK, Naishadham D, Goodman ZD, Lok AS, Wright EC, Su GL; HALT-C Trial Group. Serum fibrosis markers are associated with liver disease progression in non-responder patients with chronic hepatitis C. Gut. 2010 Oct;59(10):1401-9. doi: 10.1136/gut.2010.207423. Epub 2010 Jul 30.

  PMID: 20675691 DERIVED

• Morgan TR, Ghany MG, Kim HY, Snow KK, Shiffman ML, De Santo JL, Lee WM, Di Bisceglie AM, Bonkovsky HL, Dienstag JL, Morishima C, Lindsay KL, Lok AS; HALT-C Trial Group. Outcome of sustained virological responders with histologically advanced chronic hepatitis C. Hepatology. 2010 Sep;52(3):833-44. doi: 10.1002/hep.23744.

  PMID: 20564351 DERIVED

• Seeff LB, Everson GT, Morgan TR, Curto TM, Lee WM, Ghany MG, Shiffman ML, Fontana RJ, Di Bisceglie AM, Bonkovsky HL, Dienstag JL; HALT-C Trial Group. Complication rate of percutaneous liver biopsies among persons with advanced chronic liver disease in the HALT-C trial. Clin Gastroenterol Hepatol. 2010 Oct;8(10):877-83. doi: 10.1016/j.cgh.2010.03.025. Epub 2010 Apr 1.

  PMID: 20362695 DERIVED

• Fontana RJ, Sanyal AJ, Ghany MG, Lee WM, Reid AE, Naishadham D, Everson GT, Kahn JA, Di Bisceglie AM, Szabo G, Morgan TR, Everhart JE; HALT-C Trial Group. Factors that determine the development and progression of gastroesophageal varices in patients with chronic hepatitis C. Gastroenterology. 2010 Jun;138(7):2321-31, 2331.e1-2. doi: 10.1053/j.gastro.2010.02.058. Epub 2010 Mar 6.

  PMID: 20211180 DERIVED

• Snow KK, Bonkovsky HL, Fontana RJ, Kim HY, Sterling RK, Di Bisceglie AM, Morgan TR, Dienstag JL, Ghany MG; HALT-C Trial Group. Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C. Aliment Pharmacol Ther. 2010 Apr;31(7):719-34. doi: 10.1111/j.1365-2036.2010.04235.x. Epub 2010 Jan 12.

  PMID: 20070284 DERIVED

• Lok AS, Sterling RK, Everhart JE, Wright EC, Hoefs JC, Di Bisceglie AM, Morgan TR, Kim HY, Lee WM, Bonkovsky HL, Dienstag JL; HALT-C Trial Group. Des-gamma-carboxy prothrombin and alpha-fetoprotein as biomarkers for the early detection of hepatocellular carcinoma. Gastroenterology. 2010 Feb;138(2):493-502. doi: 10.1053/j.gastro.2009.10.031. Epub 2009 Oct 20.

  PMID: 19852963 DERIVED

• Ghany MG, Lok AS, Everhart JE, Everson GT, Lee WM, Curto TM, Wright EC, Stoddard AM, Sterling RK, Di Bisceglie AM, Bonkovsky HL, Morishima C, Morgan TR, Dienstag JL; HALT-C Trial Group. Predicting clinical and histologic outcomes based on standard laboratory tests in advanced chronic hepatitis C. Gastroenterology. 2010 Jan;138(1):136-46. doi: 10.1053/j.gastro.2009.09.007. Epub 2009 Sep 18.

  PMID: 19766643 DERIVED

• Shiffman ML, Morishima C, Dienstag JL, Lindsay KL, Hoefs JC, Lee WM, Wright EC, Naishadham D, Everson GT, Lok AS, Di Bisceglie AM, Bonkovsky HL, Ghany MG; HALT-C Trial Group. Effect of HCV RNA suppression during peginterferon alfa-2a maintenance therapy on clinical outcomes in the HALT-C trial. Gastroenterology. 2009 Dec;137(6):1986-94. doi: 10.1053/j.gastro.2009.08.067. Epub 2009 Sep 10.

  PMID: 19747918 DERIVED

• Freedman ND, Everhart JE, Lindsay KL, Ghany MG, Curto TM, Shiffman ML, Lee WM, Lok AS, Di Bisceglie AM, Bonkovsky HL, Hoefs JC, Dienstag JL, Morishima C, Abnet CC, Sinha R; HALT-C Trial Group. Coffee intake is associated with lower rates of liver disease progression in chronic hepatitis C. Hepatology. 2009 Nov;50(5):1360-9. doi: 10.1002/hep.23162.

  PMID: 19676128 DERIVED

• Everhart JE, Lok AS, Kim HY, Morgan TR, Lindsay KL, Chung RT, Bonkovsky HL, Ghany MG; HALT-C Trial Group. Weight-related effects on disease progression in the hepatitis C antiviral long-term treatment against cirrhosis trial. Gastroenterology. 2009 Aug;137(2):549-57. doi: 10.1053/j.gastro.2009.05.007. Epub 2009 May 13.

  PMID: 19445938 DERIVED

• Lok AS, Everhart JE, Chung RT, Kim HY, Everson GT, Hoefs JC, Greenson JK, Sterling RK, Lindsay KL, Lee WM, Di Bisceglie AM, Bonkovsky HL, Ghany MG, Morishima C; HALT-C Trial Group. Evolution of hepatic steatosis in patients with advanced hepatitis C: results from the hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial. Hepatology. 2009 Jun;49(6):1828-37. doi: 10.1002/hep.22865.

  PMID: 19291787 DERIVED

• Lok AS, Seeff LB, Morgan TR, di Bisceglie AM, Sterling RK, Curto TM, Everson GT, Lindsay KL, Lee WM, Bonkovsky HL, Dienstag JL, Ghany MG, Morishima C, Goodman ZD; HALT-C Trial Group. Incidence of hepatocellular carcinoma and associated risk factors in hepatitis C-related advanced liver disease. Gastroenterology. 2009 Jan;136(1):138-48. doi: 10.1053/j.gastro.2008.09.014. Epub 2008 Sep 18.

  PMID: 18848939 DERIVED

• Lindsay KL, Morishima C, Wright EC, Dienstag JL, Shiffman ML, Everson GT, Lok AS, Bonkovsky HL, Lee WM, Morgan TR, Ghany MG; HALT-C Trial. Blunted cytopenias and weight loss: new correlates of virologic null response to re-treatment of chronic hepatitis C. Clin Gastroenterol Hepatol. 2008 Feb;6(2):234-41. doi: 10.1016/j.cgh.2007.11.020.

  PMID: 18237873 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Cirrhosis; Liver Diseases; Hepatitis C; Fibrosis

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: James E. Everhart, MD, MPH, Project Officer
• Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

EverhartJ@extra.niddk.nih.gov

301-594-8878

Study Officials

• Gregory T. Everson, M.D.

  UCHSC (University of Colorado)

  PRINCIPAL INVESTIGATOR

• Adrian M. Di Bisceglie, M.D.

  St. Louis University

  PRINCIPAL INVESTIGATOR

• William M. Lee, M.D.

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Marc Ghany, M.D.

  LDS, NIDDK, NIH

  PRINCIPAL INVESTIGATOR

• Jules L. Dienstag, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Mitchell Shiffman, M.D.

  Medical College of Virginia

  PRINCIPAL INVESTIGATOR

• Anna Lok, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Tim Morgan, M.D.

  University of California-Irvine/VA Medical Center-Long Beach

  PRINCIPAL INVESTIGATOR

• Karen Lindsay, M.D., M.M.M.

  USC School of Medicine

  PRINCIPAL INVESTIGATOR

• Gyongyi Szabo, M.D., Ph.D.

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2000
• First Posted: August 9, 2000
• Study Start: June 1, 2000
• Primary Completion: April 1, 2007
• Study Completion: October 1, 2009
• Last Updated: May 12, 2020
• Results First Posted: September 4, 2009

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (11)