Los Angeles, California 90033

  • Hepatic Cirrhosis

Purpose:

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.


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.


Study is Available At:


Original ID:

HALT C


NCT ID:

NCT00006164


Secondary ID:

N01-DK-9-2328


Study Acronym:

HALT-C


Brief Title:

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


Official Title:

Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial (HALT-C)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1050


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gregory T. Everson, M.D.
Principal Investigator
UCHSC (University of Colorado)

Study Dates

Start Date:June 2000
Completion Date:October 2009
Completion Type:Actual
Primary Completion Date:April 2007
Primary Completion Type:Actual
Verification Date:April 2020
Last Changed Date:April 29, 2020
First Received Date:August 8, 2000
First Results Date:June 9, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:SF-36 Mental Health Summary Score
Time Frame:0.5, 1.5, 2.5, and 3.5 years after randomization
Safety Issues:False
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 maxim
Outcome Type:Secondary Outcome
Measure:SF-36 Physical Function Summary Score
Time Frame:0.5, 1.5, 2.5, and 3.5 years after randomization
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:SF-36 Vitality Summary Score
Time Frame:0.5, 1.5, 2.5, and 3.5 years after randomization
Safety Issues:False
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 disabil
Outcome Type:Secondary Outcome
Measure:Presumed Hepatocellular Carcinoma (HCC)
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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 limi
Outcome Type:Secondary Outcome
Measure:Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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)
Outcome Type:Secondary Outcome
Measure:Serious Adverse Events
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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 Re
Outcome Type:Primary Outcome
Measure:Hepatic Encephalopathy
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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).
Outcome Type:Primary Outcome
Measure:Spontaneous Bacterial Peritonitis
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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.
Outcome Type:Primary Outcome
Measure:Ascites
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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 exam
Outcome Type:Primary Outcome
Measure:Variceal Hemorrhage
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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,
Outcome Type:Primary Outcome
Measure:Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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)
Outcome Type:Primary Outcome
Measure:Development of Hepatocellular Carcinoma (HCC)
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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.
Outcome Type:Primary Outcome
Measure:Death From Any Cause
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies
Time Frame:1400 days (3.85 years) post randomization
Safety Issues:False
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 Yea

Study Interventions

Intervention Type:Drug
Name:Peginterferon alfa-2a
Description:90 mcg/week injection, for 3.5 years
Arm Name:1
Other Name:Pegasys (Hoffman-La Roche)
Intervention Type:Drug
Name:Peginterferon alfa-2a + Ribavirin
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
Arm Name:1
Other Name:Pegasys (Hoffman-La Roche)

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Standard of care followup
Study Arm Type:Experimental
Arm Name:1
Description:Peg-interferon alfa-2a 90 mcg/week

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:19052125
Reference Type:Reference
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.
PMID:15465617

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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