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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006164
Recruitment Status : Completed
First Posted : August 9, 2000
Results First Posted : September 4, 2009
Last Update Posted : May 11, 2018
Sponsor:
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
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Chronic Hepatitis c
Cirrhosis, Liver
Fibrosis, Liver
Hepatic Cirrhosis
Interventions: Drug: Peginterferon alfa-2a + Ribavirin
Drug: Peginterferon alfa-2a

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Peginterferon Alfa-2a 90 mcg/Week Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Standard of Care Followup Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment

Participant Flow:   Overall Study
    Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup
STARTED   517   533 
COMPLETED   447 [1]   452 [2] 
NOT COMPLETED   70   81 
Withdrew or lost to follow-up                70                81 
[1] 70 Withdrew or were lost to followup; 158 Discontinued peginterferon but were followed
[2] 81 Withdrew or were lost to followup; 9 took peginterferon outside of protocol



  Baseline Characteristics


  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   Death From Any Cause   [ Time Frame: 1400 days (3.85 years) post randomization ]

4.  Primary:   Development of Hepatocellular Carcinoma (HCC)   [ Time Frame: 1400 days (3.85 years) post randomization ]

5.  Primary:   Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits   [ Time Frame: 1400 days (3.85 years) post randomization ]

6.  Primary:   Variceal Hemorrhage   [ Time Frame: 1400 days (3.85 years) post randomization ]

7.  Primary:   Ascites   [ Time Frame: 1400 days (3.85 years) post randomization ]

8.  Primary:   Spontaneous Bacterial Peritonitis   [ Time Frame: 1400 days (3.85 years) post randomization ]

9.  Primary:   Hepatic Encephalopathy   [ Time Frame: 1400 days (3.85 years) post randomization ]

10.  Secondary:   Serious Adverse Events   [ Time Frame: 1400 days (3.85 years) post randomization ]

11.  Secondary:   Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.   [ Time Frame: 1400 days (3.85 years) post randomization ]

12.  Secondary:   Presumed Hepatocellular Carcinoma (HCC)   [ Time Frame: 1400 days (3.85 years) post randomization ]

13.  Secondary:   SF-36 Vitality Summary Score   [ Time Frame: 0.5, 1.5, 2.5, and 3.5 years after randomization ]

14.  Secondary:   SF-36 Physical Function Summary Score   [ Time Frame: 0.5, 1.5, 2.5, and 3.5 years after randomization ]

15.  Secondary:   SF-36 Mental Health Summary Score   [ Time Frame: 0.5, 1.5, 2.5, and 3.5 years after randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James E. Everhart, MD, MPH, Project Officer
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
phone: 301-594-8878
e-mail: EverhartJ@extra.niddk.nih.gov


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00006164     History of Changes
Obsolete Identifiers: NCT00006139
Other Study ID Numbers: HALT C
N01-DK-9-2328 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2323 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2324 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2325 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2326 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2321 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2327 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2319 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2318 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2320 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2322 ( Other Grant/Funding Number: NIH NIDDK Contract )
First Submitted: August 8, 2000
First Posted: August 9, 2000
Results First Submitted: June 9, 2009
Results First Posted: September 4, 2009
Last Update Posted: May 11, 2018