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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006164
First Posted: August 9, 2000
Last Update Posted: January 20, 2010
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.
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:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Results First Submitted: June 9, 2009  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Total Total of all reporting groups

Baseline Measures
   Peginterferon Alfa-2a 90 Mcg/Week   Standard of Care Followup   Total 
Overall Participants Analyzed 
[Units: Participants]
 517   533   1050 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   489   511   1000 
>=65 years   28   22   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.1  (7.3)   50.1  (7.0)   50.6  (7.2) 
Gender 
[Units: Participants]
     
Female   155   150   305 
Male   362   383   745 
Region of Enrollment 
[Units: Participants]
     
United States   517   533   1050 


  Outcome Measures
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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:   Events Requiring Dose Reductions (in Both Treatment Groups).   [ Time Frame: 1400 days (3.85 years) post randomization ]
Results not yet reported.   Anticipated Reporting Date:   10/2010  

12.  Secondary:   Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.   [ Time Frame: 1400 days (3.85 years) post randomization ]
Results not yet reported.   Anticipated Reporting Date:   10/2010  

13.  Secondary:   Presumed Hepatocellular Carcinoma (HCC)   [ Time Frame: 1400 days (3.85 years) post randomization ]
Results not yet reported.   Anticipated Reporting Date:   10/2010  

14.  Secondary:   Quality of Life   [ Time Frame: 1400 days (3.85 years) post randomization ]
Results not yet reported.   Anticipated Reporting Date:   10/2010  


  Serious Adverse Events
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Time Frame Within 1400 days (3.83 years) after randomization
Additional Description In the treatment group, 3991 adverse events occurred among 486 patients, as compared with 3129 adverse events among 492 patients in the control group; 330 patients had at least one serious adverse event.

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

Serious Adverse Events
    Peginterferon Alfa-2a 90 Mcg/Week   Standard of Care Followup
Total, Serious Adverse Events     
# participants affected / at risk   175/517 (33.85%)   155/533 (29.08%) 
Blood and lymphatic system disorders     
Anemia †     
# participants affected / at risk   3/517 (0.58%)   5/533 (0.94%) 
Thrombocytopenia or pancytopenia †     
# participants affected / at risk   4/517 (0.77%)   0/533 (0.00%) 
Cardiac disorders     
Atherosclerotic disease †     
# participants affected / at risk   16/517 (3.09%)   9/533 (1.69%) 
Arrhythmia †     
# participants affected / at risk   3/517 (0.58%)   9/533 (1.69%) 
Other cardiovascular or circulatory event †     
# participants affected / at risk   4/517 (0.77%)   5/533 (0.94%) 
Endocrine disorders     
Electrolyte, mineral, or water imbalance †     
# participants affected / at risk   6/517 (1.16%)   7/533 (1.31%) 
Diabetes and its complications †     
# participants affected / at risk   1/517 (0.19%)   2/533 (0.38%) 
Thyroid disease †     
# participants affected / at risk   2/517 (0.39%)   2/533 (0.38%) 
Gastrointestinal disorders     
Nonvariceal gastrointestinal bleeding †     
# participants affected / at risk   4/517 (0.77%)   9/533 (1.69%) 
Hernia or intestinal obstruction †     
# participants affected / at risk   5/517 (0.97%)   3/533 (0.56%) 
Other digestive system event †     
# participants affected / at risk   11/517 (2.13%)   15/533 (2.81%) 
General disorders     
Cardiovascular signs or symptoms † [2]     
# participants affected / at risk   10/517 (1.93%)   6/533 (1.13%) 
Hepatobiliary signs or symptoms † [2]     
# participants affected / at risk   8/517 (1.55%)   6/533 (1.13%) 
Neurologic signs or symptoms † [2]     
# participants affected / at risk   7/517 (1.35%)   6/533 (1.13%) 
Digestive signs or symptoms † [2]     
# participants affected / at risk   4/517 (0.77%)   3/533 (0.56%) 
Other general signs or symptoms † [2]     
# participants affected / at risk   4/517 (0.77%)   8/533 (1.50%) 
Hepatobiliary disorders     
Gallbladder disease †     
# participants affected / at risk   13/517 (2.51%)   15/533 (2.81%) 
Other pancreatic or biliary disorders †     
# participants affected / at risk   7/517 (1.35%)   5/533 (0.94%) 
Liver-disease events other than primary or secondary outcomes † [3]     
# participants affected / at risk   1/517 (0.19%)   1/533 (0.19%) 
Infections and infestations     
Mucocutaneous infection and infectious diseases †     
# participants affected / at risk   9/517 (1.74%)   16/533 (3.00%) 
Respiratory tract infections and infectious diseases †     
# participants affected / at risk   19/517 (3.68%)   11/533 (2.06%) 
Systemic infections and infectious diseases †     
# participants affected / at risk   10/517 (1.93%)   4/533 (0.75%) 
Other infections and infectious diseases †     
# participants affected / at risk   15/517 (2.90%)   19/533 (3.56%) 
Injury, poisoning and procedural complications     
Injury †     
# participants affected / at risk   4/517 (0.77%)   10/533 (1.88%) 
Drug reaction †     
# participants affected / at risk   4/517 (0.77%)   2/533 (0.38%) 
Liver-biopsy complication †     
# participants affected / at risk   8/517 (1.55%)   11/533 (2.06%) 
Musculoskeletal and connective tissue disorders     
Musculoskelatal surgery †     
# participants affected / at risk   25/517 (4.84%)   21/533 (3.94%) 
Arthritis or back pain †     
# participants affected / at risk   9/517 (1.74%)   6/533 (1.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm †     
# participants affected / at risk   8/517 (1.55%)   10/533 (1.88%) 
Benign neoplasm †     
# participants affected / at risk   1/517 (0.19%)   3/533 (0.56%) 
Nervous system disorders     
Cerebral aneurysm, infarct, or stroke †     
# participants affected / at risk   3/517 (0.58%)   4/533 (0.75%) 
Other neurologic event †     
# participants affected / at risk   3/517 (0.58%)   2/533 (0.38%) 
Psychiatric disorders     
Affective disorders or delirium †     
# participants affected / at risk   8/517 (1.55%)   4/533 (0.75%) 
Suicidal ideation or attempt †     
# participants affected / at risk   4/517 (0.77%)   4/533 (0.75%) 
Substance abuse †     
# participants affected / at risk   3/517 (0.58%)   1/533 (0.19%) 
Renal and urinary disorders     
Renal or urinary diseases †     
# participants affected / at risk   11/517 (2.13%)   8/533 (1.50%) 
Reproductive system and breast disorders     
Gynecologic, menstrual, or sexual disorders †     
# participants affected / at risk   2/517 (0.39%)   5/533 (0.94%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory disorders †     
# participants affected / at risk   2/517 (0.39%)   7/533 (1.31%) 
Skin and subcutaneous tissue disorders     
Benign skin and nail disorders †     
# participants affected / at risk   0/517 (0.00%)   2/533 (0.38%) 
Events were collected by systematic assessment
[2] These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
[3] Liver-disease events not related to death or other study-related clinical primary or secondary outcomes of the trial




  Other Adverse Events


  Limitations and Caveats
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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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