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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:
Collaborators:
Hoffmann-La Roche
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006164
First received: August 8, 2000
Last updated: January 12, 2010
Last verified: January 2010
Results First Received: June 9, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
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

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  
Number of Participants  
[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   Safety Issue:   Yes

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   Safety Issue:   No

13.  Secondary:   Presumed Hepatocellular Carcinoma (HCC)   [ Time Frame: 1400 days (3.85 years) post randomization ]
Results not yet reported.   Anticipated Reporting Date:   10/2010   Safety Issue:   No

14.  Secondary:   Quality of Life   [ Time Frame: 1400 days (3.85 years) post randomization ]
Results not yet reported.   Anticipated Reporting Date:   10/2010   Safety Issue:   No


  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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  More Information
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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:


Responsible Party: James E. Everhart, MD, MPH, Project Officer, 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, N01-DK-9-2323, N01-DK-9-2324, N01-DK-9-2325, N01-DK-9-2326, N01-DK-9-2321, N01-DK-9-2327, N01-DK-9-2319, N01-DK-9-2318, N01-DK-9-2320, N01-DK-9-2322
Study First Received: August 8, 2000
Results First Received: June 9, 2009
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration