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
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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
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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.
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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
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 posted.   Anticipated Posting 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 posted.   Anticipated Posting Date:   10/2010   Safety Issue:   No

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

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


  Serious Adverse Events


  Other 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.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Peginterferon Alfa-2a 90 Mcg/Week     Standard of Care Followup  
Total, other (not including serious) adverse events      
# participants affected / at risk     486/517     492/533  
Blood and lymphatic system disorders      
Anemia    
# participants affected / at risk     26/517 (5.03%)     11/533 (2.06%)  
Cardiac disorders      
Hypertension    
# participants affected / at risk     42/517 (8.12%)     46/533 (8.63%)  
Endocrine disorders      
Diabetes    
# participants affected / at risk     33/517 (6.38%)     56/533 (10.51%)  
General disorders      
Chest pain    
# participants affected / at risk     42/517 (8.12%)     39/533 (7.32%)  
Diarrhea, loose stool    
# participants affected / at risk     48/517 (9.28%)     39/533 (7.32%)  
Nausea    
# participants affected / at risk     52/517 (10.06%)     34/533 (6.38%)  
Dizziness, vertigo, light-headedness    
# participants affected / at risk     42/517 (8.12%)     31/533 (5.82%)  
Headache    
# participants affected / at risk     77/517 (14.89%)     44/533 (8.26%)  
Insomnia, sleep disturbance    
# participants affected / at risk     92/517 (17.79%)     54/533 (10.13%)  
Memory loss, confusion    
# participants affected / at risk     58/517 (11.22%)     37/533 (6.94%)  
Tingling, numbness    
# participants affected / at risk     47/517 (9.09%)     21/533 (3.94%)  
Nervousness, irritability    
# participants affected / at risk     62/517 (11.99%)     23/533 (4.32%)  
Nonproductive cough    
# participants affected / at risk     34/517 (6.58%)     22/533 (4.13%)  
Dyspnea    
# participants affected / at risk     26/517 (5.03%)     18/533 (3.38%)  
Rash    
# participants affected / at risk     71/517 (13.73%)     45/533 (8.44%)  
Body aches, chills, fever    
# participants affected / at risk     86/517 (16.63%)     49/533 (9.19%)  
Fatigue, malaise, weakness    
# participants affected / at risk     141/517 (27.27%)     121/533 (22.70%)  
Localized edema    
# participants affected / at risk     63/517 (12.19%)     64/533 (12.01%)  
Hepatobiliary disorders      
Abdominal pain    
# participants affected / at risk     136/517 (26.31%)     134/533 (25.14%)  
Immune system disorders      
Pneumonia    
# participants affected / at risk     27/517 (5.22%)     23/533 (4.32%)  
Infections and infestations      
Cystitis, bladder infection    
# participants affected / at risk     41/517 (7.93%)     28/533 (5.25%)  
Pharyngitis    
# participants affected / at risk     26/517 (5.03%)     13/533 (2.44%)  
Sinusitis    
# participants affected / at risk     56/517 (10.83%)     37/533 (6.94%)  
Upper respiratory infection    
# participants affected / at risk     44/517 (8.51%)     57/533 (10.69%)  
Musculoskeletal and connective tissue disorders      
Arthralgia    
# participants affected / at risk     136/517 (26.31%)     119/533 (22.33%)  
Bursitis, tendonitis, enthesopathies    
# participants affected / at risk     14/517 (2.71%)     27/533 (5.07%)  
Limb pain    
# participants affected / at risk     36/517 (6.96%)     38/533 (7.13%)  
Muscle spasm    
# participants affected / at risk     52/517 (10.06%)     32/533 (6.00%)  
Muscle/back aches or pain    
# participants affected / at risk     145/517 (28.05%)     124/533 (23.26%)  
Psychiatric disorders      
Anxiety    
# participants affected / at risk     27/517 (5.22%)     29/533 (5.44%)  
Depression    
# participants affected / at risk     93/517 (17.99%)     89/533 (16.70%)  
Reproductive system and breast disorders      
Sexual dysfunction, impotence    
# participants affected / at risk     28/517 (5.42%)     12/533 (2.25%)  
Respiratory, thoracic and mediastinal disorders      
Bronchitis    
# participants affected / at risk     27/517 (5.22%)     24/533 (4.50%)  
Skin and subcutaneous tissue disorders      
Pruritis    
# participants affected / at risk     93/517 (17.99%)     70/533 (13.13%)  
Events were collected by systematic assessment



  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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