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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:
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)
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 
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   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


  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 (94.00%)   492/533 (92.31%) 
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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