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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
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

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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      489  94.6%      511  95.9%      1000  95.2% 
>=65 years      28   5.4%      22   4.1%      50   4.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.1  (7.3)   50.1  (7.0)   50.6  (7.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      155  30.0%      150  28.1%      305  29.0% 
Male      362  70.0%      383  71.9%      745  71.0% 
Region of Enrollment 
[Units: Participants]
     
United States   517   533   1050 


  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 ]

Measure Type Primary
Measure Title 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
Measure Description Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
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 
[Units: Participants]
Count of Participants
 157   157 

No statistical analysis provided for 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



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 ]

Measure Type Primary
Measure Title Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies
Measure Description For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)
Time Frame 1400 days (3.85 years) post randomization  

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.
Patients with Ishak fibrosis score <5 at baseline and at least one follow-up biopsy

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   273   274 
Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies 
[Units: Participants]
Count of Participants
 71   81 

No statistical analysis provided for Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies



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

Measure Type Primary
Measure Title Death From Any Cause
Measure Description No text entered.
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Death From Any Cause 
[Units: Participants]
Count of Participants
 31   22 

No statistical analysis provided for Death From Any Cause



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

Measure Type Primary
Measure Title Development of Hepatocellular Carcinoma (HCC)
Measure Description

A diagnosis of development of hepatocellular carcinoma (HCC) was based on either

  1. Histology showing HCC (from a biopsy, surgery, or autopsy) or
  2. A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml.
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Development of Hepatocellular Carcinoma (HCC) 
[Units: Participants]
Count of Participants
 13   16 

No statistical analysis provided for Development of Hepatocellular Carcinoma (HCC)



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 ]

Measure Type Primary
Measure Title Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits
Measure Description Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits 
[Units: Participants]
Count of Participants
 57   52 

No statistical analysis provided for Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits



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

Measure Type Primary
Measure Title Variceal Hemorrhage
Measure Description A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Variceal Hemorrhage 
[Units: Participants]
Count of Participants
 5   11 

No statistical analysis provided for Variceal Hemorrhage



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

Measure Type Primary
Measure Title Ascites
Measure Description

Any abdominal fluid which is:

  1. Mild, moderate or marked on ultrasound; or
  2. Progressive on serial physical examinations; or
  3. Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is “mild” (“barely detectable”) on physical examination requires ultrasound confirmation that is “mild”, “moderate” or “marked” ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition.
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Ascites 
[Units: Participants]
Count of Participants
 32   27 

No statistical analysis provided for Ascites



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

Measure Type Primary
Measure Title Spontaneous Bacterial Peritonitis
Measure Description Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Spontaneous Bacterial Peritonitis 
[Units: Participants]
Count of Participants
 3   3 

No statistical analysis provided for Spontaneous Bacterial Peritonitis



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

Measure Type Primary
Measure Title Hepatic Encephalopathy
Measure Description Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Hepatic Encephalopathy 
[Units: Participants]
Count of Participants
 15   22 

No statistical analysis provided for Hepatic Encephalopathy



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

Measure Type Secondary
Measure Title Serious Adverse Events
Measure Description

A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following:

  1. Death
  2. Is life threatening (risk of death at the time of the event)
  3. Requires in-patient hospitalization or prolongation of existing hospitalization
  4. Results in persistent or significant disability/incapacity
  5. Congenital abnormality or birth defect

Trial outcomes (except death) were not considered serious adverse events.

Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Serious Adverse Events 
[Units: Participants]
Count of Participants
 175   155 

No statistical analysis provided for Serious Adverse Events



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

Measure Type Secondary
Measure Title Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.
Measure Description Change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) by assessment of a liver-biopsy specimen obtained during the study (collected at baseline, Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)
Time Frame 1400 days (3.85 years) post randomization  

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.
Numbers of participants at 1.5 and 3.5 years are the number with biopsies at those time points

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   430   429 
Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy. 
[Units: Units on a scale]
Mean (Standard Deviation)
   
1.5 years     
Participants Analyzed   430   429 
1.5 years   -0.07  (1.27)   -0.09  (1.27) 
3.5 years     
Participants Analyzed   349   350 
3.5 years   0.12  (1.36)   0.12  (1.43) 

No statistical analysis provided for Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.



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

Measure Type Secondary
Measure Title Presumed Hepatocellular Carcinoma (HCC)
Measure Description

Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if:

  1. A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC.
  2. AFP> upper limit of normal (ULN) and 2 imaging studies showed a hepatic lesion with characteristics of HCC.
  3. A progressively enlarging hepatic lesion starting as a new defect resulting in patient death.
  4. A new hepatic defect with at least 1 characteristic scan and:

    1. Increase in size over time or
    2. Increasing AFP rising to a level of >200 ng/ml
Time Frame 1400 days (3.85 years) post randomization  

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
Presumed Hepatocellular Carcinoma (HCC) 
[Units: Participants]
Count of Participants
 10   9 

No statistical analysis provided for Presumed Hepatocellular Carcinoma (HCC)



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

Measure Type Secondary
Measure Title SF-36 Vitality Summary Score
Measure Description Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Vitality summary score. The SF-36 Vitality summary score is the sum of 4 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
Time Frame 0.5, 1.5, 2.5, and 3.5 years after randomization  

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.
At each visit the analysis population is the number who completed the questionaire

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
SF-36 Vitality Summary Score 
[Units: Units on a scale]
Mean (Standard Deviation)
   
0.5 years     
Participants Analyzed   487   492 
0.5 years   -6.05  (20.5)   -1.61  (19.5) 
1.5 years     
Participants Analyzed   468   471 
1.5 years   -6.40  (20.31)   -3.24  (20.34) 
2.5 years     
Participants Analyzed   436   430 
2.5 years   -5.68  (21.71)   -2.97  (19.73) 
3.5 years     
Participants Analyzed   226   214 
3.5 years   -6.69  (19.83)   -3.27  (23.3) 

No statistical analysis provided for SF-36 Vitality Summary Score



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

Measure Type Secondary
Measure Title SF-36 Physical Function Summary Score
Measure Description Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Physical Function summary score. The SF-36 Physical Function summary score is the sum of 10 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
Time Frame 0.5, 1.5, 2.5, and 3.5 years after randomization  

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.
At each visit the analysis population is the number who completed the questionaire

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
SF-36 Physical Function Summary Score 
[Units: Units on a scale]
Mean (Standard Deviation)
   
0.5 years     
Participants Analyzed   483   485 
0.5 years   -1.64  (8.66)   -0.97  (8.52) 
1.5 years     
Participants Analyzed   460   467 
1.5 years   -2.41  (9.10)   -1.63  (9.29) 
2.5 years     
Participants Analyzed   434   426 
2.5 years   -1.99  (9.87)   -1.68  (9.23) 
3.5 years     
Participants Analyzed   223   213 
3.5 years   -3.80  (9.56)   -1.66  (9.10) 

No statistical analysis provided for SF-36 Physical Function Summary Score



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

Measure Type Secondary
Measure Title SF-36 Mental Health Summary Score
Measure Description Change from baseline to years 0.5, 1.5, 2.5, and 3.5 in Short Form Health Survey (SF-36) Mental Health summary score. The SF-36 Mental Health summary score is the sum of 5 individual scores. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. A negative value indicates a decrease in quality of life from baseline.
Time Frame 0.5, 1.5, 2.5, and 3.5 years after randomization  

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.
At each visit the analysis population is the number who completed the questionaire

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

Measured Values
   Peginterferon Alfa-2a 90 mcg/Week   Standard of Care Followup 
Participants Analyzed   517   533 
SF-36 Mental Health Summary Score 
[Units: Units on a scale]
Mean (Standard Deviation)
   
0.5 years     
Participants Analyzed   483   485 
0.5 years   -2.62  (9.58)   -1.08  (9.73) 
1.5 years     
Participants Analyzed   460   467 
1.5 years   -2.22  (9.68)   -1.67  (9.57) 
2.5 years     
Participants Analyzed   434   426 
2.5 years   -2.65  (10.17)   -2.15  (10.00) 
3.5 years     
Participants Analyzed   223   213 
3.5 years   -2.84  (9.56)   -1.85  (10.88) 

No statistical analysis provided for SF-36 Mental Health Summary Score




  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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