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Trial record 53 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

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

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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
Enrollment 1050
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Period Title: Overall Study
Started 517 533
Completed 447 [1] 452 [2]
Not Completed 70 81
Reason Not Completed
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
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup Total
Hide Arm/Group Description Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment Total of all reporting groups
Overall Number of Baseline Participants 517 533 1050
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 517 participants 533 participants 1050 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 517 participants 533 participants 1050 participants
51.1  (7.3) 50.1  (7.0) 50.6  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 517 participants 533 participants 1050 participants
Female
155
  30.0%
150
  28.1%
305
  29.0%
Male
362
  70.0%
383
  71.9%
745
  71.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 517 participants 533 participants 1050 participants
517 533 1050
1.Primary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
157
  30.4%
157
  29.5%
2.Primary Outcome
Title Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with Ishak fibrosis score <5 at baseline and at least one follow-up biopsy
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 273 274
Measure Type: Count of Participants
Unit of Measure: Participants
71
  26.0%
81
  29.6%
3.Primary Outcome
Title Death From Any Cause
Hide Description [Not Specified]
Time Frame 1400 days (3.85 years) post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
31
   6.0%
22
   4.1%
4.Primary Outcome
Title Development of Hepatocellular Carcinoma (HCC)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
13
   2.5%
16
   3.0%
5.Primary Outcome
Title Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
57
  11.0%
52
   9.8%
6.Primary Outcome
Title Variceal Hemorrhage
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
5
   1.0%
11
   2.1%
7.Primary Outcome
Title Ascites
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
32
   6.2%
27
   5.1%
8.Primary Outcome
Title Spontaneous Bacterial Peritonitis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.6%
3
   0.6%
9.Primary Outcome
Title Hepatic Encephalopathy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
15
   2.9%
22
   4.1%
10.Secondary Outcome
Title Serious Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
175
  33.8%
155
  29.1%
11.Secondary Outcome
Title Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Numbers of participants at 1.5 and 3.5 years are the number with biopsies at those time points
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 430 429
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5 years Number Analyzed 430 participants 429 participants
-0.07  (1.27) -0.09  (1.27)
3.5 years Number Analyzed 349 participants 350 participants
0.12  (1.36) 0.12  (1.43)
12.Secondary Outcome
Title Presumed Hepatocellular Carcinoma (HCC)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Measure Type: Count of Participants
Unit of Measure: Participants
10
   1.9%
9
   1.7%
13.Secondary Outcome
Title SF-36 Vitality Summary Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At each visit the analysis population is the number who completed the questionaire
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5 years Number Analyzed 487 participants 492 participants
-6.05  (20.5) -1.61  (19.5)
1.5 years Number Analyzed 468 participants 471 participants
-6.40  (20.31) -3.24  (20.34)
2.5 years Number Analyzed 436 participants 430 participants
-5.68  (21.71) -2.97  (19.73)
3.5 years Number Analyzed 226 participants 214 participants
-6.69  (19.83) -3.27  (23.3)
14.Secondary Outcome
Title SF-36 Physical Function Summary Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At each visit the analysis population is the number who completed the questionaire
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5 years Number Analyzed 483 participants 485 participants
-1.64  (8.66) -0.97  (8.52)
1.5 years Number Analyzed 460 participants 467 participants
-2.41  (9.10) -1.63  (9.29)
2.5 years Number Analyzed 434 participants 426 participants
-1.99  (9.87) -1.68  (9.23)
3.5 years Number Analyzed 223 participants 213 participants
-3.80  (9.56) -1.66  (9.10)
15.Secondary Outcome
Title SF-36 Mental Health Summary Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At each visit the analysis population is the number who completed the questionaire
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description:
Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
Overall Number of Participants Analyzed 517 533
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5 years Number Analyzed 483 participants 485 participants
-2.62  (9.58) -1.08  (9.73)
1.5 years Number Analyzed 460 participants 467 participants
-2.22  (9.68) -1.67  (9.57)
2.5 years Number Analyzed 434 participants 426 participants
-2.65  (10.17) -2.15  (10.00)
3.5 years Number Analyzed 223 participants 213 participants
-2.84  (9.56) -1.85  (10.88)
Time Frame Within 1400 days (3.83 years) after randomization
Adverse Event Reporting 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.
 
Arm/Group Title Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Hide Arm/Group Description Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
All-Cause Mortality
Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Affected / at Risk (%) Affected / at Risk (%)
Total   175/517 (33.85%)   155/533 (29.08%) 
Blood and lymphatic system disorders     
Anemia   3/517 (0.58%)  5/533 (0.94%) 
Thrombocytopenia or pancytopenia   4/517 (0.77%)  0/533 (0.00%) 
Cardiac disorders     
Atherosclerotic disease   16/517 (3.09%)  9/533 (1.69%) 
Arrhythmia   3/517 (0.58%)  9/533 (1.69%) 
Other cardiovascular or circulatory event   4/517 (0.77%)  5/533 (0.94%) 
Endocrine disorders     
Electrolyte, mineral, or water imbalance   6/517 (1.16%)  7/533 (1.31%) 
Diabetes and its complications   1/517 (0.19%)  2/533 (0.38%) 
Thyroid disease   2/517 (0.39%)  2/533 (0.38%) 
Gastrointestinal disorders     
Nonvariceal gastrointestinal bleeding   4/517 (0.77%)  9/533 (1.69%) 
Hernia or intestinal obstruction   5/517 (0.97%)  3/533 (0.56%) 
Other digestive system event   11/517 (2.13%)  15/533 (2.81%) 
General disorders     
Cardiovascular signs or symptoms  [1]  10/517 (1.93%)  6/533 (1.13%) 
Hepatobiliary signs or symptoms  [1]  8/517 (1.55%)  6/533 (1.13%) 
Neurologic signs or symptoms  [1]  7/517 (1.35%)  6/533 (1.13%) 
Digestive signs or symptoms  [1]  4/517 (0.77%)  3/533 (0.56%) 
Other general signs or symptoms  [1]  4/517 (0.77%)  8/533 (1.50%) 
Hepatobiliary disorders     
Gallbladder disease   13/517 (2.51%)  15/533 (2.81%) 
Other pancreatic or biliary disorders   7/517 (1.35%)  5/533 (0.94%) 
Liver-disease events other than primary or secondary outcomes  [2]  1/517 (0.19%)  1/533 (0.19%) 
Infections and infestations     
Mucocutaneous infection and infectious diseases   9/517 (1.74%)  16/533 (3.00%) 
Respiratory tract infections and infectious diseases   19/517 (3.68%)  11/533 (2.06%) 
Systemic infections and infectious diseases   10/517 (1.93%)  4/533 (0.75%) 
Other infections and infectious diseases   15/517 (2.90%)  19/533 (3.56%) 
Injury, poisoning and procedural complications     
Injury   4/517 (0.77%)  10/533 (1.88%) 
Drug reaction   4/517 (0.77%)  2/533 (0.38%) 
Liver-biopsy complication   8/517 (1.55%)  11/533 (2.06%) 
Musculoskeletal and connective tissue disorders     
Musculoskelatal surgery   25/517 (4.84%)  21/533 (3.94%) 
Arthritis or back pain   9/517 (1.74%)  6/533 (1.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm   8/517 (1.55%)  10/533 (1.88%) 
Benign neoplasm   1/517 (0.19%)  3/533 (0.56%) 
Nervous system disorders     
Cerebral aneurysm, infarct, or stroke   3/517 (0.58%)  4/533 (0.75%) 
Other neurologic event   3/517 (0.58%)  2/533 (0.38%) 
Psychiatric disorders     
Affective disorders or delirium   8/517 (1.55%)  4/533 (0.75%) 
Suicidal ideation or attempt   4/517 (0.77%)  4/533 (0.75%) 
Substance abuse   3/517 (0.58%)  1/533 (0.19%) 
Renal and urinary disorders     
Renal or urinary diseases   11/517 (2.13%)  8/533 (1.50%) 
Reproductive system and breast disorders     
Gynecologic, menstrual, or sexual disorders   2/517 (0.39%)  5/533 (0.94%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory disorders   2/517 (0.39%)  7/533 (1.31%) 
Skin and subcutaneous tissue disorders     
Benign skin and nail disorders   0/517 (0.00%)  2/533 (0.38%) 
Indicates events were collected by systematic assessment
[1]
These clinical signs and symptoms are not associated with a specific diagnosis but are still classified as a serious adverse event.
[2]
Liver-disease events not related to death or other study-related clinical primary or secondary outcomes of the trial
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon Alfa-2a 90 mcg/Week Standard of Care Followup
Affected / at Risk (%) Affected / at Risk (%)
Total   486/517 (94.00%)   492/533 (92.31%) 
Blood and lymphatic system disorders     
Anemia   26/517 (5.03%)  11/533 (2.06%) 
Cardiac disorders     
Hypertension   42/517 (8.12%)  46/533 (8.63%) 
Endocrine disorders     
Diabetes   33/517 (6.38%)  56/533 (10.51%) 
General disorders     
Chest pain   42/517 (8.12%)  39/533 (7.32%) 
Diarrhea, loose stool   48/517 (9.28%)  39/533 (7.32%) 
Nausea   52/517 (10.06%)  34/533 (6.38%) 
Dizziness, vertigo, light-headedness   42/517 (8.12%)  31/533 (5.82%) 
Headache   77/517 (14.89%)  44/533 (8.26%) 
Insomnia, sleep disturbance   92/517 (17.79%)  54/533 (10.13%) 
Memory loss, confusion   58/517 (11.22%)  37/533 (6.94%) 
Tingling, numbness   47/517 (9.09%)  21/533 (3.94%) 
Nervousness, irritability   62/517 (11.99%)  23/533 (4.32%) 
Nonproductive cough   34/517 (6.58%)  22/533 (4.13%) 
Dyspnea   26/517 (5.03%)  18/533 (3.38%) 
Rash   71/517 (13.73%)  45/533 (8.44%) 
Body aches, chills, fever   86/517 (16.63%)  49/533 (9.19%) 
Fatigue, malaise, weakness   141/517 (27.27%)  121/533 (22.70%) 
Localized edema   63/517 (12.19%)  64/533 (12.01%) 
Hepatobiliary disorders     
Abdominal pain   136/517 (26.31%)  134/533 (25.14%) 
Immune system disorders     
Pneumonia   27/517 (5.22%)  23/533 (4.32%) 
Infections and infestations     
Cystitis, bladder infection   41/517 (7.93%)  28/533 (5.25%) 
Pharyngitis   26/517 (5.03%)  13/533 (2.44%) 
Sinusitis   56/517 (10.83%)  37/533 (6.94%) 
Upper respiratory infection   44/517 (8.51%)  57/533 (10.69%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   136/517 (26.31%)  119/533 (22.33%) 
Bursitis, tendonitis, enthesopathies   14/517 (2.71%)  27/533 (5.07%) 
Limb pain   36/517 (6.96%)  38/533 (7.13%) 
Muscle spasm   52/517 (10.06%)  32/533 (6.00%) 
Muscle/back aches or pain   145/517 (28.05%)  124/533 (23.26%) 
Psychiatric disorders     
Anxiety   27/517 (5.22%)  29/533 (5.44%) 
Depression   93/517 (17.99%)  89/533 (16.70%) 
Reproductive system and breast disorders     
Sexual dysfunction, impotence   28/517 (5.42%)  12/533 (2.25%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis   27/517 (5.22%)  24/533 (4.50%) 
Skin and subcutaneous tissue disorders     
Pruritis   93/517 (17.99%)  70/533 (13.13%) 
Indicates events were collected by systematic assessment
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
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Name/Title: James E. Everhart, MD, MPH, Project Officer
Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-8878
EMail: EverhartJ@extra.niddk.nih.gov
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: 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 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2323 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2324 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2325 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2326 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2321 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2327 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2319 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2318 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2320 ( Other Grant/Funding Number: NIH NIDDK Contract )
N01-DK-9-2322 ( Other Grant/Funding Number: NIH NIDDK Contract )
First Submitted: August 8, 2000
First Posted: August 9, 2000
Results First Submitted: June 9, 2009
Results First Posted: September 4, 2009
Last Update Posted: May 11, 2018