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Study Results
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Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569AM2)(COMPLETED)
This study has been completed.
Study NCT00048724   Information provided by Schering-Plough
First Received: November 6, 2002   Last Updated: October 13, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Uncontrolled, Parallel Assignment
Conditions: Chronic Hepatitis C
Cirrhosis
Intervention: Biological: peginterferon alfa-2b (SCH 54031)

  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
Analysis population is modified intent to treat (MITT), comprising 626 randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from analyses.

Reporting Groups
  Description
PegIntron PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control No text entered.

Participant Flow:   Overall Study
  PegIntron Untreated Control
STARTED   311     315  
COMPLETED   195     197  
NOT COMPLETED   116     118  
      Adverse Event               53                 12  
      Withdrawal by Subject               34                 54  
      Lost to Follow-up               5                 5  
      Protocol-defined Clinical Event               17                 32  
      Noncompliance With Protocol               4                 12  
      Did Not Meet Protocol Eligibility               2                 2  
      Administrative               1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
PegIntron PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control No text entered.

Baseline Measures
  PegIntron Untreated Control Total
Number of Participants  
[units: participants]
 		311 315 626
Age, Customized  
[units: Participants]
 		     
<=50 years 130 132 262
>50 years 181 183 364
Gender  
[units: Participants]
 		     
Female 105 100 205
Male 206 215 421



  Outcome Measures
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1.  Primary:   Time to Observation of the First Clinical Event Experienced by a Subject   [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]
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2.  Secondary:   Time to Observation of the Disease Progression Experienced by a Subject   [ Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

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

Reporting Groups
  Description
PegIntron No text entered.
Untreated Control No text entered.

Other Adverse Events
  PegIntron Untreated Control
Total, other (not including serious) adverse events    
# participants affected / at risk 290   260  
Blood and lymphatic system disorders    
LEUKOPENIA   † A
      # participants affected / at risk
      # events
20/311 (6.43%)
31  
8/315 (2.54%)
9  
NEUTROPENIA   † A
      # participants affected / at risk
      # events
43/311 (13.83%)
119  
18/315 (5.71%)
26  
SPLENOMEGALY   † A
      # participants affected / at risk
      # events
60/311 (19.29%)
69  
54/315 (17.14%)
61  
THROMBOCYTOPENIA   † A
      # participants affected / at risk
      # events
52/311 (16.72%)
122  
20/315 (6.35%)
41  
Gastrointestinal disorders    
ABDOMINAL PAIN   † A
      # participants affected / at risk
      # events
33/311 (10.61%)
40  
21/315 (6.67%)
27  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
      # events
45/311 (14.47%)
66  
46/315 (14.60%)
67  
CONSTIPATION   † A
      # participants affected / at risk
      # events
16/311 (5.14%)
20  
14/315 (4.44%)
17  
DIARRHOEA   † A
      # participants affected / at risk
      # events
37/311 (11.90%)
57  
25/315 (7.94%)
30  
DYSPEPSIA   † A
      # participants affected / at risk
      # events
20/311 (6.43%)
27  
21/315 (6.67%)
29  
GASTRITIS   † A
      # participants affected / at risk
      # events
20/311 (6.43%)
22  
40/315 (12.70%)
42  
NAUSEA   † A
      # participants affected / at risk
      # events
49/311 (15.76%)
62  
39/315 (12.38%)
58  
VARICES OESOPHAGEAL   † A
      # participants affected / at risk
      # events
35/311 (11.25%)
41  
52/315 (16.51%)
56  
VOMITING   † A
      # participants affected / at risk
      # events
18/311 (5.79%)
21  
11/315 (3.49%)
11  
General disorders    
ASTHENIA   † A
      # participants affected / at risk
      # events
45/311 (14.47%)
70  
37/315 (11.75%)
48  
CHILLS   † A
      # participants affected / at risk
      # events
26/311 (8.36%)
37  
3/315 (0.95%)
4  
FATIGUE   † A
      # participants affected / at risk
      # events
103/311 (33.12%)
152  
78/315 (24.76%)
92  
INFLUENZA LIKE ILLNESS   † A
      # participants affected / at risk
      # events
46/311 (14.79%)
61  
4/315 (1.27%)
4  
INJECTION SITE ERYTHEMA   † A
      # participants affected / at risk
      # events
36/311 (11.58%)
37  
0/315 (0.00%)
0  
IRRITABILITY   † A
      # participants affected / at risk
      # events
41/311 (13.18%)
48  
17/315 (5.40%)
18  
MALAISE   † A
      # participants affected / at risk
      # events
16/311 (5.14%)
41  
11/315 (3.49%)
13  
OEDEMA PERIPHERAL   † A
      # participants affected / at risk
      # events
19/311 (6.11%)
23  
29/315 (9.21%)
39  
PYREXIA   † A
      # participants affected / at risk
      # events
57/311 (18.33%)
163  
14/315 (4.44%)
15  
Hepatobiliary disorders    
HEPATOMEGALY   † A
      # participants affected / at risk
      # events
45/311 (14.47%)
61  
51/315 (16.19%)
62  
Infections and infestations    
BRONCHITIS   † A
      # participants affected / at risk
      # events
20/311 (6.43%)
28  
23/315 (7.30%)
38  
INFLUENZA   † A
      # participants affected / at risk
      # events
16/311 (5.14%)
18  
28/315 (8.89%)
37  
NASOPHARYNGITIS   † A
      # participants affected / at risk
      # events
20/311 (6.43%)
27  
25/315 (7.94%)
36  
SINUSITIS   † A
      # participants affected / at risk
      # events
17/311 (5.47%)
23  
17/315 (5.40%)
20  
URINARY TRACT INFECTION   † A
      # participants affected / at risk
      # events
9/311 (2.89%)
20  
16/315 (5.08%)
22  
Metabolism and nutrition disorders    
ANOREXIA   † A
      # participants affected / at risk
      # events
25/311 (8.04%)
32  
8/315 (2.54%)
10  
DECREASED APPETITE   † A
      # participants affected / at risk
      # events
21/311 (6.75%)
27  
5/315 (1.59%)
5  
Musculoskeletal and connective tissue disorders    
ARTHRALGIA   † A
      # participants affected / at risk
      # events
68/311 (21.86%)
120  
63/315 (20.00%)
90  
BACK PAIN   † A
      # participants affected / at risk
      # events
44/311 (14.15%)
47  
39/315 (12.38%)
51  
MUSCLE SPASMS   † A
      # participants affected / at risk
      # events
29/311 (9.32%)
38  
17/315 (5.40%)
19  
MYALGIA   † A
      # participants affected / at risk
      # events
76/311 (24.44%)
242  
19/315 (6.03%)
22  
PAIN IN EXTREMITY   † A
      # participants affected / at risk
      # events
23/311 (7.40%)
36  
13/315 (4.13%)
14  
Nervous system disorders    
DIZZINESS   † A
      # participants affected / at risk
      # events
22/311 (7.07%)
32  
20/315 (6.35%)
23  
HEADACHE   † A
      # participants affected / at risk
      # events
103/311 (33.12%)
249  
47/315 (14.92%)
62  
Psychiatric disorders    
ANXIETY   † A
      # participants affected / at risk
      # events
24/311 (7.72%)
46  
16/315 (5.08%)
19  
DEPRESSION   † A
      # participants affected / at risk
      # events
35/311 (11.25%)
41  
26/315 (8.25%)
35  
INSOMNIA   † A
      # participants affected / at risk
      # events
50/311 (16.08%)
77  
45/315 (14.29%)
55  
Renal and urinary disorders    
RENAL CYST   † A
      # participants affected / at risk
      # events
6/311 (1.93%)
7  
19/315 (6.03%)
19  
Respiratory, thoracic and mediastinal disorders    
COUGH   † A
      # participants affected / at risk
      # events
33/311 (10.61%)
46  
34/315 (10.79%)
46  
DYSPNOEA   † A
      # participants affected / at risk
      # events
17/311 (5.47%)
22  
14/315 (4.44%)
15  
EPISTAXIS   † A
      # participants affected / at risk
      # events
23/311 (7.40%)
30  
9/315 (2.86%)
9  
Skin and subcutaneous tissue disorders    
ALOPECIA   † A
      # participants affected / at risk
      # events
36/311 (11.58%)
41  
27/315 (8.57%)
30  
PRURITUS   † A
      # participants affected / at risk
      # events
42/311 (13.50%)
64  
27/315 (8.57%)
38  
RASH   † A
      # participants affected / at risk
      # events
31/311 (9.97%)
41  
10/315 (3.17%)
14  
SPIDER NAEVUS   † A
      # participants affected / at risk
      # events
14/311 (4.50%)
16  
17/315 (5.40%)
19  
Vascular disorders    
HYPERTENSION   † A
      # participants affected / at risk
      # events
41/311 (13.18%)
47  
38/315 (12.06%)
40  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 11.0


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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure )
Study ID Numbers: P02569
Study First Received: November 6, 2002
Results First Received: April 23, 2009
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00048724     History of Changes
Health Authority: United States: Food and Drug Administration





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