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Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538AM1 Part 1)(COMPLETED)
This study has been completed.
Study NCT00104052   Information provided by Schering-Plough
First Received: February 22, 2005   Last Updated: October 13, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition: Hepatitis C, Chronic
Interventions: Biological: peginterferon alfa-2b (SCH 54031)
Drug: ribavirin (SCH 18908)

  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
No text entered.

Reporting Groups
  Description
PEG-Intron Plus REBETOL SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.

Participant Flow:   Overall Study
  PEG-Intron Plus REBETOL
STARTED   107  
COMPLETED   78  
NOT COMPLETED   29  
      Adverse Event               1  
      Lack of Efficacy               26  
      Discontinuation unrelated to treatment               2  



  Baseline Characteristics
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Reporting Groups
  Description
PEG-Intron Plus REBETOL SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.

Baseline Measures
  PEG-Intron Plus REBETOL
Number of Participants  
[units: participants]
 		107
Age  
[units: years]
Mean ± Standard Deviation 		9.7 ± 4.0
Gender  
[units: participants]
 		 
Female 56
Male 51



  Outcome Measures

1.  Primary:   Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment   [ Up to 48-week treatment duration. Follow-up of 24 weeks. ]
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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
PEG-Intron Plus REBETOL No text entered.

Other Adverse Events
  PEG-Intron Plus REBETOL
Total, other (not including serious) adverse events  
# participants affected / at risk 107  
Blood and lymphatic system disorders  
ANAEMIA   † A
      # participants affected / at risk
      # events
12/107 (11.21%)
20  
LEUKOPENIA   † A
      # participants affected / at risk
      # events
11/107 (10.28%)
15  
LYMPHADENOPATHY   † A
      # participants affected / at risk
      # events
10/107 (9.35%)
14  
NEUTROPENIA   † A
      # participants affected / at risk
      # events
35/107 (32.71%)
61  
Eye disorders  
EYE PAIN   † A
      # participants affected / at risk
      # events
6/107 (5.61%)
7  
Gastrointestinal disorders  
ABDOMINAL PAIN   † A
      # participants affected / at risk
      # events
28/107 (26.17%)
58  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
      # events
15/107 (14.02%)
24  
APHTHOUS STOMATITIS   † A
      # participants affected / at risk
      # events
6/107 (5.61%)
12  
DIARRHOEA   † A
      # participants affected / at risk
      # events
16/107 (14.95%)
20  
NAUSEA   † A
      # participants affected / at risk
      # events
22/107 (20.56%)
41  
VOMITING   † A
      # participants affected / at risk
      # events
36/107 (33.64%)
76  
General disorders  
ASTHENIA   † A
      # participants affected / at risk
      # events
16/107 (14.95%)
40  
CHILLS   † A
      # participants affected / at risk
      # events
23/107 (21.50%)
58  
FATIGUE   † A
      # participants affected / at risk
      # events
32/107 (29.91%)
125  
INFLUENZA LIKE ILLNESS   † A
      # participants affected / at risk
      # events
10/107 (9.35%)
51  
INJECTION SITE ERYTHEMA   † A
      # participants affected / at risk
      # events
31/107 (28.97%)
50  
IRRITABILITY   † A
      # participants affected / at risk
      # events
16/107 (14.95%)
42  
MALAISE   † A
      # participants affected / at risk
      # events
10/107 (9.35%)
24  
PAIN   † A
      # participants affected / at risk
      # events
10/107 (9.35%)
20  
PYREXIA   † A
      # participants affected / at risk
      # events
86/107 (80.37%)
617  
Infections and infestations  
NASOPHARYNGITIS   † A
      # participants affected / at risk
      # events
11/107 (10.28%)
15  
PHARYNGITIS   † A
      # participants affected / at risk
      # events
6/107 (5.61%)
7  
PHARYNGITIS STREPTOCOCCAL   † A
      # participants affected / at risk
      # events
6/107 (5.61%)
6  
Investigations  
BLOOD THYROID STIMULATING HORMONE INCREASED   † A
      # participants affected / at risk
      # events
6/107 (5.61%)
9  
WEIGHT DECREASED   † A
      # participants affected / at risk
      # events
20/107 (18.69%)
29  
Metabolism and nutrition disorders  
ANOREXIA   † A
      # participants affected / at risk
      # events
31/107 (28.97%)
41  
DECREASED APPETITE   † A
      # participants affected / at risk
      # events
24/107 (22.43%)
34  
Musculoskeletal and connective tissue disorders  
ARTHRALGIA   † A
      # participants affected / at risk
      # events
18/107 (16.82%)
70  
BACK PAIN   † A
      # participants affected / at risk
      # events
8/107 (7.48%)
13  
MYALGIA   † A
      # participants affected / at risk
      # events
20/107 (18.69%)
100  
PAIN IN EXTREMITY   † A
      # participants affected / at risk
      # events
11/107 (10.28%)
28  
Nervous system disorders  
DIZZINESS   † A
      # participants affected / at risk
      # events
15/107 (14.02%)
25  
HEADACHE   † A
      # participants affected / at risk
      # events
71/107 (66.36%)
410  
Psychiatric disorders  
NERVOUSNESS   † A
      # participants affected / at risk
      # events
9/107 (8.41%)
9  
Respiratory, thoracic and mediastinal disorders  
COUGH   † A
      # participants affected / at risk
      # events
24/107 (22.43%)
31  
EPISTAXIS   † A
      # participants affected / at risk
      # events
7/107 (6.54%)
10  
PHARYNGOLARYNGEAL PAIN   † A
      # participants affected / at risk
      # events
15/107 (14.02%)
20  
Skin and subcutaneous tissue disorders  
ACNE   † A
      # participants affected / at risk
      # events
6/107 (5.61%)
6  
ALOPECIA   † A
      # participants affected / at risk
      # events
19/107 (17.76%)
21  
DRY SKIN   † A
      # participants affected / at risk
      # events
15/107 (14.02%)
19  
ECZEMA   † A
      # participants affected / at risk
      # events
9/107 (8.41%)
11  
ERYTHEMA   † A
      # participants affected / at risk
      # events
8/107 (7.48%)
9  
RASH   † A
      # participants affected / at risk
      # events
8/107 (7.48%)
14  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 10.1


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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
NONE  


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 Group )
Study ID Numbers: P02538: Part 1
Study First Received: February 22, 2005
Results First Received: November 14, 2008
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00104052     History of Changes
Health Authority: United States: Food and Drug Administration





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