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PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370AM2)(COMPLETED)
This study has been completed.
Study NCT00039871   Information provided by Schering-Plough
First Received: June 13, 2002   Last Updated: October 13, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions: Hepatitis
Hepatitis C, Chronic
Fibrosis
Liver Cirrhosis
Interventions: Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
Drug: REBETOL (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
Enrolled 2333; 21 subjects excluded due to Good Clinical Practice (GCP) non-compliance.

Reporting Groups
  Description
PegIntron Plus Rebetol No text entered.

Participant Flow:   Overall Study
  PegIntron Plus Rebetol
STARTED   2312[1]
COMPLETED   928  
NOT COMPLETED   1384  
      Adverse Event               165  
      Lost to Follow-up               18  
      Protocol Violation               24  
      Withdrawal by Subject               97  
      Did not meet eligibility criteria               11  
      Administrative               1  
      Discontinued at Week 12 per protocol               1061  
      Never entered follow-up               7  
[1] Enrolled 2333; 21 subjects excluded due to GCP non-compliance



  Baseline Characteristics
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Reporting Groups
  Description
PegIntron Plus Rebetol No text entered.

Baseline Measures
  PegIntron Plus Rebetol
Number of Participants  
[units: participants]
 		2312
Age  
[units: number of subjects]
 		 
<=18 years 0
Between 18 and 65 years 2267
>=65 years 45
Age  
[units: years]
Mean ± Standard Deviation 		49.2 ± 8.1
Gender  
[units: number of subjects]
 		 
Female 662
Male 1650
Hepatitis C Virus (HCV) Genotype  
[units: number of participants]
 		 
Genotype 1 1859
Genotype 2 75
Genotype 3 293
Genotype 4 68
Nontypable 8
Missing 9
METAVIR Fibrosis score[1]
[units: number of participants]
 		 
F1 2
F2 658
F3 676
F4 974
Missing 2
[1]

The METAVIR scoring system for hepatic fibrosis is as follows:

  • F0= no fibrosis
  • F1 = portal fibrosis without septa
  • F2 = portal fibrosis with few septa
  • F3= septal fibrosis without cirrhosis
  • F4= cirrhosis



  Outcome Measures
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1.  Primary:   Sustained Virologic Response (SVR) Rate   [ Assessed at end of 24 weeks posttreatment follow-up ]
  Show Outcome Measure 1

2.  Secondary:   Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12   [ 24 weeks posttreatment ]
  Show Outcome Measure 2

3.  Secondary:   Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12   [ 24 weeks posttreatment ]
  Show Outcome Measure 3


  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 Plus Rebetol No text entered.

Other Adverse Events
  PegIntron Plus Rebetol
Total, other (not including serious) adverse events  
# participants affected / at risk 2201  
Blood and lymphatic system disorders  
ANAEMIA   † A
      # participants affected / at risk
      # events
372/2312 (16.09%)
721  
LEUKOPENIA   † A
      # participants affected / at risk
      # events
239/2312 (10.34%)
538  
NEUTROPENIA   † A
      # participants affected / at risk
      # events
455/2312 (19.68%)
1271  
THROMBOCYTOPENIA   † A
      # participants affected / at risk
      # events
174/2312 (7.53%)
436  
Gastrointestinal disorders  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
      # events
155/2312 (6.70%)
206  
DIARRHOEA   † A
      # participants affected / at risk
      # events
342/2312 (14.79%)
486  
DRY MOUTH   † A
      # participants affected / at risk
      # events
145/2312 (6.27%)
155  
DYSPEPSIA   † A
      # participants affected / at risk
      # events
129/2312 (5.58%)
150  
NAUSEA   † A
      # participants affected / at risk
      # events
587/2312 (25.39%)
925  
VOMITING   † A
      # participants affected / at risk
      # events
210/2312 (9.08%)
281  
General disorders  
ASTHENIA   † A
      # participants affected / at risk
      # events
496/2312 (21.45%)
1086  
CHILLS   † A
      # participants affected / at risk
      # events
510/2312 (22.06%)
768  
FATIGUE   † A
      # participants affected / at risk
      # events
759/2312 (32.83%)
1108  
INFLUENZA LIKE ILLNESS   † A
      # participants affected / at risk
      # events
493/2312 (21.32%)
1285  
INJECTION SITE ERYTHEMA   † A
      # participants affected / at risk
      # events
237/2312 (10.25%)
326  
INJECTION SITE REACTION   † A
      # participants affected / at risk
      # events
120/2312 (5.19%)
128  
IRRITABILITY   † A
      # participants affected / at risk
      # events
398/2312 (17.21%)
566  
PYREXIA   † A
      # participants affected / at risk
      # events
900/2312 (38.93%)
2406  
Investigations  
WEIGHT DECREASED   † A
      # participants affected / at risk
      # events
154/2312 (6.66%)
191  
Metabolism and nutrition disorders  
ANOREXIA   † A
      # participants affected / at risk
      # events
286/2312 (12.37%)
365  
DECREASED APPETITE   † A
      # participants affected / at risk
      # events
202/2312 (8.74%)
222  
Musculoskeletal and connective tissue disorders  
ARTHRALGIA   † A
      # participants affected / at risk
      # events
391/2312 (16.91%)
686  
BACK PAIN   † A
      # participants affected / at risk
      # events
172/2312 (7.44%)
216  
MYALGIA   † A
      # participants affected / at risk
      # events
714/2312 (30.88%)
2249  
Nervous system disorders  
DIZZINESS   † A
      # participants affected / at risk
      # events
251/2312 (10.86%)
358  
HEADACHE   † A
      # participants affected / at risk
      # events
938/2312 (40.57%)
2801  
Psychiatric disorders  
ANXIETY   † A
      # participants affected / at risk
      # events
212/2312 (9.17%)
289  
DEPRESSION   † A
      # participants affected / at risk
      # events
281/2312 (12.15%)
383  
INSOMNIA   † A
      # participants affected / at risk
      # events
519/2312 (22.45%)
772  
Respiratory, thoracic and mediastinal disorders  
COUGH   † A
      # participants affected / at risk
      # events
374/2312 (16.18%)
447  
DYSPNOEA   † A
      # participants affected / at risk
      # events
250/2312 (10.81%)
313  
Skin and subcutaneous tissue disorders  
ALOPECIA   † A
      # participants affected / at risk
      # events
392/2312 (16.96%)
417  
DRY SKIN   † A
      # participants affected / at risk
      # events
196/2312 (8.48%)
220  
PRURITUS   † A
      # participants affected / at risk
      # events
358/2312 (15.48%)
471  
RASH   † A
      # participants affected / at risk
      # events
224/2312 (9.69%)
297  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 10.0


  More Information
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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
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 Group )
Study ID Numbers: P02370
Study First Received: June 13, 2002
Results First Received: September 29, 2008
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00039871     History of Changes
Health Authority: United States: Food and Drug Administration





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