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.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00039871
First received: June 13, 2002
Last updated: October 13, 2009
Last verified: October 2009
Results First Received: September 29, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
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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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
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   [ Time Frame: Assessed at end of 24 weeks posttreatment follow-up ]

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

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


  Serious Adverse Events


  Other Adverse Events


  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: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00039871     History of Changes
Other Study ID Numbers: P02370
Study First Received: June 13, 2002
Results First Received: September 29, 2008
Last Updated: October 13, 2009
Health Authority: United States: Food and Drug Administration