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Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for HCV Genotype 1-infected Patients

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00495131
First received: June 29, 2007
Last updated: September 7, 2009
Last verified: September 2009
History of Changes
Results First Received: December 21, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C, Chronic
Intervention: Drug: Pegylated interferon alfa-2a plus ribavirin

  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
Recruitment period: 2006 June to September Location: academic centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No wash out period in the study; all were treatment-naive All the patients who were eligible in the study were assigned to either groups without exclusion.

Reporting Groups
  Description
Peginterferon and Ribavirin (24 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
Peginterferon and Ribavirin (48 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks

Participant Flow:   Overall Study
    Peginterferon and Ribavirin (24 Weeks)     Peginterferon and Ribavirin (48 Weeks)  
STARTED     154     154  
COMPLETED     147     148  
NOT COMPLETED     7     6  
Adverse Event                 6                 2  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Peginterferon and Ribavirin (24 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
Peginterferon and Ribavirin (48 Weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
Total Total of all reporting groups

Baseline Measures
    Peginterferon and Ribavirin (24 Weeks)     Peginterferon and Ribavirin (48 Weeks)     Total  
Number of Participants  
[units: participants]
 		  154     154     308  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     122     128     250  
>=65 years     32     26     58  
Age  
[units: years]
Mean ± Standard Deviation 		  54  ± 10     53  ± 11     53  ± 10  
Gender  
[units: participants]
 		     
Female     66     67     133  
Male     88     87     175  
Region of Enrollment  
[units: participants]
 		     
Taiwan     154     154     308  



  Outcome Measures
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1.  Primary:   Sustained Virologic Response   [ Time Frame: 18 months ]
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2.  Primary:   Sustained Biochemical Response   [ Time Frame: 18 months ]
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3.  Secondary:   Treatment-related Withdrawal Rate   [ Time Frame: 18 months ]
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4.  Secondary:   Histologic Response   [ Time Frame: 18 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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: Chen-Hua Liu, MD
Organization: National Taiwan University Hospital
phone: 886223123456 ext 63572
e-mail: jacque_liu@mail2000.com.tw


Publications:

Publications automatically indexed to this study:


Responsible Party: Dr. Jia-Horng Kao, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00495131     History of Changes
Other Study ID Numbers: 200705080M
Study First Received: June 29, 2007
Results First Received: December 21, 2008
Last Updated: September 7, 2009
Health Authority: Taiwan: Department of Health