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Trial record 32 of 382 for:    IFNA2 AND RBV AND genotype

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

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ClinicalTrials.gov Identifier: NCT00495131
Recruitment Status : Completed
First Posted : July 2, 2007
Results First Posted : September 7, 2009
Last Update Posted : September 10, 2009
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Intervention Drug: Pegylated interferon alfa-2a plus ribavirin
Enrollment 308
Recruitment Details Recruitment period: 2006 June to September Location: academic centers
Pre-assignment Details 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.
Arm/Group Title Peginterferon and Ribavirin (24 Weeks) Peginterferon and Ribavirin (48 Weeks)
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 154 154
Completed 147 148
Not Completed 7 6
Reason Not Completed
Adverse Event             6             2
Lack of Efficacy             0             2
Lost to Follow-up             0             2
Withdrawal by Subject             1             0
Arm/Group Title Peginterferon and Ribavirin (24 Weeks) Peginterferon and Ribavirin (48 Weeks) Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 154 154 308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 154 participants 308 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
122
  79.2%
128
  83.1%
250
  81.2%
>=65 years
32
  20.8%
26
  16.9%
58
  18.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 154 participants 308 participants
54  (10) 53  (11) 53  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 154 participants 308 participants
Female
66
  42.9%
67
  43.5%
133
  43.2%
Male
88
  57.1%
87
  56.5%
175
  56.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 154 participants 154 participants 308 participants
154 154 308
1.Primary Outcome
Title Sustained Virologic Response
Hide Description Undetectable HCV RNA 6 months off therapy
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis by last observation carried forward
Arm/Group Title Peginterferon and Ribavirin (24 Weeks) Peginterferon and Ribavirin (48 Weeks)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 154 154
Measure Type: Number
Unit of Measure: participants
87 117
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon and Ribavirin (24 Weeks), Peginterferon and Ribavirin (48 Weeks)
Comments Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Sustained Biochemical Response
Hide Description Sustained biochemical response (SBR): alanine aminotransferase (ALT) normalization
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with end of follow-up alanine aminotransferase (ALT) levels
Arm/Group Title Peginterferon and Ribavirin (24 Weeks) Peginterferon and Ribavirin (48 Weeks)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 147 148
Measure Type: Number
Unit of Measure: Participants
75 107
3.Secondary Outcome
Title Treatment-related Withdrawal Rate
Hide Description Treatment-related withdrawal rate: patients who prematurely discontinued treatment due to treatment-related adverse events
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peginterferon and Ribavirin (24 Weeks) Peginterferon and Ribavirin (48 Weeks)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 154 154
Measure Type: Number
Unit of Measure: Participants
6 14
4.Secondary Outcome
Title Histologic Response
Hide Description Histologic response: improvement of at least 2 grade of scores by Ishak liver histologic classification by end of follow up liver biopsy to baseline liver biopsy
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data included for analysis only for patients with paired liver biopsies.
Arm/Group Title Peginterferon and Ribavirin (24 Weeks) Peginterferon and Ribavirin (48 Weeks)
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 120 124
Measure Type: Number
Unit of Measure: Participants
71 97
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chen-Hua Liu, MD
Organization: National Taiwan University Hospital
Phone: 886223123456 ext 63572
EMail: jacque_liu@mail2000.com.tw
Publications:
Layout table for additonal information
Responsible Party: Dr. Jia-Horng Kao, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00495131     History of Changes
Other Study ID Numbers: 200705080M
First Submitted: June 29, 2007
First Posted: July 2, 2007
Results First Submitted: December 21, 2008
Results First Posted: September 7, 2009
Last Update Posted: September 10, 2009