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Trial record 2 of 2 for:    16830372 [PUBMED-IDS]

Retreatment of Dialysis Patients With Chronic Hepatitis C With Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin

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ClinicalTrials.gov Identifier: NCT00491179
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Sponsor:
Collaborators:
National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
National Taiwan University Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Hepatitis C
Hemodialysis
Intervention: Drug: Pegylated interferon alfa-2a and ribavirin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: June 2006- June 2007 Location: 5 academic centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash out period: 6 months after last interferon intervention

Reporting Groups
  Description
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks

Participant Flow:   Overall Study
    Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)   Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
STARTED   25   10 
COMPLETED   18   8 
NOT COMPLETED   7   2 
Adverse Event                5                1 
Withdrawal by Subject                2                1 



  Baseline Characteristics

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
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Total Total of all reporting groups

Baseline Measures
   Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)   Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   10   35 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   25   10   35 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (8)   44  (12)   47  (10) 
Gender 
[Units: Participants]
     
Female   8   4   12 
Male   17   6   23 
Region of Enrollment 
[Units: Participants]
     
Taiwan   25   10   35 


  Outcome Measures

1.  Primary:   1.Number of Participants With Sustained Virologic Response (SVR) 2.Number of Participants Who Droppoed Out of the Study Prematurely Due to Adverse Events (AEs)   [ Time Frame: 1.5 year ]

2.  Secondary:   Number of Participants With Histologic Response(HR)   [ Time Frame: 1.5 year ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


Publications:


Responsible Party: Dr. Chen-Hua Liu, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00491179     History of Changes
Other Study ID Numbers: 200703032M
First Submitted: June 23, 2007
First Posted: June 26, 2007
Results First Submitted: December 21, 2008
Results First Posted: November 13, 2009
Last Update Posted: November 13, 2009