ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 35
Recruitment Details Recruitment period: June 2006- June 2007 Location: 5 academic centers
Pre-assignment Details Wash out period: 6 months after last interferon intervention
Arm/Group Title Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Hide Arm/Group Description 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 alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Period Title: Overall Study
Started 25 10
Completed 18 8
Not Completed 7 2
Reason Not Completed
Adverse Event             5             1
Withdrawal by Subject             2             1
Arm/Group Title Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2) Total
Hide Arm/Group Description 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 alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 25 10 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 10 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
10
 100.0%
35
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 10 participants 35 participants
48  (8) 44  (12) 47  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 10 participants 35 participants
Female
8
  32.0%
4
  40.0%
12
  34.3%
Male
17
  68.0%
6
  60.0%
23
  65.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 25 participants 10 participants 35 participants
25 10 35
1.Primary Outcome
Title 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)
Hide Description
  1. Number of participants with sustained virologic response (SVR): number of patients with undetectable HCV RNA 6 months off therapy by real-time PCR test (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, limit of detection < 25 IU/mL)
  2. Number of participants who droppoed out of the study prematurely due to adverse events (AEs): number of patients who prematurely withdrew from the study due to any adverse events
Time Frame 1.5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome measures:intention-to-treat (ITT) analysis Imputation technique: last observation carried forward
Arm/Group Title Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Hide Arm/Group Description:
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 alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Overall Number of Participants Analyzed 25 10
Measure Type: Number
Unit of Measure: Participants
Sustained virologic response (SVR) 13 8
Drop-out 7 2
2.Secondary Outcome
Title Number of Participants With Histologic Response(HR)
Hide Description Number of participants with histologic response (HR): number of patients who had improvement of as least 2 scores at the end of follow-up liver biopsy compared to baseline liver biopsy by Ishak scoring system (the sum of Ishak necroinflammation score (0-18) and Ishak fibrosis score (0-6); the higher the total scores, the severer the histologic changes)
Time Frame 1.5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Hide Arm/Group Description:
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 alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
Overall Number of Participants Analyzed 25 10
Measure Type: Number
Unit of Measure: Participants
11 6
Time Frame 18 months
Adverse Event Reporting Description Constitutional symptoms and abnormal laboratory tests
 
Arm/Group Title Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Hide Arm/Group Description 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 alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
All-Cause Mortality
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      1/10 (10.00%)    
Eye disorders     
Optic neuritis  1  1/25 (4.00%)  1 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Interstitial pneumonia  1  1/25 (4.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1) Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/25 (88.00%)      8/10 (80.00%)    
Blood and lymphatic system disorders     
Anemia  1  20/25 (80.00%)  20 6/10 (60.00%)  6
Neutropenia  1  4/25 (16.00%)  4 2/10 (20.00%)  2
Thrombocytopenia  1  3/25 (12.00%)  3 2/10 (20.00%)  2
Ear and labyrinth disorders     
Nasal stuffiness  1  2/25 (8.00%)  2 0/10 (0.00%)  0
Gastrointestinal disorders     
Anorexia  1  5/25 (20.00%)  5 5/10 (50.00%)  5
Constipation  1  2/25 (8.00%)  2 1/10 (10.00%)  1
Diarrhea  1  4/25 (16.00%)  4 1/10 (10.00%)  1
General disorders     
Body weight loss  1  3/25 (12.00%)  3 1/10 (10.00%)  1
Immune system disorders     
Rigor  1  6/25 (24.00%)  6 2/10 (20.00%)  2
Arthralgia  1  1/25 (4.00%)  1 1/10 (10.00%)  1
Aphthous ulcer  1  4/25 (16.00%)  4 2/10 (20.00%)  2
Infections and infestations     
Fever  1  6/25 (24.00%)  6 3/10 (30.00%)  3
Musculoskeletal and connective tissue disorders     
Myalgia  1  4/25 (16.00%)  4 1/10 (10.00%)  1
Nervous system disorders     
Fatigue  1  14/25 (56.00%)  14 8/10 (80.00%)  8
Headache  1  7/25 (28.00%)  7 4/10 (40.00%)  4
Insomnia  1  7/25 (28.00%)  7 4/10 (40.00%)  4
Irritability  1  2/25 (8.00%)  2 1/10 (10.00%)  1
Depression  1  3/25 (12.00%)  3 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/25 (8.00%)  2 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  6/25 (24.00%)  6 2/10 (20.00%)  2
Dermatitis  1  4/25 (16.00%)  4 3/10 (30.00%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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
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