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Trial record 12 of 538 for:    IFNA2 AND RBV AND Hepatitis

Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin for Treatment-Naïve Hemodialysis Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00491244
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : December 13, 2013
Last Update Posted : February 10, 2014
Sponsor:
Collaborators:
National Science Council, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Interventions Drug: Peginterferon alfa-2a and ribavirin
Drug: Peginterferon alfa-2a
Enrollment 377
Recruitment Details Recruitment from 1 June, 2007 to 9 May, 2012 Location: 8 academic centers in Taiwan
Pre-assignment Details  
Arm/Group Title Peginterferon and Ribavirin Peginterferon
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 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Period Title: Overall Study
Started 189 188
Completed 162 168
Not Completed 27 20
Arm/Group Title Peginterferon and Ribavirin Peginterferon 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 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks) Total of all reporting groups
Overall Number of Baseline Participants 189 188 377
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
189
 100.0%
188
 100.0%
377
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants 188 participants 377 participants
51  (10) 51  (11) 51  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 188 participants 377 participants
Female
76
  40.2%
76
  40.4%
152
  40.3%
Male
113
  59.8%
112
  59.6%
225
  59.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 189 participants 188 participants 377 participants
189 188 377
1.Primary Outcome
Title Sustained Virologic Response (SVR)Rate
Hide Description [Not Specified]
Time Frame 1.5 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were analyzed if they received at least one dose of the study medication
Arm/Group Title Peginterferon and Ribavirin Peginterferon
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 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Overall Number of Participants Analyzed 189 188
Measure Type: Number
Unit of Measure: participants
130 72
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon and Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.80
Confidence Interval (2-Sided) 95%
1.46 to 2.21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Adverse Event (AE)-Related Withdrawal Rate
Hide Description [Not Specified]
Time Frame 1.5 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were analyzed if they received at least one dose of the study medication; monitoring the events until the last visit
Arm/Group Title Peginterferon and Ribavirin Peginterferon
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 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
Overall Number of Participants Analyzed 189 188
Measure Type: Number
Unit of Measure: participants
Advese event related withdrawal rate 12 7
Non withdrawal 177 171
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peginterferon and Ribavirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
0.65 to 4.01
Estimation Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peginterferon and Ribavirin Peginterferon
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 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks) Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
All-Cause Mortality
Peginterferon and Ribavirin Peginterferon
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peginterferon and Ribavirin Peginterferon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/189 (4.23%)      7/188 (3.72%)    
Cardiac disorders     
Postural dizziness  1  2/189 (1.06%)  2 0/188 (0.00%)  0
Gastrointestinal disorders     
Intractable diarrhea  1  1/189 (0.53%)  1 0/188 (0.00%)  0
Peptic ulcer bleeding  1  0/189 (0.00%)  0 1/188 (0.53%)  1
Infections and infestations     
Cholangitis  1  0/189 (0.00%)  0 1/188 (0.53%)  1
Peritonitis  1  1/189 (0.53%)  1 0/188 (0.00%)  0
Pneumonia  1  2/189 (1.06%)  2 3/188 (1.60%)  3
Salmonella gastroenteritis  1  0/189 (0.00%)  0 1/188 (0.53%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatocellular carcinoma  1  1/189 (0.53%)  1 0/188 (0.00%)  0
Psychiatric disorders     
Major depression  1  0/189 (0.00%)  0 1/188 (0.53%)  1
Skin and subcutaneous tissue disorders     
Stevens-Johnson sybdrome  1  1/189 (0.53%)  1 0/188 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, DAIDS AE grade table
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peginterferon and Ribavirin Peginterferon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   170/189 (89.95%)      154/188 (81.91%)    
Blood and lymphatic system disorders     
Anemia  1 [1]  134/189 (70.90%)  134 13/188 (6.91%)  13
Neutropenia  1 [2]  30/189 (15.87%)  30 26/188 (13.83%)  26
Thrombocytopenia  1 [3]  19/189 (10.05%)  19 21/188 (11.17%)  21
Gastrointestinal disorders     
Anorexia  1  44/189 (23.28%)  44 38/188 (20.21%)  38
Diarrhea  1  22/189 (11.64%)  22 20/188 (10.64%)  20
Constipation  1  16/189 (8.47%)  16 15/188 (7.98%)  15
Immune system disorders     
Flu-like syndrome  1  47/189 (24.87%)  47 50/188 (26.60%)  50
Nervous system disorders     
Fatigue  1  106/189 (56.08%)  106 97/188 (51.60%)  97
Headache  1  51/189 (26.98%)  51 48/188 (25.53%)  48
Insomnia  1  62/189 (32.80%)  62 66/188 (35.11%)  66
Psychiatric disorders     
Irritability  1  21/189 (11.11%)  21 19/188 (10.11%)  19
Depression  1  25/189 (13.23%)  25 23/188 (12.23%)  23
Respiratory, thoracic and mediastinal disorders     
Cough  1  26/189 (13.76%)  26 10/188 (5.32%)  10
Skin and subcutaneous tissue disorders     
Dermatitis  1  43/189 (22.75%)  43 38/188 (20.21%)  38
Injection site reaction  1  27/189 (14.29%)  27 27/188 (14.36%)  27
Hair loss  1  47/189 (24.87%)  47 43/188 (22.87%)  43
Indicates events were collected by systematic assessment
1
Term from vocabulary, DAIDS AE grade table
[1]
Hemoglobin level < 8.5 g/dL
[2]
Absolute neutrophil count < 750 x 10^9 cells/L
[3]
Platelet count < 50 x 10^9 cells/L
  1. Open-label trial
  2. Results may not be generalizable to peritoneal dialysis patients
  3. Higher percentages of favorable IL28B genotypes
  4. Secondary endpoint may not be powered to detect the differences
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: Dr. Chen-Hua Liu
Organization: National Taiwan University Hospital
Phone: +886-2-23123456 ext 63572
EMail: jacque_liu@mail2000.com.tw
Publications:
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00491244     History of Changes
Other Study ID Numbers: 200703010M
First Submitted: June 23, 2007
First Posted: June 26, 2007
Results First Submitted: September 29, 2013
Results First Posted: December 13, 2013
Last Update Posted: February 10, 2014