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Trial record 25 of 25 for:    "Liver Cirrhosis" | "Peginterferon alfa-2a"

Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3

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ClinicalTrials.gov Identifier: NCT00056862
Recruitment Status : Completed
First Posted : March 25, 2003
Results First Posted : June 27, 2011
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 58
Recruitment Details Between Dec 2003 and Dec 2004, 31 patients were enrolled into the low-dose group and were treated with peginterferon alfa-2a 90ug/week and ribavirin 400 mg/twice daily for 24 week. From Feb 2005, all subsequent patients were enrolled into a standard-dose group and treated for 24 weeks with the doses of the approved regimen.
Pre-assignment Details  
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3. All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Period Title: Overall Study
Started 31 27
Completed 30 27
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Low Dose Group Standard Dose Group Total
Hide Arm/Group Description All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3. All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3. Total of all reporting groups
Overall Number of Baseline Participants 30 27 57
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 27 participants 57 participants
48
(29 to 62)
47
(26 to 69)
48
(26 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Female
15
  50.0%
14
  51.9%
29
  50.9%
Male
15
  50.0%
13
  48.1%
28
  49.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Caucasian 26 20 46
Asian 2 5 7
Hispanic 1 0 1
African-American 1 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 27 participants 57 participants
30 27 57
ALT  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 30 participants 27 participants 57 participants
91  (69) 97  (85) 94  (77)
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log IU/mL
Number Analyzed 30 participants 27 participants 57 participants
6.3  (0.82) 5.9  (1.02) 6.1  (0.92)
Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
HCV Genotype 2 21 13 34
HCV Genotype 3 9 14 23
1.Primary Outcome
Title Virological Response (Intention to Treat)
Hide Description Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.
Time Frame 6 months after stopping therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description:
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Overall Number of Participants Analyzed 30 27
Measure Type: Number
Unit of Measure: participants
Sustained Virological Response (SVR) 19 21
Relapse/breakthrough 7 2
Nonresponse 3 1
Treatment stopped for adverse event 0 3
Lost to follow-up 1 0
2.Primary Outcome
Title Virological Response Category (Per Protocol)
Hide Description Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.
Time Frame 6 months after therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description:
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Overall Number of Participants Analyzed 28 23
Measure Type: Number
Unit of Measure: participants
SVR 19 20
Relapse/breakthrough 7 2
Nonresponse 2 1
3.Secondary Outcome
Title First Phase Decline in Logarithm of HCV RNA Level
Hide Description The 1st phase decline is defined as the log difference between baseline HCV RNA level and the level on day 2 of treatment (see Neumann et al, Science, 1998).
Time Frame 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description:
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: logIU/mL
1.15  (0.88) 2.20  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Group, Standard Dose Group
Comments Null hypothesis: first phase decline in HCV RNA are the same for the two groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Slope of Second Phase Decline in HCV Levels
Hide Description The 2nd phase slope is defined as the slope of the logarithmic viral levels from week 1 to week 4 of treatment (see Neumann et al, Science, 1998).
Time Frame day 7 to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description:
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: logIU/mL
1.14  (0.69) 1.39  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Group, Standard Dose Group
Comments Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Time to Negativity
Hide Description Time from treatment initiation to the first negative HCV RNA test during treatment
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description:
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
Overall Number of Participants Analyzed 30 27
Median (95% Confidence Interval)
Unit of Measure: days
42
(32 to 51)
28
(19 to 37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Group, Standard Dose Group
Comments Null hypothesis: the time to negativity for the two groups are same
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame 72 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Group Standard Dose Group
Hide Arm/Group Description All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3. All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
All-Cause Mortality
Low Dose Group Standard Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Group Standard Dose Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      3/27 (11.11%)    
Cardiac disorders     
Mastoiditis complicated by myocardial infarction, heart failure, coronary bypass surgery and death   0/30 (0.00%)  0 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders     
Melanoma and death   0/30 (0.00%)  0 1/27 (3.70%)  1
Social circumstances     
Heroin overdose leading to death   0/30 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Low Dose Group Standard Dose Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      1/27 (3.70%)    
Blood and lymphatic system disorders     
Sarcoidosis development   1/30 (3.33%)  1 0/27 (0.00%)  0
Severe hemolysis requiring transfusion   0/30 (0.00%)  0 1/27 (3.70%)  1
Cardiac disorders     
Atrial fibrillation (off treatment),   1/30 (3.33%)  1 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jay H. Hoofnagle, M.D.
Organization: National Institute of Diabetes and Digestive and Kidney Diseases
Phone: 3014961333
EMail: hoofnaglej@extra.niddk.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier: NCT00056862     History of Changes
Other Study ID Numbers: 030136
03-DK-0136 ( Other Identifier: NIH Clinical Center )
First Submitted: March 25, 2003
First Posted: March 25, 2003
Results First Submitted: November 12, 2010
Results First Posted: June 27, 2011
Last Update Posted: December 6, 2013