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Trial record 40 of 396 for:    IFNA2 AND RBV AND sustained

The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE) (IMPROVE)

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ClinicalTrials.gov Identifier: NCT00483938
Recruitment Status : Completed
First Posted : June 8, 2007
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Pegylated-interferon Alfa-2a
Drug: Ribavirin
Enrollment 236
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F) Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Hide Arm/Group Description Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks. Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Period Title: Overall Study
Started 41 43 30 31 25 26 40
Completed 36 24 30 25 23 18 0
Not Completed 5 19 0 6 2 8 40
Reason Not Completed
Protocol Violation             0             0             0             0             0             0             3
Withdrawal by Subject             1             6             0             0             1             3             2
Lost to Follow-up             1             2             0             2             1             1             3
Death             0             2             0             0             0             0             0
Other             3             9             0             4             0             4             32
Arm/Group Title Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F) Pegylated-interferon Alfa-2a + Ribavirin (Group NR) Total
Hide Arm/Group Description Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks. Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 41 43 30 31 25 26 40 236
Hide Baseline Analysis Population Description
The safety (SAF) population included participants who received at least one dose of study medication and had at least one post-baseline safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 43 participants 30 participants 31 participants 25 participants 26 participants 40 participants 236 participants
50.9  (8.55) 51.0  (7.39) 48.7  (11.54) 47.8  (9.16) 47.0  (10.38) 47.0  (9.76) 51.7  (7.52) 49.5  (9.13)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 43 participants 30 participants 31 participants 25 participants 26 participants 40 participants 236 participants
Female
16
  39.0%
19
  44.2%
10
  33.3%
12
  38.7%
6
  24.0%
9
  34.6%
13
  32.5%
85
  36.0%
Male
25
  61.0%
24
  55.8%
20
  66.7%
19
  61.3%
19
  76.0%
17
  65.4%
27
  67.5%
151
  64.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
Hide Description SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.
Time Frame At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included randomized participants who received at least one dose of study medication and who had a baseline HCV-RNA which was at least 15 IU/mL. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.
Arm/Group Title Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Hide Arm/Group Description:
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
Overall Number of Participants Analyzed 41 43
Measure Type: Number
Unit of Measure: percentage of participants
48.8 39.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group A), Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Comments SVR: Group A versus Group B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.510
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With SVR (Groups C, D, E, and F)
Hide Description SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.
Time Frame At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Here, “Number of Participants Analyzed” = the participants who were evaluable for this outcome measure.
Arm/Group Title Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Hide Arm/Group Description:
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Overall Number of Participants Analyzed 30 31 25 25
Measure Type: Number
Unit of Measure: percentage of participants
73.3 74.2 84.0 84.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group C), Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Comments SVR: Group C versus Group D
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group E), Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Comments SVR: Group E versus Group F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
Hide Description End of treatment response (ETR) was defined as “Success” if the HCV-RNA levels were <15 IU/mL at the end of treatment. Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as “Success”, if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as “Success”, if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point.
Time Frame Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Hide Arm/Group Description:
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Overall Number of Participants Analyzed 41 43 30 31 25 25
Measure Type: Number
Unit of Measure: percentage of participants
ETR 80.5 76.7 96.7 90.3 92.0 100.0
Complete EVR 0 0 93.3 96.8 88.0 92.0
Partial EVR 0 0 0 3.2 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group A), Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Comments ETR: Group A versus Group B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group C), Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Comments ETR: Group C versus Group D
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group E), Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Comments ETR: Group E versus Group F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.490
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group C), Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Comments Complete EVR: Group C versus Group D
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.363
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Pegylated-interferon Alfa-2a + Ribavirin (Group E), Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Comments Complete EVR: Group E versus Group F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Baseline up to 96 weeks
Adverse Event Reporting Description Safety population
 
Arm/Group Title Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F) Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Hide Arm/Group Description Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks. Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks. Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks. Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks. Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks. Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
All-Cause Mortality
Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F) Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F) Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/41 (9.76%)   6/43 (13.95%)   5/30 (16.67%)   4/31 (12.90%)   0/25 (0.00%)   4/26 (15.38%)   3/40 (7.50%) 
Blood and lymphatic system disorders               
Pancytopenia * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Cardiac disorders               
Atrial fibrillation * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Gastrointestinal disorders               
Abdominal pain * 1  0/41 (0.00%)  0/43 (0.00%)  1/30 (3.33%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Caecitis * 1  0/41 (0.00%)  0/43 (0.00%)  1/30 (3.33%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
General disorders               
Chest pain * 1  0/41 (0.00%)  1/43 (2.33%)  1/30 (3.33%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Non-cardiac chest pain * 1  0/41 (0.00%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Hepatobiliary disorders               
Cholecystitis * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Hepatic cirrhosis * 1  1/41 (2.44%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Infections and infestations               
Appendicitis * 1  1/41 (2.44%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/40 (2.50%) 
Cellulitis * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Kidney infection * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Pulmonary sepsis * 1  0/41 (0.00%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Injury, poisoning and procedural complications               
Drug toxicity * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/40 (2.50%) 
Fall * 1  0/41 (0.00%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Multiple drug overdose * 1  1/41 (2.44%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthritis * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Spinal column stenosis * 1  0/41 (0.00%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Nervous system disorders               
Haemorrhage intracranial * 1  0/41 (0.00%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Hepatic encephalopathy * 1  1/41 (2.44%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Loss of consciousness * 1  0/41 (0.00%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Syncope * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/40 (2.50%) 
Psychiatric disorders               
Emotional/mental (depression, anxiety, irritability, forgetfulness, confusion, anger) * 1 [1]  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/40 (2.50%) 
Suicide attempt * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Social circumstances               
Pregnancy of partner * 1  0/41 (0.00%)  0/43 (0.00%)  2/30 (6.67%)  0/31 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
[1]
This was reported as ‘adverse event (AE) cluster’ i.e. combination of multiple AEs and not as separate AE preferred terms (PTs).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pegylated-interferon Alfa-2a + Ribavirin (Group A) Pegylated-interferon Alfa-2a + Ribavirin (Group B) Pegylated-interferon Alfa-2a + Ribavirin (Group C) Pegylated-interferon Alfa-2a + Ribavirin (Group D) Pegylated-interferon Alfa-2a + Ribavirin (Group E) Pegylated-interferon Alfa-2a + Ribavirin (Group F) Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/41 (95.12%)   43/43 (100.00%)   30/30 (100.00%)   31/31 (100.00%)   25/25 (100.00%)   25/26 (96.15%)   35/40 (87.50%) 
Blood and lymphatic system disorders               
Anemia * 1  12/41 (29.27%)  16/43 (37.21%)  5/30 (16.67%)  7/31 (22.58%)  4/25 (16.00%)  4/26 (15.38%)  1/40 (2.50%) 
Neutropenia * 1  9/41 (21.95%)  9/43 (20.93%)  8/30 (26.67%)  3/31 (9.68%)  6/25 (24.00%)  9/26 (34.62%)  1/40 (2.50%) 
Thrombocytopenia * 1  2/41 (4.88%)  3/43 (6.98%)  2/30 (6.67%)  1/31 (3.23%)  1/25 (4.00%)  1/26 (3.85%)  2/40 (5.00%) 
Endocrine disorders               
Hyperthyroidism * 1  2/41 (4.88%)  1/43 (2.33%)  1/30 (3.33%)  1/31 (3.23%)  2/25 (8.00%)  0/26 (0.00%)  0/40 (0.00%) 
Hypothyroidism * 1  1/41 (2.44%)  2/43 (4.65%)  2/30 (6.67%)  2/31 (6.45%)  1/25 (4.00%)  0/26 (0.00%)  0/40 (0.00%) 
Eye disorders               
Dry eye * 1  3/41 (7.32%)  0/43 (0.00%)  2/30 (6.67%)  2/31 (6.45%)  1/25 (4.00%)  0/26 (0.00%)  1/40 (2.50%) 
Gastrointestinal disorders               
Abdominal pain upper * 1  1/41 (2.44%)  1/43 (2.33%)  1/30 (3.33%)  0/31 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/40 (2.50%) 
Dry mouth * 1  2/41 (4.88%)  2/43 (4.65%)  2/30 (6.67%)  1/31 (3.23%)  0/25 (0.00%)  0/26 (0.00%)  1/40 (2.50%) 
Dyspepsia * 1  2/41 (4.88%)  1/43 (2.33%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  3/26 (11.54%)  2/40 (5.00%) 
Gastrointestinal symptoms (diarrhea, bloating, gas) * 1 [1]  14/41 (34.15%)  9/43 (20.93%)  12/30 (40.00%)  11/31 (35.48%)  1/25 (4.00%)  6/26 (23.08%)  4/40 (10.00%) 
Nausea * 1  11/41 (26.83%)  10/43 (23.26%)  5/30 (16.67%)  8/31 (25.81%)  7/25 (28.00%)  4/26 (15.38%)  5/40 (12.50%) 
Oral pain * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/40 (0.00%) 
Vomiting * 1  4/41 (9.76%)  2/43 (4.65%)  3/30 (10.00%)  1/31 (3.23%)  2/25 (8.00%)  2/26 (7.69%)  2/40 (5.00%) 
General disorders               
Asthenia * 1  3/41 (7.32%)  1/43 (2.33%)  1/30 (3.33%)  0/31 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/40 (2.50%) 
Fatigue * 1  18/41 (43.90%)  22/43 (51.16%)  15/30 (50.00%)  8/31 (25.81%)  10/25 (40.00%)  12/26 (46.15%)  6/40 (15.00%) 
Feeling abnormal * 1  3/41 (7.32%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Flu-like symptoms (fever, chills, headache, aches/pains) * 1 [1]  37/41 (90.24%)  32/43 (74.42%)  23/30 (76.67%)  24/31 (77.42%)  16/25 (64.00%)  21/26 (80.77%)  28/40 (70.00%) 
Infections and infestations               
Ear infection * 1  1/41 (2.44%)  1/43 (2.33%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/40 (0.00%) 
Nasopharyngitis * 1  2/41 (4.88%)  2/43 (4.65%)  2/30 (6.67%)  3/31 (9.68%)  0/25 (0.00%)  3/26 (11.54%)  1/40 (2.50%) 
Tooth infection * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  2/40 (5.00%) 
Upper respiratory tract infection * 1  0/41 (0.00%)  2/43 (4.65%)  2/30 (6.67%)  0/31 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/40 (2.50%) 
Urinary tract infection * 1  0/41 (0.00%)  4/43 (9.30%)  0/30 (0.00%)  2/31 (6.45%)  0/25 (0.00%)  1/26 (3.85%)  1/40 (2.50%) 
Injury, poisoning and procedural complications               
Skin laceration * 1  0/41 (0.00%)  0/43 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  0/25 (0.00%)  0/26 (0.00%)  0/40 (0.00%) 
Investigations               
Haemoglobin decreased * 1  3/41 (7.32%)  2/43 (4.65%)  0/30 (0.00%)  0/31 (0.00%)  1/25 (4.00%)  3/26 (11.54%)  0/40 (0.00%) 
Weight decreased * 1  3/41 (7.32%)  2/43 (4.65%)  2/30 (6.67%)  3/31 (9.68%)  2/25 (8.00%)  2/26 (7.69%)  0/40 (0.00%) 
Metabolism and nutrition disorders               
Decreased appetite * 1  8/41 (19.51%)  5/43 (11.63%)  4/30 (13.33%)  3/31 (9.68%)  4/25 (16.00%)  6/26 (23.08%)  5/40 (12.50%) 
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  2/41 (4.88%)  4/43 (9.30%)  2/30 (6.67%)  1/31 (3.23%)  0/25 (0.00%)  2/26 (7.69%)  1/40 (2.50%) 
Back pain * 1  2/41 (4.88%)  2/43 (4.65%)  3/30 (10.00%)  1/31 (3.23%)  0/25 (0.00%)  0/26 (0.00%)  1/40 (2.50%) 
Myalgia * 1  5/41 (12.20%)  2/43 (4.65%)  2/30 (6.67%)  1/31 (3.23%)  1/25 (4.00%)  1/26 (3.85%)  0/40 (0.00%) 
Nervous system disorders               
Disturbance in attention * 1  0/41 (0.00%)  3/43 (6.98%)  0/30 (0.00%)  0/31 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Dizziness * 1  6/41 (14.63%)  7/43 (16.28%)  3/30 (10.00%)  5/31 (16.13%)  1/25 (4.00%)  3/26 (11.54%)  2/40 (5.00%) 
Dysgeusia * 1  1/41 (2.44%)  2/43 (4.65%)  2/30 (6.67%)  0/31 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  1/40 (2.50%) 
Headache * 1  5/41 (12.20%)  1/43 (2.33%)  7/30 (23.33%)  0/31 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  2/40 (5.00%) 
Lethargy * 1  0/41 (0.00%)  2/43 (4.65%)  0/30 (0.00%)  3/31 (9.68%)  3/25 (12.00%)  0/26 (0.00%)  3/40 (7.50%) 
Syncope * 1  1/41 (2.44%)  1/43 (2.33%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  2/26 (7.69%)  0/40 (0.00%) 
Psychiatric disorders               
Emotional/mental (depression, anxiety, irritability, forgetfulness, confusion, anger) * 1 [1]  21/41 (51.22%)  25/43 (58.14%)  15/30 (50.00%)  17/31 (54.84%)  11/25 (44.00%)  15/26 (57.69%)  13/40 (32.50%) 
Insomnia * 1  16/41 (39.02%)  18/43 (41.86%)  10/30 (33.33%)  6/31 (19.35%)  4/25 (16.00%)  11/26 (42.31%)  13/40 (32.50%) 
Respiratory, thoracic and mediastinal disorders               
Cough * 1  6/41 (14.63%)  4/43 (9.30%)  7/30 (23.33%)  3/31 (9.68%)  3/25 (12.00%)  2/26 (7.69%)  4/40 (10.00%) 
Dyspnoea * 1  9/41 (21.95%)  6/43 (13.95%)  6/30 (20.00%)  4/31 (12.90%)  3/25 (12.00%)  3/26 (11.54%)  1/40 (2.50%) 
Epistaxis * 1  1/41 (2.44%)  1/43 (2.33%)  3/30 (10.00%)  0/31 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  2/40 (5.00%) 
Oropharyngeal pain * 1  3/41 (7.32%)  2/43 (4.65%)  6/30 (20.00%)  0/31 (0.00%)  2/25 (8.00%)  2/26 (7.69%)  1/40 (2.50%) 
Respiratory tract congestion * 1  0/41 (0.00%)  1/43 (2.33%)  2/30 (6.67%)  1/31 (3.23%)  1/25 (4.00%)  0/26 (0.00%)  0/40 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia * 1  4/41 (9.76%)  9/43 (20.93%)  8/30 (26.67%)  1/31 (3.23%)  4/25 (16.00%)  4/26 (15.38%)  0/40 (0.00%) 
Dry skin * 1  1/41 (2.44%)  1/43 (2.33%)  4/30 (13.33%)  1/31 (3.23%)  2/25 (8.00%)  1/26 (3.85%)  0/40 (0.00%) 
Hyperhidrosis * 1  0/41 (0.00%)  0/43 (0.00%)  1/30 (3.33%)  1/31 (3.23%)  2/25 (8.00%)  2/26 (7.69%)  1/40 (2.50%) 
Skin (injection site reactions, rashes, pruritus) * 1 [1]  24/41 (58.54%)  24/43 (55.81%)  20/30 (66.67%)  16/31 (51.61%)  12/25 (48.00%)  18/26 (69.23%)  16/40 (40.00%) 
Vascular disorders               
Hot flush * 1  3/41 (7.32%)  0/43 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
Hypertension * 1  1/41 (2.44%)  0/43 (0.00%)  2/30 (6.67%)  1/31 (3.23%)  0/25 (0.00%)  1/26 (3.85%)  0/40 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
[1]
This was reported as ‘AE cluster’ i.e. combination of multiple AEs and not as separate AE PTs.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00483938     History of Changes
Other Study ID Numbers: ML21035
First Submitted: June 7, 2007
First Posted: June 8, 2007
Results First Submitted: November 25, 2016
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017