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Trial record 1 of 382 for:    IFNA2 AND RBV AND genotype
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Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus

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ClinicalTrials.gov Identifier: NCT02761629
Recruitment Status : Completed
First Posted : May 4, 2016
Results First Posted : August 16, 2016
Last Update Posted : August 16, 2016
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: Peg-Interferon Alpha-2A
Drug: Ribavirin
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg. Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Period Title: Overall Study
Started 90 90
Treated 82 86
Completed 63 58
Not Completed 27 32
Reason Not Completed
Adverse Event/Intercurrent Illness             7             5
Insufficient Therapeutic Response             2             7
Failure to Return             2             4
Did not Cooperate/Refused Treatment             2             4
Protocol Violation             2             2
Withdrawal by Subject             0             3
Other             0             2
Lost to Follow-up             4             1
Randomized But Not Treated             8             4
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks Total
Hide Arm/Group Description Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. Total of all reporting groups
Overall Number of Baseline Participants 80 85 165
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis population included all randomized participants who receive at least one dose of any study medication and have at least one post-baseline efficacy assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 85 participants 165 participants
42.3  (7.9) 42.2  (8.4) 42.3  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 85 participants 165 participants
Female
31
  38.8%
26
  30.6%
57
  34.5%
Male
49
  61.3%
59
  69.4%
108
  65.5%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR)
Hide Description SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.
Time Frame 24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis population
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 80 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.8
(15.0 to 34.6)
36.5
(26.3 to 47.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks, Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0536
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
-0.01 to 26.6
Estimation Comments Exact 95% confidence interval was from the binomial distribution for response rate.
2.Secondary Outcome
Title Percentage of Participants With Undetectable HCV RNA
Hide Description HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for ‘Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks’ arm and Week 72 for ‘Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks’ arm).
Time Frame For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, and 48; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, and 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable for this outcome at specified time-point; for each arm, respectively.
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 73 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4 (n=73, 83)
2.7
(0.3 to 9.6)
12.0
(5.9 to 21.0)
Week 12 (n=73, 81)
23.3
(14.2 to 34.7)
28.4
(18.9 to 39.5)
Week 24 (n=73, 78)
52.1
(40.0 to 63.9)
53.8
(42.2 to 65.2)
Week 48 (n=68, 71)
55.9
(43.3 to 67.9)
64.8
(52.5 to 75.8)
Week 72 (n=0, 65)
NA [1] 
(NA to NA)
56.9
(44.0 to 69.2)
[1]
Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for this arm); hence, no data reported for Week 72 for this arm.
3.Secondary Outcome
Title Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A
Hide Description HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.
Time Frame 12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 84 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 80 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.8
(15.0 to 34.6)
36.5
(26.3 to 47.6)
4.Secondary Outcome
Title Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment
Hide Description SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm).
Time Frame 24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment.
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 38 37
Measure Type: Number
Unit of Measure: percentage of participants
52.6 24.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks, Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0175
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Serum Human Immunodeficiency Virus (HIV) RNA Levels
Hide Description HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Time Frame For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and "n" = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively.
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 12 23
Mean (Standard Deviation)
Unit of Measure: Log10 copies per milliliter
Baseline (n=12, 23) 4.23  (0.82) 4.64  (0.74)
Week 4 (n=6, 16) 3.94  (0.38) 3.98  (0.69)
Week 24 (n=9, 20) 3.96  (0.36) 4.21  (0.72)
Week 48 (n=11, 17) 4.02  (0.65) 4.41  (0.75)
Week 72 (n=10, 9) 4.08  (0.78) 4.51  (0.85)
Week 96 (n=0, 13) NA [1]   (NA) 4.22  (0.85)
[1]
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
6.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96
Hide Description Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Time Frame For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable at specified time-point; for each arm, respectively.
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 78 81
Mean (Standard Deviation)
Unit of Measure: Cells per cubic millimeter (cells/mm^3)
Baseline (n=78, 81) 578.7  (277.1) 546.2  (278.8)
Change at Week 4 (n=69, 74) -148.2  (197.5) -88.0  (154.9)
Change at Week 12 (n=68, 75) -185.4  (192.7) -164.5  (193.9)
Change at Week 24 (n=69, 68) -206.7  (217.0) -178.4  (207.5)
Change at Week 48 (n=61, 67) -209.4  (242.4) -196.4  (226.4)
Change at Week 72 (n=58, 55) 9.5  (188.9) -167.5  (235.8)
Change at Week 96 (n=0, 62) NA [1]   (NA) -15.1  (212.2)
[1]
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
7.Secondary Outcome
Title Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96
Hide Description Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Time Frame For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and "n" = participants who were evaluable at specified time-point; for each arm, respectively.
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 78 81
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline (n=78, 81) 0.67  (0.39) 0.68  (0.44)
Change at Week 4 (n=69, 74) 0.11  (0.42) 0.09  (0.21)
Change at Week 12 (n=68, 75) 0.22  (0.31) 0.20  (0.27)
Change at Week 24 (n=69, 68) 0.36  (0.51) 0.29  (0.30)
Change at Week 48 (n=61, 67) 0.43  (0.47) 0.30  (0.43)
Change at Week 72 (n=58, 55) 0.12  (0.41) 0.36  (0.43)
Change at Week 96 (n=0, 62) NA [1]   (NA) 0.09  (0.35)
[1]
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
8.Secondary Outcome
Title Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories
Hide Description ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).
Time Frame For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population: all randomized participants who receive >/=1 dose of any study medication and had >/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and “n” = participants who were evaluable at specified time-point; for each arm, respectively.
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description:
Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
Overall Number of Participants Analyzed 79 82
Measure Type: Number
Unit of Measure: percentage of participants
Week 4, NL (n=70, 78) 50.0 52.6
Week 4, >1-2 ULN (n=70, 78) 40.0 38.5
Week 4, >2-5 ULN (n=70, 78) 10.0 9.0
Week 4, >5-10 ULN (n=70, 78) 0.0 0.0
Week 4, >10 ULN (n=70, 78) 0.0 0.0
Week 12, NL (n=76, 77) 61.8 62.3
Week 12, >1-2 ULN (n=76, 77) 27.6 29.9
Week 12, >2-5 ULN (n=76, 77) 10.5 5.2
Week 12, >5-10 ULN (n=76, 77) 0.0 1.3
Week 12, >10 ULN (n=76, 77) 0.0 1.3
Week 24, NL (n=74, 74) 70.3 63.5
Week 24, >1-2 ULN (n=74, 74) 27.0 28.4
Week 24, >2-5 ULN (n=74, 74) 2.7 6.8
Week 24, >5-10 ULN (n=74, 74) 0.0 0.0
Week 24, >10 ULN (n=74, 74) 0.0 1.4
Week 48, NL (n=65, 71) 67.7 69.0
Week 48, >1-2 ULN (n=65, 71) 24.6 26.8
Week 48, >2-5 ULN (n=65, 71) 7.7 2.8
Week 48, >5-10 ULN (n=65, 71) 0.0 1.4
Week 48, >10 ULN (n=65, 71) 0.0 0.0
Week 72, NL (n=59, 61) 52.5 68.9
Week 72, >1-2 ULN (n=59, 61) 27.1 27.9
Week 72, >2-5 ULN (n=59, 61) 20.3 3.3
Week 72, >5-10 ULN (n=59, 61) 0.0 0.0
Week 72, >10 ULN (n=59, 61) 0.0 0.0
Week 96, NL (n=0, 62) NA [1]  50
Week 96, >1-2 ULN (n=0, 62) NA [1]  35.5
Week 96, >2-5 ULN (n=0, 62) NA [1]  12.9
Week 96, >5-10 ULN (n=0, 62) NA [1]  1.6
Week 96, >10 ULN (n=0, 62) NA [1]  0
[1]
Data for this outcome measure was to be reported up to 24 weeks after end of treatment (Week 72 for this arm); hence, no data reported for Week 96 for this arm.
Time Frame 96 weeks
Adverse Event Reporting Description Safety analysis population.
 
Arm/Group Title Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Hide Arm/Group Description Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg. Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
All-Cause Mortality
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   7/82 (8.54%)   12/86 (13.95%) 
Blood and lymphatic system disorders     
Anaemia not otherwise specified (NOS) * 1  0/82 (0.00%)  1/86 (1.16%) 
Neutropenia * 1  0/82 (0.00%)  1/86 (1.16%) 
Cardiac disorders     
Pericardial effusion * 1  0/82 (0.00%)  1/86 (1.16%) 
Endocrine disorders     
Hypothyroidism * 1  1/82 (1.22%)  0/86 (0.00%) 
Eye disorders     
Erythema of eyelid * 1  0/82 (0.00%)  1/86 (1.16%) 
Gastrointestinal disorders     
Diarrhoea NOS * 1  1/82 (1.22%)  0/86 (0.00%) 
Mouth ulceration * 1  1/82 (1.22%)  0/86 (0.00%) 
General disorders     
Influenza like illness * 1  1/82 (1.22%)  0/86 (0.00%) 
Hepatobiliary disorders     
Cholecystitis NOS * 1  0/82 (0.00%)  1/86 (1.16%) 
Hepatic disorder NOS * 1  0/82 (0.00%)  1/86 (1.16%) 
Immune system disorders     
Drug hypersensitivity * 1  0/82 (0.00%)  1/86 (1.16%) 
Infections and infestations     
Pneumonia NOS * 1  1/82 (1.22%)  0/86 (0.00%) 
Postoperative infection * 1  1/82 (1.22%)  0/86 (0.00%) 
Respiratory tract infection NOS * 1  1/82 (1.22%)  1/86 (1.16%) 
Cytomegalovirus oesophagitis * 1  0/82 (0.00%)  1/86 (1.16%) 
Furuncle * 1  0/82 (0.00%)  1/86 (1.16%) 
Mycobacterial infection NOS * 1  0/82 (0.00%)  1/86 (1.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lip and/or oral cavity cancer NOS * 1  1/82 (1.22%)  0/86 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy NOS * 1  1/82 (1.22%)  0/86 (0.00%) 
Psychiatric disorders     
Depression * 1  1/82 (1.22%)  0/86 (0.00%) 
Irritability * 1  0/82 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders     
Renal failure acute * 1  1/82 (1.22%)  0/86 (0.00%) 
Reproductive system and breast disorders     
Vulvar dysplasia * 1  0/82 (0.00%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders     
Dermatitis bullous * 1  0/82 (0.00%)  1/86 (1.16%) 
Social circumstances     
Drug abuser NOS * 1  0/82 (0.00%)  1/86 (1.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   79/82 (96.34%)   81/86 (94.19%) 
Blood and lymphatic system disorders     
Anaemia NOS * 1  31/82 (37.80%)  25/86 (29.07%) 
Neutropenia * 1  13/82 (15.85%)  14/86 (16.28%) 
Gastrointestinal disorders     
Nausea * 1  21/82 (25.61%)  20/86 (23.26%) 
Diarrhoea NOS * 1  13/82 (15.85%)  16/86 (18.60%) 
Abdominal pain upper * 1  10/82 (12.20%)  8/86 (9.30%) 
Vomiting NOS * 1  9/82 (10.98%)  17/86 (19.77%) 
Dyspepsia * 1  5/82 (6.10%)  7/86 (8.14%) 
Abdominal pain NOS * 1  4/82 (4.88%)  9/86 (10.47%) 
General disorders     
Pyrexia * 1  30/82 (36.59%)  32/86 (37.21%) 
Fatigue * 1  26/82 (31.71%)  27/86 (31.40%) 
Asthenia * 1  23/82 (28.05%)  30/86 (34.88%) 
Influenza like illness * 1  13/82 (15.85%)  12/86 (13.95%) 
Malaise * 1  10/82 (12.20%)  8/86 (9.30%) 
Chest pain * 1  8/82 (9.76%)  6/86 (6.98%) 
Infections and infestations     
Influenza * 1  6/82 (7.32%)  7/86 (8.14%) 
Sinusitis NOS * 1  6/82 (7.32%)  7/86 (8.14%) 
Herpes simplex * 1  5/82 (6.10%)  3/86 (3.49%) 
Oral candidiasis * 1  4/82 (4.88%)  5/86 (5.81%) 
Investigations     
Weight decreased * 1  9/82 (10.98%)  8/86 (9.30%) 
Metabolism and nutrition disorders     
Anorexia * 1  25/82 (30.49%)  22/86 (25.58%) 
Appetite decreased NOS * 1  9/82 (10.98%)  14/86 (16.28%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  38/82 (46.34%)  33/86 (38.37%) 
Arthralgia * 1  7/82 (8.54%)  13/86 (15.12%) 
Back pain * 1  5/82 (6.10%)  9/86 (10.47%) 
Nervous system disorders     
Headache * 1  34/82 (41.46%)  41/86 (47.67%) 
Dizziness * 1  14/82 (17.07%)  8/86 (9.30%) 
Somnolence * 1  6/82 (7.32%)  8/86 (9.30%) 
Psychiatric disorders     
Depression * 1  16/82 (19.51%)  11/86 (12.79%) 
Irritability * 1  15/82 (18.29%)  13/86 (15.12%) 
Insomnia * 1  14/82 (17.07%)  23/86 (26.74%) 
Anxiety * 1  8/82 (9.76%)  9/86 (10.47%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  6/82 (7.32%)  15/86 (17.44%) 
Epistaxis * 1  5/82 (6.10%)  3/86 (3.49%) 
Pharyngolaryngeal pain * 1  3/82 (3.66%)  5/86 (5.81%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  9/82 (10.98%)  9/86 (10.47%) 
Pruritus * 1  6/82 (7.32%)  11/86 (12.79%) 
Dry skin * 1  1/82 (1.22%)  6/86 (6.98%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 4.0
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: Hoffman-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02761629     History of Changes
Other Study ID Numbers: ML18473
First Submitted: May 3, 2016
First Posted: May 4, 2016
Results First Submitted: July 5, 2016
Results First Posted: August 16, 2016
Last Update Posted: August 16, 2016