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Trial record 80 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

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ClinicalTrials.gov Identifier: NCT01095835
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : November 3, 2016
Last Update Posted : November 3, 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 B, Chronic
Interventions Drug: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg
Drug: Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg
Drug: Lamivudine (LAM)
Enrollment 131
Recruitment Details  
Pre-assignment Details The Intent-to-Treat (ITT) population (n=128) included all participants randomized who received at least one dose of study medication. Three enrolled participants (total enrolled n=131) did not receive any study medication and were therefore excluded from the ITT population.The ITT population is reported in the Participant Flow.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48. Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96. Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Period Title: Overall Study
Started 51 52 25
Completed 41 40 17
Not Completed 10 12 8
Reason Not Completed
Adverse Event             8             6             6
Lack of Efficacy             0             1             0
Physician Decision             0             0             1
Withdrawal by Subject             1             3             0
Non study compliance             0             0             1
Protocol Violation             1             2             0
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96 Total
Hide Arm/Group Description Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48. Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96. Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96. Total of all reporting groups
Overall Number of Baseline Participants 51 52 25 128
Hide Baseline Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 52 participants 25 participants 128 participants
45.1  (10.2) 44.1  (10.4) 45.6  (8.6) 44.6  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 25 participants 128 participants
Female
18
  35.3%
7
  13.5%
7
  28.0%
32
  25.0%
Male
33
  64.7%
45
  86.5%
18
  72.0%
96
  75.0%
1.Primary Outcome
Title Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period
Hide Description Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to <20,000 copies/mL (<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
Time Frame At the end of the 48-week follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
11.8 25.0 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN48, PEG-IFN96
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving the Combined Response at the End of Treatment
Hide Description Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.
Time Frame At end of treatment at Week 48 or 96 depending on the study arm
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
29.4 38.5 32.0
3.Secondary Outcome
Title Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up
Hide Description Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.
Time Frame At the end of 24 weeks of follow-up at Week 120
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
23.5 28.8 24.0
4.Secondary Outcome
Title Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
Hide Description Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off <2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
Time Frame At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
End of treatment 29.4 38.5 28.0
24 weeks of follow-up 21.6 26.9 20.0
48 weeks of follow-up 11.8 23.1 20.0
5.Secondary Outcome
Title Percentage of Participants Achieving Histological Response
Hide Description Histological response was defined as an improvement by >/= 2 in the Necroinflammatory Grading and/or by an improvement by >/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.
Time Frame At the end of the 48-week follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
13.7 5.8 8.0
6.Secondary Outcome
Title Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
Hide Description [Not Specified]
Time Frame At the end of treatment at Week 48 or 96 depending on the study arm
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Mean (Standard Deviation)
Unit of Measure: IU/mL
Baseline (n=51, 51, 25) 9642.6  (19756.4) 7229.8  (6459.0) 8981.0  (7728.5)
Change from baseline (n=44, 44, 20) -2801.1  (14691.2) -2282.1  (6007.1) -3121.2  (7128.9)
7.Secondary Outcome
Title Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy
Hide Description Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.
Time Frame At the end of the treatment period at Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.
Arm/Group Title PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: percentage of participants
0
8.Other Pre-specified Outcome
Title Percentage of Participants With ALT Normalization
Hide Description [Not Specified]
Time Frame At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
End of treatment 35.3 40.4 40.0
24 weeks of follow-up 45.1 46.2 40.0
48 weeks of follow-up 35.3 34.6 36.0
9.Other Pre-specified Outcome
Title Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL
Hide Description [Not Specified]
Time Frame At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
End of treatment: HBV-DNA < 3,400 IU/mL 60.8 67.3 76.0
24 weeks of follow-up: HBV-DNA < 3,400 IU/mL 23.5 30.8 24.0
48 weeks of follow-up: HBV-DNA < 3,400 IU/mL 11.8 30.8 20.0
End of treatment: HBV-DNA < 2,000 IU/mL 58.8 67.3 72.0
24 weeks of follow-up: HBV-DNA < 2,000 IU/mL 21.6 28.8 20.0
48 weeks of follow-up: HBV-DNA < 2,000 IU/mL 11.8 28.8 20.0
10.Other Pre-specified Outcome
Title Percentage of Participants With HBV-DNA Below Limit of Quantification
Hide Description HBV-DNA limit < 6 IU/mL was defined as below quantification.
Time Frame At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
End of treatment 17.6 30.8 24.0
24 weeks of follow-up 0.0 7.7 4.0
48 weeks of follow-up 2.0 7.7 8.0
11.Other Pre-specified Outcome
Title Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion
Hide Description This outcome measure presents percentage of participants with a combined response of HBsAg < 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.
Time Frame At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants randomized who received at least one dose of study medication.
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN+LAM96
Hide Arm/Group Description:
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
Overall Number of Participants Analyzed 51 52 25
Measure Type: Number
Unit of Measure: percentage of participants
End of treatment 2.0 3.8 0.0
24 weeks of follow-up 0.0 5.8 0.0
48 weeks of follow-up 0.0 7.7 0.0
Time Frame Up to 48 weeks after last study treatment dose (up to Week 144)
Adverse Event Reporting Description The Safety population included all participants randomized who received at least one dose of study medication and had at least one post-baseline safety assessment. In addition to participants excluded from the Intent-to-Treat (ITT) population, one participant in the ITT population did not perform a post-baseline safety assessment, and was therefore excluded from the safety population.
 
Arm/Group Title PEG-IFN48 PEG-IFN96 PEG-IFN + LAM96
Hide Arm/Group Description Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48. Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96. Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
All-Cause Mortality
PEG-IFN48 PEG-IFN96 PEG-IFN + LAM96
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN48 PEG-IFN96 PEG-IFN + LAM96
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/50 (14.00%)   3/52 (5.77%)   6/25 (24.00%) 
Blood and lymphatic system disorders       
Iron deficiency anaemia  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
Lymphadenopathy  1  0/50 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
General disorders       
Pyrexia  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
Hepatobiliary disorders       
Hepatitis acute  1  0/50 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Infections and infestations       
Cytomegalovirus infection  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
Infected cyst  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications       
Meniscus lesion  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Muscular weakness  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Nervous system disorders       
Facial palsy  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
Syncope  1  0/50 (0.00%)  1/52 (1.92%)  0/25 (0.00%) 
Guillain-Barre syndrome  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Interstitial lung disease  1  1/50 (2.00%)  0/52 (0.00%)  0/25 (0.00%) 
Vascular disorders       
Hypertensive crisis  1  0/50 (0.00%)  0/52 (0.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN48 PEG-IFN96 PEG-IFN + LAM96
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/50 (50.00%)   27/52 (51.92%)   13/25 (52.00%) 
Blood and lymphatic system disorders       
Anaemia  1  5/50 (10.00%)  4/52 (7.69%)  1/25 (4.00%) 
Leukopenia  1  1/50 (2.00%)  3/52 (5.77%)  0/25 (0.00%) 
Neutropenia  1  12/50 (24.00%)  9/52 (17.31%)  3/25 (12.00%) 
Thrombocytopenia  1  6/50 (12.00%)  6/52 (11.54%)  1/25 (4.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/50 (2.00%)  1/52 (1.92%)  2/25 (8.00%) 
Gastrointestinal disorders       
Abdominal pain  1  4/50 (8.00%)  4/52 (7.69%)  3/25 (12.00%) 
Abdominal pain upper  1  2/50 (4.00%)  4/52 (7.69%)  1/25 (4.00%) 
Diarrhoea  1  0/50 (0.00%)  3/52 (5.77%)  2/25 (8.00%) 
Dyspepsia  1  1/50 (2.00%)  4/52 (7.69%)  2/25 (8.00%) 
Nausea  1  5/50 (10.00%)  2/52 (3.85%)  2/25 (8.00%) 
General disorders       
Asthenia  1  17/50 (34.00%)  19/52 (36.54%)  11/25 (44.00%) 
Influenza like illness  1  9/50 (18.00%)  10/52 (19.23%)  4/25 (16.00%) 
Pyrexia  1  18/50 (36.00%)  19/52 (36.54%)  8/25 (32.00%) 
Infections and infestations       
Pharyngitis  1  3/50 (6.00%)  2/52 (3.85%)  0/25 (0.00%) 
Tooth abscess  1  0/50 (0.00%)  1/52 (1.92%)  2/25 (8.00%) 
Urinary tract infection  1  3/50 (6.00%)  1/52 (1.92%)  0/25 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  2/50 (4.00%)  4/52 (7.69%)  2/25 (8.00%) 
Blood thyroid stimulating hormone increased  1  1/50 (2.00%)  0/52 (0.00%)  2/25 (8.00%) 
Platelet count decreased  1  0/50 (0.00%)  4/52 (7.69%)  0/25 (0.00%) 
White blood cell count decreased  1  0/50 (0.00%)  3/52 (5.77%)  1/25 (4.00%) 
Metabolism and nutrition disorders       
Anorexia  1  2/50 (4.00%)  6/52 (11.54%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/50 (12.00%)  6/52 (11.54%)  3/25 (12.00%) 
Back pain  1  3/50 (6.00%)  6/52 (11.54%)  2/25 (8.00%) 
Myalgia  1  7/50 (14.00%)  8/52 (15.38%)  4/25 (16.00%) 
Nervous system disorders       
Headache  1  13/50 (26.00%)  8/52 (15.38%)  7/25 (28.00%) 
Sciatica  1  1/50 (2.00%)  3/52 (5.77%)  0/25 (0.00%) 
Psychiatric disorders       
Anxiety  1  4/50 (8.00%)  5/52 (9.62%)  2/25 (8.00%) 
Insomnia  1  4/50 (8.00%)  0/52 (0.00%)  2/25 (8.00%) 
Irritability  1  0/50 (0.00%)  3/52 (5.77%)  2/25 (8.00%) 
Nervousness  1  0/50 (0.00%)  3/52 (5.77%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/50 (6.00%)  6/52 (11.54%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  3/50 (6.00%)  3/52 (5.77%)  1/25 (4.00%) 
Pruritus  1  5/50 (10.00%)  6/52 (11.54%)  3/25 (12.00%) 
Psoriasis  1  0/50 (0.00%)  3/52 (5.77%)  0/25 (0.00%) 
Urticaria  1  1/50 (2.00%)  1/52 (1.92%)  2/25 (8.00%) 
Vascular disorders       
Hypertension  1  1/50 (2.00%)  4/52 (7.69%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
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
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01095835     History of Changes
Other Study ID Numbers: ML18253
First Submitted: March 26, 2010
First Posted: March 30, 2010
Results First Submitted: September 15, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016