A Study of Pegylated Interferon Alfa-2a and Lamivudine in... | NCT01095835

NCT01095835

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEG-IFN48	Experimental	Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks.	Drug: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg
PEG-IFN96	Experimental	Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN treatment (total 96 weeks of treatment).	Drug: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg Drug: Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg
PEG-IFN+LAM96	Experimental	Treatment with PEG-IFN and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN treatment (total 96 weeks of treatment).	Drug: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg Drug: Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg Drug: Lamivudine (LAM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg	Drug	PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.	PEG-IFN+LAM96

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period	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.	At the end of the 48-week follow-up period at Week 144

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving the Combined Response at the End of Treatment	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.	At end of treatment at Week 48 or 96 depending on the study arm

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants With ALT Normalization		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
Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22859496	Derived	Lampertico P, Vigano M, Di Costanzo GG, Sagnelli E, Fasano M, Di Marco V, Boninsegna S, Farci P, Fargion S, Giuberti T, Iannacone C, Regep L, Massetto B, Facchetti F, Colombo M; PegBeLiver Study Group. Randomised study comparing 48 and 96 weeks peginterferon alpha-2a therapy in genotype D HBeAg-negative chronic hepatitis B. Gut. 2013 Feb;62(2):290-8. doi: 10.1136/gutjnl-2011-301430. Epub 2012 Aug 2.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	PEG-IFN48	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.
FG001	PEG-IFN96

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The ITT population included all participants randomized who received at least one dose of study medication.

Arm/Group Information

ID	Title	Description
BG000	PEG-IFN48	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.
BG001	PEG-IFN96	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.
BG002	PEG-IFN+LAM96	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00011.8 OG00125.0 OG00220.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.08													No	Superiority or Other

Secondary

Percentage of Participants Achieving the Combined Response at the End of Treatment

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.

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

At end of treatment at Week 48 or 96 depending on the study arm

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.
OG002	PEG-IFN+LAM96	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.

Secondary

Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up

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.

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

At the end of 24 weeks of follow-up at Week 120

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.
OG002	PEG-IFN+LAM96

Secondary

Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL

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.

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.

Secondary

Percentage of Participants Achieving Histological Response

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.

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

At the end of the 48-week follow-up period at Week 144

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.

Secondary

Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment

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.

Posted

Mean

Standard Deviation

IU/mL

At the end of treatment at Week 48 or 96 depending on the study arm

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.
OG002	PEG-IFN+LAM96	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.

Secondary

Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy

Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.

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.

Posted

Number

percentage of participants

At the end of the treatment period at Week 96

ID	Title	Description
OG000	PEG-IFN+LAM96	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.

Units	Counts
Participants	OG000

Other Pre-specified

Percentage of Participants With ALT Normalization

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.
OG002	PEG-IFN+LAM96	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.

Other Pre-specified

Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.
OG002	PEG-IFN+LAM96	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.

Other Pre-specified

Percentage of Participants With HBV-DNA Below Limit of Quantification

HBV-DNA limit < 6 IU/mL was defined as below quantification.

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.
OG002	PEG-IFN+LAM96	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.

Other Pre-specified

Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion

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.

The ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	PEG-IFN48	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.
OG001	PEG-IFN96	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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PEG-IFN48	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.	7	50	25	50
EG001	PEG-IFN96	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.	3	52	27	52
EG002	PEG-IFN + LAM96	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.	6	25	13	25

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected52 at risk EG0020 affected25 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Pyrexia	General disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Infected cyst	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk
Facial palsy	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Syncope	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected52 at risk EG0020 affected25 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0020 affected25 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected52 at risk EG0020 affected25 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk
Hypertensive crisis	Vascular disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0010 affected52 at risk EG0021 affected25 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0005 affected50 at risk EG0014 affected52 at risk EG0021 affected25 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected52 at risk EG0020 affected25 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG00012 affected50 at risk EG0019 affected52 at risk EG0023 affected25 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0006 affected50 at risk EG0016 affected52 at risk EG0021 affected25 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected52 at risk EG0022 affected25 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0004 affected50 at risk EG0014 affected52 at risk EG0023 affected25 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected50 at risk EG0014 affected52 at risk EG0021 affected25 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected52 at risk EG0022 affected25 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0014 affected52 at risk EG0022 affected25 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0005 affected50 at risk EG0012 affected52 at risk EG0022 affected25 at risk
Asthenia	General disorders	MedDRA (10.1)	Systematic Assessment	EG00017 affected50 at risk EG00119 affected52 at risk EG00211 affected25 at risk
Influenza like illness	General disorders	MedDRA (10.1)	Systematic Assessment	EG0009 affected50 at risk EG00110 affected52 at risk EG0024 affected25 at risk
Pyrexia	General disorders	MedDRA (10.1)	Systematic Assessment	EG00018 affected50 at risk EG00119 affected52 at risk EG0028 affected25 at risk
Pharyngitis	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0003 affected50 at risk EG0012 affected52 at risk EG0020 affected25 at risk
Tooth abscess	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0011 affected52 at risk EG0022 affected25 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0003 affected50 at risk EG0011 affected52 at risk EG0020 affected25 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.1)	Systematic Assessment	EG0002 affected50 at risk EG0014 affected52 at risk EG0022 affected25 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0010 affected52 at risk EG0022 affected25 at risk
Platelet count decreased	Investigations	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0014 affected52 at risk EG0020 affected25 at risk
White blood cell count decreased	Investigations	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected52 at risk EG0021 affected25 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected50 at risk EG0016 affected52 at risk EG0020 affected25 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0006 affected50 at risk EG0016 affected52 at risk EG0023 affected25 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0003 affected50 at risk EG0016 affected52 at risk EG0022 affected25 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0007 affected50 at risk EG0018 affected52 at risk EG0024 affected25 at risk
Headache	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG00013 affected50 at risk EG0018 affected52 at risk EG0027 affected25 at risk
Sciatica	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0013 affected52 at risk EG0020 affected25 at risk
Anxiety	Psychiatric disorders	MedDRA (10.1)	Systematic Assessment	EG0004 affected50 at risk EG0015 affected52 at risk EG0022 affected25 at risk
Insomnia	Psychiatric disorders	MedDRA (10.1)	Systematic Assessment	EG0004 affected50 at risk EG0010 affected52 at risk EG0022 affected25 at risk
Irritability	Psychiatric disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected52 at risk EG0022 affected25 at risk
Nervousness	Psychiatric disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected52 at risk EG0021 affected25 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0003 affected50 at risk EG0016 affected52 at risk EG0020 affected25 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0003 affected50 at risk EG0013 affected52 at risk EG0021 affected25 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0005 affected50 at risk EG0016 affected52 at risk EG0023 affected25 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected50 at risk EG0013 affected52 at risk EG0020 affected25 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0011 affected52 at risk EG0022 affected25 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected50 at risk EG0014 affected52 at risk EG0020 affected25 at risk

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C100416	peginterferon alfa-2a
D019259	Lamivudine

Ancestor Terms

ID	Term
D016047	Zalcitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D015224	Dideoxynucleosides

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.

Facility	Status	City	State	ZIP	Country	Contacts
		Bari	Apulia	70124	Italy