An Observational Cohort Study in Patients With Chronic He... | NCT01011738

Label	Type	Description	Intervention Names
Cohort

Measure	Description	Time Frame
Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance	Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) 'Negative' or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis "as observed").	Up to 276 Weeks
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants	The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.	Up to 276 Weeks
Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants	The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.

Measure	Description	Time Frame
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter	A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.	Up to 276 Weeks

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Lkh-Univ. Klinikum Graz		Graz		8036	Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Klinische Abt. Für Gaströnterologie & Hepatologie

ID	Title	Description
FG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance

Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) 'Negative' or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis "as observed").

mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Units	Counts
Participants	OG000844 OG001872

Title

Denominators

Categories

Analysis A, n= 844, 872

Title	Measurements
	OG0002(1 to 3) OG0015(3 to 6)

Analysis B, n= 328, 394

Title	Measurements
	OG000

Secondary

Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter

A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Primary

Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants

The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.

Secondary

Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants

HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) 'POSITIVE' or (ii) a quantitative result considered 'positive' in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL.

Abbreviations for pt=post-treatment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.

Secondary

Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants

A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants

A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA ≥ 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered.

Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.

Primary

Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants

The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Percentage of Participants With Hepatitis B Surface Antigen Seroconversion

Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) 'POSITIVE' or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Quantitative Hepatitis B Surface Antigen

Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.

Posted

Mean

Standard Deviation

Log10 IU/mL

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Percentage of Participants With Normalization of Alanine Transaminase

A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.

mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status

ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.

Posted

Mean

Standard Deviation

Ratio

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation

Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).

Posted

Number

Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis

Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.

Posted

Number

Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Number of Participants With Serious Adverse Drug Reactions

A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect.

Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).

Posted

Number

Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Number of Participants With Non-Serious Adverse Drug Reactions

Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.

Posted

Number

Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Number of Participants With Adverse Events and Serious Adverse Events

An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.

Posted

Number

Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Secondary

Number of Deaths During Observation Period

The clinical endpoint of deaths due to any cause during observation period is presented.

Safety population was defined to include participants with informed consent who received at least one dose of peginterferon alfa-2a and had at least one post-baseline safety assessment (any assessment after baseline).

Posted

Number

Participants

Up to 276 Weeks

ID	Title	Description
OG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
OG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0004 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0013 affected890 at risk EG0020 affected48 at risk
Angina Pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Angina Unstable	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Arrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Dermoid Cyst	Congenital, familial and genetic disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Basedow's Disease	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Hypothyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Ascites	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Localised Intraabdominal Fluid Collection	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Pancreatitis Haemorrhagic	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Asthenia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Chest Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Hyperthermia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Multi-Organ Failure	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Pyrexia	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Biliary Colic	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0021 affected48 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Gallbladder Polyp	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Hepatocellular Injury	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Hepatorenal Syndrome	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Jaundice	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Liver Disorder	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0003 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Appendicitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0013 affected890 at risk EG0020 affected48 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Cholangitis Infective	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Hepatitis B	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
HIV Infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Malaria	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Meningitis Viral	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Peritonitis Bacterial	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Pneumonia Haemophilus	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Pyelonephritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Salmonellosis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Septic Shock	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Tularaemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Open Fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0004 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Alpha 1 Foetoprotein Increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Thyroid Function Test Abnormal	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Transaminases Increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0002 affected863 at risk EG0013 affected890 at risk EG0020 affected48 at risk
Tumour Marker Increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0010 affected890 at risk EG0021 affected48 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Psoriatic Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Hepatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0004 affected863 at risk EG0018 affected890 at risk EG0020 affected48 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Metastases To Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Coma	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Coma Hepatic	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0012 affected890 at risk EG0020 affected48 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Ruptured Cerebral Aneurysm	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Major Depression	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Panic Attack	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Renal Colic	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Hepatic Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Aortic Stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 affected863 at risk EG0010 affected890 at risk EG0020 affected48 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk
Venous Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 affected863 at risk EG0011 affected890 at risk EG0020 affected48 at risk

ID	Title	Description
BG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
BG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
BG002	HBeAg Status Unknown	This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
BG003	Total	Total of all reporting groups

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	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HBeAg Positive	This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.	47	863	522	863
EG001	HBeAg Negative	This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.	63	890	562	890
EG002	HBeAg Status Unknown	This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.	2	48	30	48