Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pe... | NCT04980482

NCT04980482

Status Module

Sponsor/Collaborators Module

Oversight Module

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
Cohort A, Group 1	Experimental	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.	Drug: AB-729 Drug: Peg-IFNα-2a
Cohort A, Group 2	Experimental	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.	Drug: AB-729 Drug: Peg-IFNα-2a
Cohort B, Group 1	Experimental	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.	Drug: AB-729 Drug: Peg-IFNα-2a
Cohort B, Group 2	Experimental	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.	Drug: AB-729 Drug: Peg-IFNα-2a

Name	Type	Description	Arm Group Labels	Other Names
AB-729	Drug	subcutaneous injection	Cohort A, Group 1 Cohort A, Group 2 Cohort B, Group 1 Cohort B, Group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a		Up to 124 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point		Up to 124 weeks
Proportion of Subjects With HBsAb Seroconversion at Each Timepoint		Up to 124 weeks

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Liver Health		Chandler	Arizona	85224	United States
Arizona Liver Health

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lead-In Treatment	24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
FG001	Cohort A1	AB-729 60 mg SC every 8 weeks x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 17, 2022	Apr 1, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Arm/Group Information

ID	Title	Description
BG000	Cohort A1	AB-729 60 mg SC every 8 weeks, x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
BG001	Cohort A2	NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
BG002	Cohort B1	AB-729 60 mg SC every 8 weeks, x1 dose + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
BG003	Cohort B2	NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
BG004	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

Years

Mean

Full Range

Years

Title

Denominators

Categories

Title	Measurements
	BG00045.5(31 to 55) BG00141.5(32 to 53) BG00248.6(41 to 56) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG00010 BG0019 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG0000 BG0010 BG002

Weight (kg)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00064.52± 15.764 BG00179.45± 16.653 BG002

Height (cm)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000164.64± 9.690 BG001170.78± 6.164 BG002

Body Mass Index (kg/m2)

Mean

Standard Deviation

kg/m2

Title

Denominators

Categories

Title	Measurements
	BG00023.59± 4.360 BG00127.10± 4.739 BG002

Baseline ALT (U/L)

Mean

Standard Deviation

U/L

Title

Denominators

Categories

Title	Measurements
	BG00019.2± 6.07 BG00125.3± 9.81 BG002

Baseline HBsAg (Log10 IU/mL)

Mean

Standard Deviation

Log10 IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0003.020± 0.4499 BG0012.914± 0.5156 BG002

Baseline HBV DNA (IU/mL)

Mean

Standard Deviation

IU/mL

Title

Denominators

Categories

Title	Measurements
	BG0002.3± 1.97 BG0011.3± 1.11 BG002

Background Nucleos(t)ide Analog

Count of Participants

Participants

Title

Denominators

Categories

Tenofovir disoproxil fumarate

Title	Measurements
	BG0005 BG0012 BG002

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

The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a

Safety Lead-in Population

Posted

Count of Participants

Participants

Up to 124 weeks

ID	Title	Description
OG000	Lead-In Treatment	24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy
OG001	Cohort A1	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
OG002	Cohort A2	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.
OG003	Cohort B1	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.
OG004	Cohort B2	AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Units	Counts
Participants	OG00043 OG00112 OG00213 OG003

Title

Denominators

Categories

Frequency of TEAEs

Title	Measurements
TEAEs	OG00023 OG00111 OG00211 OG003

Secondary

Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point

Not Posted

Up to 124 weeks

Participants

Secondary

Proportion of Subjects With HBsAb Seroconversion at Each Timepoint

Not Posted

Up to 124 weeks

Participants

Secondary

Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up

Not Posted

Up to 76 weeks

Participants

Secondary

Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria

Not Posted

Up to 124 weeks

Participants

Secondary

Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Clinical Relapse Criteria. Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Viral Relapse Criteria

Not Posted

Up to 124 weeks

Participants

Secondary

Post-dose Plasma Concentrations of AB-729 Anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at Selected Timepoints

Not Posted

Up to 40 weeks

Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lead-In Treatment	24 week lead-in period of imdusiran 60 mg SC every 8 weeks (Q8W) x4 doses added to ongoing SOC NA therapy	43	0	43	23	43
EG001	Cohort A1	AB-729 60 mg SC every 8 weeks, x2 doses + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.	12	1	12	11	12
EG002	Cohort A2	NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.	13	0	13	11	13
EG003	Cohort B1	AB-729 60 mg SC every 8 weeks, x1 dose + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.	8	0	8	8	8
EG004	Cohort B2	NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.	10	1	10	9	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Ureterolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	Grade 2, Moderate intensity, Not Related	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG0030 affected8 at risk EG004
Bilateral Chronic Rhinonasal Sinusitis with Polyposis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	Grade 2, Recovered, Not related	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Nasal Septum Deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	Grade 2, Recovered, Not Related	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG0030 affected8 at risk EG0040 affected10 at risk
Iron Deficiency Anemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Anal Fissure	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Peptic Ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Tooth Impacted	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Pyrexia	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0015 affected12 at risk EG0022 affected13 at risk EG003
Injection Site Erythema	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0014 affected12 at risk EG0021 affected13 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected12 at risk EG0021 affected13 at risk EG003
Influenza like illness	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Chills	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Injection Site Bruising	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Injection Site Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Injection Site Reaction	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Chest Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Injection Site Discoloration	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Injection Site Irritation	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Injection Site Pruritus	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Mucosal Dryness	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Swelling	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Thirst	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Hepatic Steatosis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0005 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0004 affected43 at risk EG0012 affected12 at risk EG0022 affected13 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Gingivitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Laryngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Pelvic Inflammatory Disease	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0003 affected43 at risk EG0013 affected12 at risk EG0020 affected13 at risk EG003
Neutrophil Count Decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected12 at risk EG0023 affected13 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Sar-Cov-2 Test Positive	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Weight Decreased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Blood Thyroid Stimulating Hormone Increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Liver Function Test Increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Transaminase Increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Hyperlipidemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Muscle Spasm	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0021 affected13 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Depression	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0022 affected13 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0012 affected12 at risk EG0020 affected13 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Tonsillar Cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0013 affected12 at risk EG0021 affected13 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0012 affected12 at risk EG0021 affected13 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0021 affected13 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0021 affected13 at risk EG003
Skin Swelling	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0021 affected13 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Hand Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Non-Scarring Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0011 affected12 at risk EG0020 affected13 at risk EG003
Palmer Erythema	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Endodontic Procedure	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Varicose Vein	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0021 affected13 at risk EG003
Dental Caries	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Abcess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Blood Creatine Phosphokinase Increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Anxiety Disorder	Psychiatric disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Renal Cyst	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Chronic Rhinosinusitis with Nasal Polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Nasal Septum Deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected43 at risk EG0010 affected12 at risk EG0020 affected13 at risk EG003

ID	Term
D019694	Hepatitis B, Chronic
D006509	Hepatitis B
D006505	Hepatitis

Ancestor Terms

ID	Term
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
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0042 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk

EG0041 affected10 at risk

EG0040 affected10 at risk