Not provided
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Study ABI-H0731-203 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies.
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The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-H0731 + ETV | Active Comparator | Participants with cHBV will receive ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks |
|
| ABI-H0731 + ETV + Peg-IFNα | Experimental | Participants with cHBV will receive ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks |
|
| ETV + Peg-IFNα | Active Comparator | Participants with cHBV will receive ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H0731 | Drug | Participants will receive ABI-H0731 300 mg tablets orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event | Up to 60 weeks | |
| Number of Participants With Premature Discontinuation of Treatment | Up to 60 weeks | |
| Number of Participants With a Laboratory Abnormality | Up to 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in HBV pgRNA | Baseline and at pre-specified time points up to 60 weeks | |
| Mean Change From Baseline HBV DNA | Baseline and at pre-specified time points up to 60 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Current or prior treatment for CHB with
Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV) hepatitis C virus (HCV), hepatitis E virus (HEV), or hepatitis D virus (HDV)
Females who are lactating, or wish to become pregnant during the course of the study
History or evidence of advanced liver disease or hepatic decompensation at any time prior to, or at the time of Screening
History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
Clinically significant psychiatric disease, including severe depression, history of suicidal ideation or suicide attempt
Clinically significant cardiac disease including poorly controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than cHBV; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment; seizure disorders requiring treatment; ongoing infection or other medical conditions requiring frequent medical management; or pharmacologic or surgical treatment that, in the opinion of the Investigator or the Sponsor, makes the subject unsuitable for study participation
History of hepatocellular carcinoma (HCC)
History of malignancy other than HCC unless the subject's malignancy has been in complete remission off chemotherapy and without additional medical or surgical interventions during the 3 years before Screening
History or presence at Screening of electrocardiogram (ECG) abnormalities deemed clinically significant, in the opinion of the Investigator
History of hypersensitivity or idiosyncratic reaction to any components or excipients of the investigational drug
History of any significant food or drug-related allergic reactions such as, anaphylaxis or Stevens-Johnson syndrome
Exclusionary laboratory results at Screening:
Subjects receiving prohibited concomitant medications or medications that should be avoided within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the first dose of study drug (Day 1) and for the duration of the study period. Please refer to Exclusion Criterion #1 for criteria regarding liver protecting and/or ALT lowering agents
Participation in another clinical study of any non-HBV-related drug or device whereby the last investigational drug/device administration is within 60 days or 5 half-lives prior to the first study drug administration (Day 1), whichever is longer.
Subjects who have received, in the previous 4 weeks, a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or high-dose steroids, or other immunosuppressants).
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| Name | Affiliation | Role |
|---|---|---|
| Grace Wang, MD | Assembly Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China | ||
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | ABI-H0731 + Entecavir (ETV) | Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily |
| FG001 | ABI-H0731 + ETV + Pegylated-interferon Alpha (Peg-IFNα) | Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
| FG002 | ETV + Peg-IFNα | Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABI-H0731 + ETV | Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With an Adverse Event | Posted | Count of Participants | Participants | Up to 60 weeks |
|
Baseline up to 28 days after the last study drug administration (excluding ETV), up to 60 weeks.
Adverse events were regularly assessed through scheduled investigator assessment and laboratory testing.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABI-H0731 + ETV | Participants with cHBV received ABI-H0731 with ETV for 48 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Platelet Count Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
Study ABI-H0731-203 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. As a result, not all subjects completed Week 48 and some outcome measures were impacted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Assembly BioSciences Inc. | 415-366-5172 | psalstrand@assemblybio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 9, 2023 | Jun 21, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ETV | Drug | Participants will receive ETV 0.5 mg tablets orally once daily |
|
|
| Peg-IFNα | Biological | Participants will receive Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
|
|
| Mean Change From Baseline in HBeAg |
| Baseline and at pre-specified time points up to 60 weeks |
| Mean Change From Baseline in HBcrAg | Baseline and at pre-specified time points up to 60 weeks |
| Mean Change From Baseline in HBsAg | Baseline and at pre-specified time points up to 60 weeks |
| Number of Participants With Normalized Alanine Aminotransferase (ALT) | Baseline and at pre-specified time points up to 60 weeks |
| Plasma Concentration of ABI-H0731 | Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24 |
| Incidence of HBV Variants With Reduced Susceptibility to ABI-H0731 | Pre-specified time points up to 60 weeks |
| Beijing YouAn Hospital, Capital Medical University |
| Beijing |
| Beijing Municipality |
| 100069 |
| China |
| Nanfang Hospital, First Military Medical University | Guangzhou | Guangdong | 510000 | China |
| 8th Affiliated Hospital of Guangzhou | Guangzhou | Guangdong | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| Jilin University First Hospital | Changchun | Jilin | 130021 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China |
| The first affiliated Hospital, College of Zhejiang University | Hangzhou | Zhejiang | China |
| Adverse Event |
|
| Protocol Violation |
|
| Pregnancy |
|
| Virology rebounded |
|
| ABI-H0731 + ETV + Peg-IFNα |
Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
| BG002 | ETV + Peg-IFNα | Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Years positive for HBV | Some participants had an unknown number of years positive for HBV so they were not included in the analysis. | Mean | Standard Deviation | years |
|
| HBV Genotype | Count of Participants | Participants |
|
| HBV DNA (Log10 IU/mL) | Mean | Standard Deviation | Log 10 IU/mL |
|
| HBV pgRNA (Log10 U/mL) | Mean | Standard Deviation | Log10 U/mL |
|
| HBcrAg (Log10 kU/mL) | Mean | Standard Deviation | Log10 kU/mL |
|
| HBeAg (Log10 IU/mL) | Mean | Standard Deviation | Log10 IU/mL |
|
| HBsAg (Log10 IU/mL) | Mean | Standard Deviation | Log10 IU/mL |
|
| ALT (U/L) | Mean | Standard Deviation | U/L |
|
| OG002 | ETV + Peg-IFNα | Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated. ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly |
|
|
| Primary | Number of Participants With Premature Discontinuation of Treatment | Posted | Count of Participants | Participants | Up to 60 weeks |
|
|
|
| Primary | Number of Participants With a Laboratory Abnormality | Posted | Count of Participants | Participants | Up to 60 weeks |
|
|
|
| Secondary | Mean Change From Baseline in HBV pgRNA | Due to early termination of the study, not all subjects reached Week 48. | Posted | Mean | Standard Deviation | log10 U/mL | Baseline and at pre-specified time points up to 60 weeks |
|
|
|
| Secondary | Mean Change From Baseline HBV DNA | Due to early termination of the study, not all subjects reached Week 48. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline and at pre-specified time points up to 60 weeks |
|
|
|
| Secondary | Mean Change From Baseline in HBeAg | Due to early termination of the study, not all subjects reached Week 48. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline and at pre-specified time points up to 60 weeks |
|
|
|
| Secondary | Mean Change From Baseline in HBcrAg | Due to early termination of the study, not all subjects reached Week 48. | Posted | Mean | Standard Deviation | log10 kU/mL | Baseline and at pre-specified time points up to 60 weeks |
|
|
|
| Secondary | Mean Change From Baseline in HBsAg | Due to early termination of the study, not all subjects reached Week 48. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline and at pre-specified time points up to 60 weeks |
|
|
|
| Secondary | Number of Participants With Normalized Alanine Aminotransferase (ALT) | Due to early termination of the study, data were not collected or analyzed for secondary outcomes. | Posted | Baseline and at pre-specified time points up to 60 weeks |
|
|
| Secondary | Plasma Concentration of ABI-H0731 | No ABI-H0731 PK data were collected from the ETV + Peg-IFNα group until Week 24 when they started receiving ABI-H0731. | Posted | Mean | Standard Deviation | ng/mL | Predose on Day 1, Week 4, and Week 24 and at pre-specified time points postdose up to Week 24 |
|
|
|
| Secondary | Incidence of HBV Variants With Reduced Susceptibility to ABI-H0731 | No cases met the criteria for resistance analysis. | Posted | Pre-specified time points up to 60 weeks |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 14 |
| 20 |
| EG001 | ABI-H0731 + ETV + Peg-IFNα | Participants with cHBV received ABI-H0731 with ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ABI-H0731: Participants received ABI-H0731 300 mg tablets orally once daily ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly | 0 | 17 | 1 | 17 | 17 | 17 |
| EG002 | ETV + Peg-IFNα | Participants with cHBV received ETV and Peg-IFNα for 24 weeks, followed by ABI-H0731 with ETV for 24 weeks, followed by ETV alone for 12 weeks or until the study was early terminated ETV: Participants received ETV 0.5 mg tablets orally once daily Peg-IFNα: Participants received Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly | 0 | 17 | 0 | 17 | 17 | 17 |
| Pyrexia | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Calcium Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Glomerular Filtration Rate Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Amylase Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Abnormal Loss of Weight | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Androgenetic Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Animal Bite | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Phosphorus Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Decreased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Blood Urine Present | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Epigastric Discomfort | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Functional Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Glucose Tolerance Impaired | Metabolism and nutrition disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Helicobacter Infection | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Hepatic Pain | Hepatobiliary disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Mean Cell Haemoglobin Concentration Increased | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Mouth Ulceration | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Pain In Extremity | General disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Pericoronitis | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Seborrhoeic Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Skin Injury | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
|
| Thrombocytopenic Purpura | Blood and lymphatic system disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Urinary Occult Blood Positive | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Urinary Sediment Present | Investigations | MedDRA Version 23.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Uterine Haemorrhage | Reproductive system and breast disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Vaginal Infection | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
| Viral Rash | Infections and infestations | MedDRA Version 23.1 | Systematic Assessment |
|
Not provided
| 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 |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Genotype B |
|
| Genotype C |
|
| Genotype D |
|
| Other Genotype |
|
| Week 2 |
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| Week 12 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
|
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| Day 1, 2 to 4 hours postdose |
|
|
| Week 2, 30 min to 2 hours postdose |
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| Week 4, predose |
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| Week 8, 30 min to 2 hours postdose |
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| Week 12, 30 min to 2 hours postdose |
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| Week 16, 4 to 6 hours postdose |
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| Week 20, 4 to 6 hours postdose |
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| Week 24, predose |
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| Week 24, 30 min to 2 hours postdose |
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