A Study of Early Immunologic Response in Asian Patients W... | NCT00962871

Status Module

Label	Type	Intervention Names
1	Active Comparator	Drug: tenofovir
2	Experimental	Drug: peginterferon alfa-2a [Pegasys] Drug: tenofovir
3	Experimental	Drug: peginterferon alfa-2a [Pegasys]
4	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
peginterferon alfa-2a [Pegasys]	Drug	360 micrograms sc/week for 2 weeks	2 3

Measure	Description	Time Frame
Mean Change From Baseline in Viral Quantitative e Antibody	An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.	Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

Measure	Description	Time Frame
Mean Change From Baseline in HBV-DNA log10	An acute virologic response was determined by change from baseline in HBV-DNA log10.	Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Early Changes in Viral Sequence Associated With Viral Suppression

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90036	United States

PubMed Identifier	Type	Citation	Retractions
32049318	Derived	Mehrotra A, D'Angelo JA, Romney-Vanterpool A, Chu T, Bertoletti A, Janssen HLA, Gehring AJ. IFN-alpha Suppresses Myeloid Cytokine Production, Impairing IL-12 Production and the Ability to Support T-Cell Proliferation. J Infect Dis. 2020 Jun 16;222(1):148-157. doi: 10.1093/infdis/jiaa064.
25406369	Derived

Label	URL
This report describes the early effects of IFNα treatment on immune and viral biomarkers in HBeAg+ CHB patients. The results show that PegIFNα-induced innate immune activation directly benefits from the suppression of HBV replication.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tenofovir 300 mg	Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
FG001	Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Tenofovir 300 mg	Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
BG001	Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg	Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
BG002	PEG-IFN Alfa-2a 360 μg	Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
BG003	Delayed Treatment	Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0006 BG0016 BG00212 BG0036 BG00430

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

Mean Change From Baseline in Viral Quantitative e Antibody

An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.

All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.

Posted

Mean

Standard Deviation

Cut-off index (C.O.I.)

Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

ID	Title	Description
OG000	Tenofovir 300 mg	Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
OG001	Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg	Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
OG002	PEG-IFN Alfa-2a 360 μg	Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
OG003	Delayed Treatment	Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.

Units	Counts
Participants	OG0006 OG0016 OG00212 OG003

Title

Denominators

Categories

Day 1

Title	Measurements
	OG0000.07± 0.162 OG0010.15± 0.234 OG0020.02± 0.063 OG003

Secondary

Mean Change From Baseline in HBV-DNA log10

An acute virologic response was determined by change from baseline in HBV-DNA log10.

All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.

Posted

Mean

Standard Deviation

IU/mL

Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

ID	Title	Description
OG000	Tenofovir 300 mg	Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
OG001	Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg	Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
OG002	PEG-IFN Alfa-2a 360 μg	Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.

Secondary

Early Changes in Viral Sequence Associated With Viral Suppression

Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.

Not Posted

Day 1, 5, 14, Week 4 and 6

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tenofovir 300 mg	Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.	6	6	6
EG001	Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg	Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.	6	6	6
EG002	PEG-IFN Alfa-2a 360 μg	Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.	12	12	12
EG003	Delayed Treatment	Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.	6	6	6

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0015 affected6 at risk EG0029 affected12 at risk EG0033 affected6 at risk
Fatigue	General disorders	MedDRA 15.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected6 at risk EG0024 affected12 at risk EG003
Influenza like illness	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Chills	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected12 at risk EG003
Feeling cold	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Injection site erythema	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Injection site rash	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Injection site reaction	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Thirst	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Xerosis	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0015 affected6 at risk EG0026 affected12 at risk EG003
Lethargy	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0023 affected12 at risk EG003
Tremor	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0025 affected12 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0022 affected12 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected12 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0020 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Breath odour	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0023 affected12 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected12 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0023 affected12 at risk EG003
Polydipsia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Eye pain	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected12 at risk EG003
Dry eye	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Rhinitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Wolff-parkinson-white syndrome	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected12 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected12 at risk EG003
Hot flush	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected12 at risk EG003

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

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds