Entecavir/Pegylated Interferon in Immune Tolerant Childre... | NCT01368497

ID	Type	Description	Link
U01DK082916	U.S. NIH Grant/Contract		View source
U01DK082864	U.S. NIH Grant/Contract		View source
U01DK082874	U.S. NIH Grant/Contract		View source
U01DK082944	U.S. NIH Grant/Contract		View source
U01DK082843	U.S. NIH Grant/Contract		View source
U01DK082871	U.S. NIH Grant/Contract		View source
UL1TR000423	U.S. NIH Grant/Contract		View source
UL1TR000004	U.S. NIH Grant/Contract		View source
A-DK-3002-001	Other Identifier	Interagency agreement with NIDDK

Status Module

Description Module

Label	Type	Description	Intervention Names
Entecavir and peginterferon	Experimental	Entecavir for 8 weeks followed by 40 weeks of both entecavir and peginterferon	Drug: Entecavir and peginterferon

Name	Type	Description	Arm Group Labels	Other Names
Entecavir and peginterferon	Drug	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 µg/1.73m2 subcutaneously once weekly for 40 weeks beginning 8 weeks after entecavir monotherapy).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)		End of follow-up (up to 96 weeks)
Incidence of Adverse Events (AEs) Per Person-Year	The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.	From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Incidence of Serious Adverse Events (SAEs) Per Person-Year	The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.	From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss		End of treatment (up to 48 weeks)
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss		End of follow-up (up to 96 weeks)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Enrolled in & completed the baseline evaluation in NCT01263600 OR completed necessary components of NCT01263600 baseline evaluation by the end of the baseline visit.
3 to <18 years at time of randomization (day 0).
Documented chronic Hepatitis B virus (HBV) infection as evidenced by detection of hepatitis B surface antigen (HBsAg) in serum for ≥ 24 weeks prior to baseline OR positive HBsAg and negative anti-Hepatitis B core (HBc) immunoglobulin (IgM) within 24 weeks of baseline visit.
Presence of hepatitis B e-antigen (HBeAg) in serum at the last screening visit within 6 weeks of baseline visit.
Serum HBV DNA level >10^7 IU/mL on at least 2 occasions at least 12 weeks apart during the 52 weeks before baseline visit. The HBV DNA levels must be within 6 weeks of baseline visit.
ALT ≤60 U/l in males or ≤40 U/l in females, measured on at least 2 occasions, at screening (within 6 weeks prior to baseline visit) & at least 12 weeks prior to the screening visit & within the 52 weeks prior to baseline visit.
Compensated liver disease, with normal total bilirubin (except if Gilbert's syndrome), direct bilirubin ≤0.5 mg/dL, International Normalized Ratio (INR) ≤1.5, and serum albumin ≥3.5 g/dL.
Creatinine clearance 90 ml/min.
Absence of hepatocellular carcinoma on liver ultrasound in the past 48 weeks.

Exclusion criteria:

Presence of infection with Hepatitis C virus (HCV)-RNA or anti-HCV, anti-Hepatitis D virus (HDV), or HIV at screening.
Presence of another cause of liver disease or hepatocellular cancer (HCC) (serum alpha-fetoprotein >50ng /ml).
Evidence of decompensated liver disease (Childs B-C).
History or other evidence of a medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
Females who are pregnant or breastfeeding.
Adolescent females unwilling or unable to use an acceptable method of contraception if sexually active during the treatment period.
Children currently breastfeeding while their mother is taking lamivudine, or those who were exposed to lamivudine for ≥24 weeks via maternal lamivudine treatment during pregnancy and/or while breastfeeding.
Previous liver or other organ transplantation including engrafted bone marrow transplant.
Hematological abnormalities during the screening period that contraindicate full dosing with study drugs, e.g absolute neutrophil count < 1.5 x 10^9 cells/L or platelet count < 120 x 10^9 cells/L.
Known allergy to study drugs; peginterferon alfa-2a or entecavir.
Treatment with systemic acyclovir or famciclovir within the previous 6 months.
Need for ongoing use of any antivirals with activity against HBV during the course of the study or history of receiving treatment for HBV.
Any use of illegal drugs OR use of alcoholic beverages which in the opinion of a study physician is sufficient to prevent adequate compliance with study procedures or increase the risk of pancreatitis or hepatotoxicity.
History of immunologically mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).
History or other evidence of bleeding from esophageal varices or consistent with decompensated liver disease.
History or other evidence of chronic pulmonary disease associated with functional limitation.
History of significant cardiovascular diseases.
History of a severe seizure disorder or current anticonvulsant use.
History or other evidence of severe retinopathy.
History of thyroid disease poorly controlled on prescribed medications. Participants with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded.
Concomitant use or use during ≤ 6 months prior to the first dose of study drug of anti-neoplastic, immunosuppressive, nephrotoxic or hepatotoxic medication, methadone, theophylline or medications that may affect renal excretion or hepatic metabolism are not permitted.
Concomitant use of complementary or alternative medications purported to have antiviral activity.
A participant may not be co-enrolled in another clinical trial where an investigational drug is administered.
Any other condition or situation that in the opinion of a study physician would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.

Name	Affiliation	Role
Averell Sherker, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Study Chair
Ed Doo, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Study Chair
Kathleen Schwarz, MD	Johns Hopkins University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco Medical Center		San Francisco	California	94143	United States

PubMed Identifier	Type	Citation	Retractions
24318082	Background	Morris NM, Udry JR. Validation of a self-administered instrument to assess stage of adolescent development. J Youth Adolesc. 1980 Jun;9(3):271-80. doi: 10.1007/BF02088471.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Aug 19, 2013

ID	Title	Description
BG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

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

Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Title

Denominators

Categories

Title	Measurements
	OG000.033(.004 to .115)

Primary

Incidence of Adverse Events (AEs) Per Person-Year

The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.

Posted

Number

95% Confidence Interval

AEs per person-year of observation

From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Primary

Incidence of Serious Adverse Events (SAEs) Per Person-Year

The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.

Posted

Number

95% Confidence Interval

SAEs per person-year of observation

From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Secondary

Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBeAg Seroconversion

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBeAg Seroconversion

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBsAg Seroconversion

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBsAg Seroconversion

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBV DNA ≤1000 IU/mL

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBV DNA ≤1000 IU/mL

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBV DNA < 20 IU/mL

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion of Participants With HBV DNA < 20 IU/mL

Posted

Number

95% Confidence Interval

Proportion of participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG00060

Secondary

Proportion Without Detectable Antiviral Drug-resistance HBV Mutations

HBV drug resistance variant testing was performed at the CDC laboratory. The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing. Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.

Posted

Number

95% Confidence Interval

Proportion of participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Secondary

Growth Measures: Z-scores Weight, Height, and Body Mass Index

A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.

Posted

Mean

95% Confidence Interval

Z-score

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Secondary

Growth Measures: Z-scores Weight, Height, and Body Mass Index

Posted

Mean

95% Confidence Interval

Z-score

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Secondary

Tanner Stages of Physical Growth

The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth.

Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia.

Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage.

There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Posted

Count of Participants

Participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts

Secondary

Tanner Stages of Physical Growth

There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Posted

Count of Participants

Participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts

Secondary

Tanner Stages of Pubic Hair Growth

The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth.

Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity.

There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Posted

Count of Participants

Participants

End of treatment (up to 48 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Secondary

Tanner Stages of Pubic Hair Growth

There is no "better" or "worse" outcome. They are self-assessed descriptive measures of physical growth.

Posted

Count of Participants

Participants

End of follow-up (up to 96 weeks)

ID	Title	Description
OG000	Entecavir and Peginterferon	Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 μg/1.73m^2 subcutaneously times the participant's body surface area once weekly during weeks 9-48 of treatment. After treatment discontinuation, follow-up off treatment for 48 weeks.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Small splenic mass	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Low absolute neutrophil count	Blood and lymphatic system disorders	Systematic Assessment	EG00013 events10 affected60 at risk
Low absolute neutrophil count and platelets	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected60 at risk
Syncope Episode	Cardiac disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Fluid in left ear	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Thyroid-stimulating hormone (TSH) elevation	Endocrine disorders	Systematic Assessment	EG0002 events2 affected60 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Bilateral conjunctivitis	Eye disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Blurry vision	Eye disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Decreased visual acuity	Eye disorders	Systematic Assessment	EG0002 events1 affected60 at risk
Upset stomach	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Elective extraction of four primary teeth	General disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Nauseous and achy	General disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Mild nose bleed	General disorders	Systematic Assessment	EG0002 events1 affected60 at risk
Sore throat	General disorders	Systematic Assessment	EG0001 events1 affected60 at risk
ALT or AST elevation	Hepatobiliary disorders	Systematic Assessment	EG0006 events6 affected60 at risk
Total bilirubin elevation	Hepatobiliary disorders	Systematic Assessment	EG0002 events1 affected60 at risk
Bilateral periocular dermatitis	Immune system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Bilateral rash and swelling of feet	Immune system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Hives	Immune system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Strep throat	Infections and infestations	Systematic Assessment	EG0004 events4 affected60 at risk
Ear infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected60 at risk
Infection from tooth extraction	Infections and infestations	Systematic Assessment	EG0001 events1 affected60 at risk
Keratitis and uveitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected60 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected60 at risk
Sinus infection	Infections and infestations	Systematic Assessment	EG0005 events4 affected60 at risk
Sore throat and fever	Infections and infestations	Systematic Assessment	EG0001 events1 affected60 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected60 at risk
Creatinine elevation	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Creatine kinase elevation	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Ptosis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Febrile seizure	Nervous system disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Short temper or slight agitation	Psychiatric disorders	Systematic Assessment	EG0002 events1 affected60 at risk
Occult blood in urine	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Menstrual cramping	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected60 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected60 at risk
Skin rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected60 at risk
Skin lesions	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected60 at risk
Abscess gum from tooth extraction	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected60 at risk

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
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases