Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 97 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01368497
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : July 3, 2018
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis B
Intervention Drug: Entecavir and peginterferon
Enrollment 60
Recruitment Details Sixty children were enrolled at 7 pediatric clinical sites in the United States and Canada between 9/20/2012 and 12/30/2014.
Pre-assignment Details  
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 60
End of Treatment 60 [1]
Completed 58
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
[1]
Five discontinued study drugs early and completed the follow-up period per protocol.
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
10.9
(3.4 to 17.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
45
  75.0%
Male
15
  25.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
White
1
   1.7%
Black/African-American
3
   5.0%
Asian
54
  90.0%
Mixed
2
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Canada
12
  20.0%
United States
48
  80.0%
HBV DNA  
Median (Full Range)
Unit of measure:  Log10 IU/mL
Number Analyzed 60 participants
8.2
(7.5 to 9.1)
1.Primary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
2.Primary Outcome
Title Incidence of Adverse Events (AEs) Per Person-Year
Hide Description 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.
Time Frame From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AEs per person-year of observation
End of treatment (Up to 48 weeks)
1.13
(0.88 to 1.46)
End of follow-up (Up to 96 weeks)
0.70
(0.56 to 0.87)
3.Primary Outcome
Title Incidence of Serious Adverse Events (SAEs) Per Person-Year
Hide Description 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.
Time Frame From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: SAEs per person-year of observation
End of treatment (Up to 48 weeks)
0 [1] 
(NA to NA)
End of follow-up (Up to 96 weeks)
0.01
(0.00 to 0.07)
[1]
95% Confidence Interval (CI) around 0 not calculated
4.Secondary Outcome
Title Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.050
(.010 to .139)
5.Secondary Outcome
Title Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
6.Secondary Outcome
Title Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
7.Secondary Outcome
Title Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
8.Secondary Outcome
Title Proportion of Participants With HBeAg Seroconversion
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
9.Secondary Outcome
Title Proportion of Participants With HBeAg Seroconversion
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
10.Secondary Outcome
Title Proportion of Participants With HBsAg Seroconversion
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
11.Secondary Outcome
Title Proportion of Participants With HBsAg Seroconversion
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
12.Secondary Outcome
Title Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.350
(.231 to .484)
13.Secondary Outcome
Title Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.650
(.516 to .769)
14.Secondary Outcome
Title Proportion of Participants With HBV DNA ≤1000 IU/mL
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.750
(.621 to .853)
15.Secondary Outcome
Title Proportion of Participants With HBV DNA ≤1000 IU/mL
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
16.Secondary Outcome
Title Proportion of Participants With HBV DNA < 20 IU/mL
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.233
(.134 to .360)
17.Secondary Outcome
Title Proportion of Participants With HBV DNA < 20 IU/mL
Hide Description [Not Specified]
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
.033
(.004 to .115)
18.Secondary Outcome
Title Absence of Detectable Antiviral Drug-resistance HBV Mutations
Hide Description [Not Specified]
Time Frame End of treatment (up to 48 weeks)
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Growth Measures: Z-scores Weight, Height, and Body Mass Index
Hide Description 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.
Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Mean (95% Confidence Interval)
Unit of Measure: Z-score
Z-score weight
-0.48
(-0.94 to -0.10)
Z-score height
-0.41
(-0.78 to -0.04)
Z-score BMI
-0.37
(-0.82 to 0.01)
20.Secondary Outcome
Title Growth Measures: Z-scores Weight, Height, and Body Mass Index
Hide Description 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.
Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Mean (95% Confidence Interval)
Unit of Measure: Z-score
Z-score weight
-0.34
(-0.81 to 0.02)
Z-score height
-0.45
(-0.88 to -0.04)
Z-score BMI
-0.14
(-0.54 to 0.21)
21.Secondary Outcome
Title Tanner Stages of Physical Growth
Hide Description

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.

Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
I
12
  20.0%
II
3
   5.0%
III
12
  20.0%
IV
8
  13.3%
V
7
  11.7%
Missing
18
  30.0%
22.Secondary Outcome
Title Tanner Stages of Physical Growth
Hide Description

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.

Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
I
14
  23.3%
II
5
   8.3%
III
9
  15.0%
IV
8
  13.3%
V
12
  20.0%
Missing
12
  20.0%
23.Secondary Outcome
Title Tanner Stages of Pubic Hair Growth
Hide Description

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.

Time Frame End of treatment (up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
I
15
  25.0%
II
4
   6.7%
III
4
   6.7%
IV
12
  20.0%
V
7
  11.7%
Missing
18
  30.0%
24.Secondary Outcome
Title Tanner Stages of Pubic Hair Growth
Hide Description

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.

Time Frame End of follow-up (up to 96 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
I
16
  26.7%
II
6
  10.0%
III
5
   8.3%
IV
9
  15.0%
V
12
  20.0%
Missing
12
  20.0%
Time Frame Study entry (consent) to the end of follow-up (48 weeks following the end of treatment).
Adverse Event Reporting Description

Expected symptoms/signs or common side effects of study meds need not be reported (these are Adverse Effects). These are a guide for recording adverse events, which are at the discretion of the investigator.

  1. Symptom or event requiring discontinuation of study medication.
  2. New symptom or event requiring a written prescription for treatment.
  3. New symptom or event resulting in a referral to another provider.
  4. Grade 3 or 4 event per the NCI Common Toxicity Criteria.
 
Arm/Group Title Entecavir and Peginterferon
Hide Arm/Group Description 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.
All-Cause Mortality
Entecavir and Peginterferon
Affected / at Risk (%)
Total   0/60 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Entecavir and Peginterferon
Affected / at Risk (%) # Events
Total   1/60 (1.67%)    
Nervous system disorders   
Myasthenia gravis   1/60 (1.67%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Entecavir and Peginterferon
Affected / at Risk (%) # Events
Total   37/60 (61.67%)    
Blood and lymphatic system disorders   
Small splenic mass   1/60 (1.67%)  1
Low absolute neutrophil count   10/60 (16.67%)  13
Low absolute neutrophil count and platelets   1/60 (1.67%)  1
Neutropenia   2/60 (3.33%)  2
Cardiac disorders   
Syncope Episode   1/60 (1.67%)  1
Ear and labyrinth disorders   
Fluid in left ear   1/60 (1.67%)  1
Endocrine disorders   
Thyroid-stimulating hormone (TSH) elevation   2/60 (3.33%)  2
Hyperthyroidism   1/60 (1.67%)  1
Hypothyroidism   1/60 (1.67%)  1
Eye disorders   
Bilateral conjunctivitis   1/60 (1.67%)  1
Blurry vision   1/60 (1.67%)  1
Decreased visual acuity   1/60 (1.67%)  2
Gastrointestinal disorders   
Upset stomach   1/60 (1.67%)  1
General disorders   
Elective extraction of four primary teeth   1/60 (1.67%)  1
Nauseous and achy   1/60 (1.67%)  1
Mild nose bleed   1/60 (1.67%)  2
Sore throat   1/60 (1.67%)  1
Hepatobiliary disorders   
ALT or AST elevation   6/60 (10.00%)  6
Total bilirubin elevation   1/60 (1.67%)  2
Immune system disorders   
Bilateral periocular dermatitis   1/60 (1.67%)  1
Bilateral rash and swelling of feet   1/60 (1.67%)  1
Hives   1/60 (1.67%)  1
Infections and infestations   
Strep throat   4/60 (6.67%)  4
Ear infection   1/60 (1.67%)  1
Infection from tooth extraction   1/60 (1.67%)  1
Keratitis and uveitis   1/60 (1.67%)  1
Pneumonia   1/60 (1.67%)  1
Sinus infection   4/60 (6.67%)  5
Sore throat and fever   1/60 (1.67%)  1
Upper respiratory infection   1/60 (1.67%)  1
Metabolism and nutrition disorders   
Creatinine elevation   1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders   
Creatine kinase elevation   1/60 (1.67%)  1
Nervous system disorders   
Ptosis   1/60 (1.67%)  1
Febrile seizure   1/60 (1.67%)  1
Psychiatric disorders   
Short temper or slight agitation   1/60 (1.67%)  2
Renal and urinary disorders   
Occult blood in urine   1/60 (1.67%)  1
Reproductive system and breast disorders   
Menstrual cramping   1/60 (1.67%)  1
Skin and subcutaneous tissue disorders   
Acne   2/60 (3.33%)  2
Alopecia   2/60 (3.33%)  2
Skin rash   2/60 (3.33%)  2
Skin lesions   1/60 (1.67%)  1
Abscess gum from tooth extraction   1/60 (1.67%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Belle
Organization: University of Pittsburgh
Phone: 412-624-3758
EMail: belle@edc.pitt.edu
Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01368497     History of Changes
Other Study ID Numbers: DK082864 HBRN IT Peds Trial
U01DK082916 ( U.S. NIH Grant/Contract )
U01DK082864 ( U.S. NIH Grant/Contract )
U01DK082874 ( U.S. NIH Grant/Contract )
U01DK082944 ( U.S. NIH Grant/Contract )
U01DK082843 ( U.S. NIH Grant/Contract )
U01DK082871 ( U.S. NIH Grant/Contract )
UL1TR000423 ( U.S. NIH Grant/Contract )
UL1TR000004 ( U.S. NIH Grant/Contract )
A-DK-3002-001 ( Other Identifier: Interagency agreement with NIDDK )
First Submitted: June 6, 2011
First Posted: June 8, 2011
Results First Submitted: March 13, 2018
Results First Posted: July 3, 2018
Last Update Posted: September 5, 2019