Hepatitis BPhase 3NCT01368497
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
A Phase 3 study testing Entecavir and peginterferon in people with Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entecavir and peginterferon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2012to 23 Dec 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Texas Southwestern
Dallas, Texas, 75235
University of Minnesota
Minneapolis, Minnesota, 55455
University of California San Francisco Medical Center
San Francisco, California, 94143
Seattle Children's Hospital
Seattle, Washington, 98015
Saint Louis Children's Medical Center
St Louis, Missouri, 63104
About this study
Official title: Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN)
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
Read the detailed description
This single arm treatment study was conducted by the pediatric centers within the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK)-sponsored Hepatitis B Research Network (HBRN). Children age 3-<18 years with immunotolerant chronic hepatitis B (CHB) infection who fulfilled the entry criteria received entecavir as monotherapy for 8 weeks and then combination therapy with entecavir and pegylated interferon by weekly subcutaneous injection until week 48. Children were to be followed for 48 weeks after discontinuation of therapy (week 96 for those who completed 48 weeks of treatment).
Assessment was undertaken at baseline, weeks 4, 8, 10, 12, 14, \& 16, then every 4 weeks until week 48, and then 4, 8, 12, 24,36, and 48 weeks following treatment discontinuation corresponding to weeks 52, 56, 60, 72, 84 and 96 for those who received treatment for 48 weeks. Blood work was drawn to measure markers of viral and liver disease status and for research biospecimen banking.
Participants were to receive therapy until week 48 and enter 48 weeks of follow-up thereafter. Participants who experienced a sustained elevation of alanine aminotransferase (ALT) were eligible to receive treatment as recommended by their hepatologist and continued to complete the study protocol.
- Conditions
- Hepatitis B
- Being tested
- Entecavir and peginterferon
- Keywords
- Hepatitis B, HBV
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir and peginterferonDrug
Also called PEGASYS, peginterferon alfa 2a, Baraclude
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).
| Study group | Role | What they receive |
|---|---|---|
| Entecavir and peginterferon | Experimental | Entecavir for 8 weeks followed by 40 weeks of both entecavir and peginterferon Receives: Drug: Entecavir and peginterferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Secondary outcomes (21)
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBeAg Seroconversion
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBeAg Seroconversion
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBsAg Seroconversion
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBsAg Seroconversion
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Measured: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA < 20 IU/mL
Measured: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA < 20 IU/mL
Measured: End of follow-up (up to 96 weeks)
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.
Measured: End of treatment (up to 48 weeks)
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.
Measured: End of treatment (up to 48 weeks)
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.
Measured: End of follow-up (up to 96 weeks)
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.
Measured: End of treatment (up to 48 weeks)
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.
Measured: End of follow-up (up to 96 weeks)
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.
Measured: End of treatment (up to 48 weeks)
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.
Measured: End of follow-up (up to 96 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startSep 2012
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Averell Sherker, MD, Study chair, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ed Doo, MD, Study chair, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Kathleen Schwarz, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368497
- Sponsor's protocol ID
- DK082864 HBRN IT Peds Trial
- Other IDs
- U01DK082916, U01DK082864, U01DK082874, U01DK082944, U01DK082843, U01DK082871, UL1TR000423, UL1TR000004
- Status last verified
- May 2022
- First submitted
- 6 Jun 2011
- Last updated
- 26 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be sent to the NIDDK-supported data repository.
Publications
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.
PubMed 24318082
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN)
- ClinicalTrials.gov ID
- NCT01368497
- Acronym / sponsor ID
- DK082864 HBRN IT Peds Trial
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, HBV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2012
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
Detailed description
This single arm treatment study was conducted by the pediatric centers within the National Institute of Diabetes Digestive and Kidney Diseases (NIDDK)-sponsored Hepatitis B Research Network (HBRN). Children age 3-<18 years with immunotolerant chronic hepatitis B (CHB) infection who fulfilled the entry criteria received entecavir as monotherapy for 8 weeks and then combination therapy with entecavir and pegylated interferon by weekly subcutaneous injection until week 48. Children were to be followed for 48 weeks after discontinuation of therapy (week 96 for those who completed 48 weeks of treatment).
Assessment was undertaken at baseline, weeks 4, 8, 10, 12, 14, \& 16, then every 4 weeks until week 48, and then 4, 8, 12, 24,36, and 48 weeks following treatment discontinuation corresponding to weeks 52, 56, 60, 72, 84 and 96 for those who received treatment for 48 weeks. Blood work was drawn to measure markers of viral and liver disease status and for research biospecimen banking.
Participants were to receive therapy until week 48 and enter 48 weeks of follow-up thereafter. Participants who experienced a sustained elevation of alanine aminotransferase (ALT) were eligible to receive treatment as recommended by their hepatologist and continued to complete the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entecavir and peginterferon | Experimental | Drug: Entecavir and peginterferonEntecavir for 8 weeks followed by 40 weeks of both entecavir and peginterferon |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entecavir and peginterferonAlso: PEGASYS, peginterferon alfa 2a, BaracludeEntecavir 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). | Drug | Entecavir and peginterferon |
Primary outcome
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)
Time frame: End of follow-up (up to 96 weeks)
Incidence of Adverse Events (AEs) Per Person-Year
Time frame: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
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.
Incidence of Serious Adverse Events (SAEs) Per Person-Year
Time frame: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
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.
21 secondary outcomes
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBeAg Seroconversion
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBeAg Seroconversion
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBsAg Seroconversion
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBsAg Seroconversion
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA ≤1000 IU/mL
Time frame: End of follow-up (up to 96 weeks)
Proportion of Participants With HBV DNA < 20 IU/mL
Time frame: End of treatment (up to 48 weeks)
Proportion of Participants With HBV DNA < 20 IU/mL
Time frame: End of follow-up (up to 96 weeks)
Proportion Without Detectable Antiviral Drug-resistance HBV Mutations
Time frame: End of treatment (up to 48 weeks)
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Time frame: End of treatment (up to 48 weeks)
Growth Measures: Z-scores Weight, Height, and Body Mass Index
Time frame: End of follow-up (up to 96 weeks)
Tanner Stages of Physical Growth
Time frame: End of treatment (up to 48 weeks)
Tanner Stages of Physical Growth
Time frame: End of follow-up (up to 96 weeks)
Tanner Stages of Pubic Hair Growth
Time frame: End of treatment (up to 48 weeks)
Tanner Stages of Pubic Hair Growth
Time frame: End of follow-up (up to 96 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24318082Morris 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.
- Individual participant dataSharing planned: Yes. All data will be sent to the NIDDK-supported data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Averell Sherker, MD study chair
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ed Doo, MD study chair
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kathleen Schwarz, MD principal investigator
Johns Hopkins University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entecavir and peginterferon in people with Hepatitis B, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: End of follow-up (up to 96 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01368497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.