Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
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ClinicalTrials.gov Identifier: NCT01368497 |
Recruitment Status
:
Completed
First Posted
: June 8, 2011
Last Update Posted
: February 26, 2018
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | June 6, 2011 | |||||||||
First Posted Date ICMJE | June 8, 2011 | |||||||||
Last Update Posted Date | February 26, 2018 | |||||||||
Study Start Date ICMJE | September 2012 | |||||||||
Actual Primary Completion Date | December 23, 2016 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Hepatitis B surface antigen (HBsAg) loss and hepatitis b DNA levels ≤1000 IU/mL [ Time Frame: at week 96 ] | |||||||||
Change History | Complete list of historical versions of study NCT01368497 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||||||||
Original Other Outcome Measures ICMJE | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection | |||||||||
Official Title ICMJE | Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN) | |||||||||
Brief 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. | |||||||||
Detailed Description | This multicenter, randomized, controlled study will be 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 fulfill the entry criteria will receive entecavir as monotherapy for 8 weeks and then combination therapy with entecavir and pegylated interferon by weekly subcutaneous injection until week 48. Children will be followed for 96 weeks which is 48 weeks after discontinuation of therapy. Assessment will be undertaken at baseline, weeks 4, 8, 10, 12, 14, & 16, then every 4 weeks until week 48, and then at week 52, 56, 60, 72, 84 and 96. Data collected will describe baseline demographics, symptoms of liver disease, intercurrent illnesses, and findings on physical examination. Blood work will be drawn to measure markers of viral and liver disease status, assessment of drug adverse effects, and for research biospecimen banking. Participants will continue on therapy until week 48 and complete the full study follow-up protocol thereafter, including those who undergo seroconversion to anti-HBe or anti-HBs before reaching week 48. Participants who experience a sustained elevation of ALT will be eligible to receive treatment as recommended by their hepatologist and will continue to complete the study follow-up protocol. Participants who exhibit adverse effects of therapy will undergo dose adjustment or discontinuation of therapy as detailed in the protocol, and will continue to complete the study follow-up protocol. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase | Phase 3 | |||||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hepatitis B | |||||||||
Intervention ICMJE | Drug: 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/1.73m2 subcutaneously once weekly for 40 weeks beginning 8 weeks after entecavir monotherapy).
Other Name: PEGASYS, peginterferon alfa 2a, Baraclude |
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Study Arms | Experimental: Entecavir and peginterferon
Entecavir for 8 weeks and then combination therapy with entecavir and peginterferon 180 mcg/1.73m2 by weekly subcutaneous injection until week 48
Intervention: Drug: Entecavir and peginterferon |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
60 | |||||||||
Original Estimated Enrollment ICMJE |
250 | |||||||||
Actual Study Completion Date | December 23, 2016 | |||||||||
Actual Primary Completion Date | December 23, 2016 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender |
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Ages | 3 Years to 18 Years (Child, Adult) | |||||||||
Accepts Healthy Volunteers | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Canada, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT01368497 | |||||||||
Other Study ID Numbers ICMJE | 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 ) |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
Verification Date | February 2018 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |