Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
NCT ID: NCT01368497
Last Updated: 2022-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2012-09-30
2016-12-23
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Entecavir and peginterferon
Entecavir for 8 weeks followed by 40 weeks of both entecavir and peginterferon
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
3 Years
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Averell Sherker, MD
Role: STUDY_CHAIR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ed Doo, MD
Role: STUDY_CHAIR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Kathleen Schwarz, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of California San Francisco Medical Center
San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Saint Louis Children's Medical Center
St Louis, Missouri, United States
University of Texas Southwestern
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital of Sick Children
Toronto, Ontario, Canada
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A-DK-3002-001
Identifier Type: OTHER
Identifier Source: secondary_id
DK082864 HBRN IT Peds Trial
Identifier Type: -
Identifier Source: org_study_id
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