Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children with Chronic Hepatitis B Virus Infection (HBRN Immune Tolerant P)
Study Design: Clinical Trial
Conditions: Hepatitis B, Hepatitis, Viral, Liver Diseases
Duration: 2011 – Present
# Recruitment Centers: 7
Treatment: Drug therapy: entecavir and peginterferon
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children with Chronic Hepatitis B Virus Infection (HBRN Immune Tolerant P) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT01368497
hepatitis B surface antigen (HBsAg) loss, HBeAg loss, HBeAg or HBsAg seroconversion, alanine aminotransferase (ALT) levels, HBV DNA levels, and absence of detectable antiviral drug-resistance HBV mutations.
The primary objective of the study is to determine whether treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon leads to an increased rate of sustained virologic response in children with immunotolerant HBV infection, when compared to no treatment, the current standard of care.
The primary outcome measures for evaluation of drug efficacy are HBeAg loss (lack of detectable HBeAg) and HBV DNA levels ≤1,000 IU/mL at 48 weeks following cessation of treatment. The number, type, and rate of adverse or serious events through end of treatment at 48 weeks and end of follow-up at 96 weeks will be assessed as the primary outcome measures for safety. Secondary outcome measures, evaluated at 48 and 96 weeks, include hepatitis B surface antigen (HBsAg) loss, hepatitis B e antigen (HBeAg) loss, HBeAg or HBsAg seroconversion, alanine aminotransferase (ALT) levels, HBV DNA levels, and absence of detectable antiviral drug-resistance HBV mutations.
Individuals between the ages of 3 and 18 years who met the following criteria were eligible for the study:
- Documented chronic HBV infection (as evidenced by detection of HBsAg in serum for ≥ 24 weeks prior to baseline; or positive HBsAg and negative anti-HBc IgM within 24 weeks of baseline visit)
- Presence of 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
- ALT ≤ 60 IU/l in males or ≤40 IU/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
- Compensated liver disease, with normal total bilirubin (except if Gilbert's syndrome), direct bilirubin ≤0.5 mg/dL, 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 are documented in the study protocol.
This study is ongoing, but not recruiting participants.