Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults with Chronic Hepatitis B (HBRN Immune Tolerant A)
Study Design: Clinical Trial
Conditions: Hepatitis B, Hepatitis, Viral, Liver Diseases
Duration: 2012 – Present
# Recruitment Centers: 21
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 Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults with Chronic Hepatitis B (HBRN Immune Tolerant A) 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/NCT01369199
General Description
loss, HBeAg loss, HBeAg seroconversion, alanine aminotransferase (ALT) levels, and HBV DNA levels.
Objectives
The study’s primary objective is to evaluate the safety and efficacy of treatment with a combination of entecavir plus peginterferon alfa-2a in immune-tolerant adults with chronic hepatitis B.
Outcome Measure
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 96 weeks. 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, HBeAg loss, HBeAg seroconversion, alanine aminotransferase (ALT) levels, and HBV DNA levels
Criteria
Individuals of at least 18 years of age who met the following criteria were eligible for the study:
- Enrolled in the HBRN Adult Cohort Study or completed necessary components of the cohort baseline evaluation.
- Documented chronic hepatitis B infection, as evidenced by detection of HBsAg in serum for ≥24 weeks prior to baseline visit OR at least one positive HBsAg & negative anti-HBc IgM within 24 weeks prior to baseline visit OR at least one positive HBsAg & two positive HBV DNA over a period of ≥24 weeks prior to baseline visit.
- Presence of HBeAg in serum at last screening visit within 6 weeks of baseline visit.
- Serum HBV DNA level >10˄7 IU/mL on at least two occasions at least 12 weeks apart during the 52 weeks before baseline visit. One of the two HBV DNA levels must be within 6 weeks of baseline visit.
- ALT levels persistently ≤45 IU/L in males, ≤30 IU/L in females (approx. 1.5 times the upper limit of normal [ULN] range) as documented by at least three values: one taken 28-52 weeks before baseline visit, one taken 6 to 24 weeks before the baseline visit, & the final value within 6 weeks prior to baseline visit.
- No evidence of hepatocellular carcinoma (HCC)
Exclusion criteria are documented in the study protocol.
Outcome
This study is ongoing.