Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chr… (NCT01369199) | Clinical Trial Compass
TerminatedPhase 3
Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B
United States28 participantsStarted 2012-05
Plain-language summary
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Enrolled in \& completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit.
* \>18 years of age at the baseline visit (day 0). Patients \>50 years of age at baseline will need to have a liver biopsy as standard of care with hepatic activity index (HAI) ≤3 \& Ishak fibrosis score ≤1 within 96 weeks prior to baseline visit.
* Documented chronic HBV infection as evidenced by detection of HBsAg in serum for ≥24 weeks prior to baseline visit OR at least one positive HBsAg \& negative anti-hepatitis B core (HBc) immunoglobulin (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 U/L in males, ≤30 U/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) based upon alpha-fetoprotein (AFP) ≤20 ng/mL at screening visit (up to 6 w…
What they're measuring
1
Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL
Timeframe: End of follow-up (up to 96 weeks)
2
Incidence of Adverse Events (AEs) Per Person-Year of Observation
Timeframe: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
3
Incidence of Serious Adverse Events (SAEs) Per Person-Year
Timeframe: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)
Trial details
NCT IDNCT01369199
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)