SUSTAINED RESPONSE TO NUCLEO(S)TIDE ANALOGUES FOR CHRONIC HEPATITIS B: SNAP STUDY

Phase 4

Conditions: hepatitis B
10047438

Registration Number: NL-OMON50717

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Age 18 * 65 years
Treatment with entecavir or tenofovir
Previously HBeAg positive patients: stable HBeAg seroconversion (confirmed
HBeAg seroconversion at least 6 months apart) with at least 12 months of
subsequent consolidation therapy with HBV DNA <80 IU/mL
HBeAg negative patients: at least 3 years of continuous viral suppression (HBV
DNA <80 IU/mL)
Fibroscan value <7.0 at baseline

Exclusion Criteria

* History of liver biopsy with advanced fibrosis or cirrhosis (F3 or F4)
* History of hepatic decompensation
* (history of) hepatocellular carcinoma
* Other active malignancy
* (planned) treatment with immunosuppressive agents
* (planned) pregnancy
* Coinfection with HIV, HCV, HDV
* Concomitant liver condition that may influence liver chemistry (such as
Gilbert*s syndrome). Defined as baseline ALT > 2x upper limit of normal, and/or
bilirubin > 1x upper limit of normal.
* Other indication for continued nucleo(s)tide analogue therapy
* Expected noncompliance to follow-up
* Treatment with medication that increases INR (such as vitamin K antagonists)
* Unwillingness to refrain from sexual activity without condom with partners
who are not vaccinated against hepatitis B virus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>sustained response (HBV DNA <2,000) at week 48 after discontinuation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Long-term sustained response, defined as HBV DNA < 2,000 IU/mL at week 96<br /><br>after therapy discontinuation.<br /><br>2. Need for retreatment (according to study protocol or treating physician)<br /><br>3. HBsAg clearance at week 48 and 96<br /><br>4. Occurrence of signs of liver failure (bilirubin > 1.5 x the upper limit of<br /><br>normal and/or INR > 1.5)<br /><br>5. Relationship between sustained response at week 48 and 96 and serum levels<br /><br>of HBsAg at the time of treatment cessation<br /><br>6. ALT levels at week 48 and 96<br /><br>7. Fibroscan value at week 96 </p><br>