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A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection

NCT02391805

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis B, Chronic

Interventions: Entecavir, Placebo, RO6864018, Tenofovir

Countries: Hong Kong, Malaysia, New Zealand, Singapore, South Korea, Taiwan

This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Chronic hepatitis B infection
* Positive test for HBsAg for more than 6 months prior to randomization
* HBsAg titer greater than or equal to (\>/=) 250 international units per milliliter (IU/mL) at Screening
* Treatment with any nucleoside/nucleotide analogue for \>/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization
* HBV DNA less than (\<) 90 IU/mL for at least the preceding 6 months
* HBeAg positive at randomization and for at least 6 months prior to randomization

Exclusion Criteria:

* Pregnant or lactating women
* Documented history of HBV genotype D
* History or other evidence of bleeding from esophageal varices
* History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease
* Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
* Documented history of hepatitis D infection
* History of or suspicion of hepatocellular carcinoma
* History of immunologically mediated disease
* History of organ transplantation
* History of thyroid disease
* Significant acute infection
Locations (14)
  • Hong Kong, Hong Kong
  • N.T., Hong Kong
  • Ampang, Malaysia
  • Batu Caves, Malaysia
  • Kuala Lumpur, Malaysia
  • Grafton, New Zealand
  • Hamilton, New Zealand
  • Singapore, Singapore
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Kaohsiung City, Taiwan
  • Taipei, Taiwan
  • Taipei, Taiwan