A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
NCT ID: NCT02391805
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2015-05-17
2017-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo, Every Other Day (QOD)
Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Entecavir
Entecavir will be administered as per local labeling.
Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
Placebo, Once a Week (QWk)
Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Entecavir
Entecavir will be administered as per local labeling.
Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
RO6864018, 1200 milligrams (mg) QOD
RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Entecavir
Entecavir will be administered as per local labeling.
RO6864018
Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
RO6864018, 1200 mg QWk
RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Entecavir
Entecavir will be administered as per local labeling.
RO6864018
Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
RO6864018, 800 mg QOD
RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Entecavir
Entecavir will be administered as per local labeling.
RO6864018
Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
RO6864018, 800 mg QWk
RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Entecavir
Entecavir will be administered as per local labeling.
RO6864018
Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
Interventions
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Entecavir
Entecavir will be administered as per local labeling.
Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
RO6864018
Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
Tenofovir
Tenofovir will be administered as per local labeling.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital; Special Medical Clinic
N.T., , Hong Kong
Hospital Ampang
Ampang, , Malaysia
Hospital Selayang; Medicine
Batu Caves, , Malaysia
University Malaya Medical Center
Kuala Lumpur, , Malaysia
Auckland Clinical Studies Limited
Grafton, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Changi General Hospital
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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NP28938
Identifier Type: -
Identifier Source: org_study_id
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