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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02391805




Registration number
NCT02391805
Ethics application status
Date submitted
6/03/2015
Date registered
18/03/2015
Date last updated
6/06/2018

Titles & IDs
Public title
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
Scientific title
A Multiple-Center, Randomized, Partially Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Effects of 12-Week Treatment With RO6864018 in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
NP28938
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Entecavir
Treatment: Drugs - Placebo
Treatment: Drugs - RO6864018
Treatment: Drugs - Tenofovir

Placebo Comparator: Placebo, Every Other Day (QOD) - Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Placebo Comparator: Placebo, Once a Week (QWk) - Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Experimental: RO6864018, 1200 milligrams (mg) QOD - RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Experimental: RO6864018, 1200 mg QWk - RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Experimental: RO6864018, 800 mg QOD - RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician

Experimental: RO6864018, 800 mg QWk - RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician


Treatment: Drugs: Entecavir
Entecavir will be administered as per local labeling.

Treatment: Drugs: Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.

Treatment: Drugs: 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.

Treatment: Drugs: Tenofovir
Tenofovir will be administered as per local labeling.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Percentage of Participants with Adverse Events
Timepoint [1] 0 0
Baseline up to approximately 36 weeks
Secondary outcome [1] 0 0
Pharmacodynamics: Peripheral Blood Levels of Interferon (IFN)-Alpha in QOD Dosing Cohorts
Timepoint [1] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [2] 0 0
Pharmacodynamics: Peripheral Blood Levels of IFN-Alpha in QWk Dosing Cohorts
Timepoint [2] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [3] 0 0
Pharmacodynamics: Peripheral Blood Levels of IFN-Gamma-Induced Protein (IP)-10 in QOD Dosing Cohorts
Timepoint [3] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [4] 0 0
Pharmacodynamics: Peripheral Blood Levels of IP-10 in QWk Dosing Cohorts
Timepoint [4] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [5] 0 0
Efficacy: Quantitative HBV Deoxyribonucleic Acid (DNA) Level in QOD Dosing Cohorts
Timepoint [5] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up; and at any point that breakthrough occurs (up to 36 weeks)
Secondary outcome [6] 0 0
Efficacy: Quantitative HBV DNA Level in QWk Dosing Cohorts
Timepoint [6] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up; and at any point that breakthrough occurs (up to 36 weeks)
Secondary outcome [7] 0 0
Efficacy: Quantitative Hepatitis B Surface Antigen (HBsAg) Level in QOD Dosing Cohorts
Timepoint [7] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [8] 0 0
Efficacy: Quantitative HBsAg Level in QWk Dosing Cohorts
Timepoint [8] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [9] 0 0
Efficacy: Percentage of Participants with Loss of HBsAg in QOD Dosing Cohorts
Timepoint [9] 0 0
Baseline; on Day 7 of Week 12; then at Week 36 during follow-up
Secondary outcome [10] 0 0
Efficacy: Percentage of Participants with Loss of HBsAg in QWk Dosing Cohorts
Timepoint [10] 0 0
Baseline; on Day 7 of Week 12; then at Week 36 during follow-up
Secondary outcome [11] 0 0
Efficacy: Percentage of Participants with Loss of Hepatitis B Envelope Antigen (HBeAg) in QOD Dosing Cohorts
Timepoint [11] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [12] 0 0
Efficacy: Percentage of Participants with Loss of HBeAg in QWk Dosing Cohorts
Timepoint [12] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [13] 0 0
Efficacy: Percentage of Participants with HBsAg Seroconversion in QOD Dosing Cohorts - HBsAg Seroconversion = antibody to HBsAg (Anti-HBs) Positive Status and Loss of HBsAg
Timepoint [13] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Week 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [14] 0 0
Efficacy: Percentage of Participants with HBsAg Seroconversion in QWk Dosing Cohorts - HBsAg Seroconversion = anti-HBs Positive Status and Loss of HBsAg
Timepoint [14] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [15] 0 0
Efficacy: Percentage of Participants with HBeAg Seroconversion in QOD Dosing Cohorts - HBeAg Seroconversion = antibody to HBeAg (anti-HBe) Positive Status and Loss of HBeAg
Timepoint [15] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Week 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [16] 0 0
Efficacy: Percentage of Participants with HBeAg Seroconversion in QWk Dosing Cohorts - HBeAg Seroconversion = anti-HBe Positive Status and Loss of HBeAg
Timepoint [16] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 5; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [17] 0 0
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of RO6864018 Metabolite in QOD Dosing Cohorts
Timepoint [17] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
Secondary outcome [18] 0 0
Pharmacokinetics: Cmax of RO6864018 Metabolite in QWk Dosing Cohorts
Timepoint [18] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Secondary outcome [19] 0 0
Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of RO6864018 Metabolite in QOD Dosing Cohorts
Timepoint [19] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
Secondary outcome [20] 0 0
Pharmacokinetics: Tmax of RO6864018 Metabolite in QWk Dosing Cohorts
Timepoint [20] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Secondary outcome [21] 0 0
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of RO6864018 Metabolite in QOD Dosing Cohorts
Timepoint [21] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
Secondary outcome [22] 0 0
Pharmacokinetics: AUCinf of RO6864018 Metabolite in QWk Dosing Cohorts
Timepoint [22] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Secondary outcome [23] 0 0
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve up to the Last Measurable Concentration (AUClast) of RO6864018 Metabolite in QOD Dosing Cohorts
Timepoint [23] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
Secondary outcome [24] 0 0
Pharmacokinetics: AUClast of RO6864018 Metabolite in QWk Dosing Cohorts
Timepoint [24] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Secondary outcome [25] 0 0
Pharmacokinetics: Half-life (t1/2) of RO6864018 Metabolite in QOD Dosing Cohorts
Timepoint [25] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Days 1, 7 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 3, 5, 7, 12 and Day 6 of Week 12
Secondary outcome [26] 0 0
Pharmacokinetics: T1/2 of RO6864018 Metabolite in QWk Dosing Cohorts
Timepoint [26] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Secondary outcome [27] 0 0
Pharmacodynamics: Peripheral Blood Levels of Neopterin in QOD Dosing Cohorts
Timepoint [27] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [28] 0 0
Pharmacodynamics: Peripheral Blood Levels of Neopterin in QWk Dosing Cohorts
Timepoint [28] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [29] 0 0
Pharmacodynamics: Peripheral Blood Levels of Tumor Necrosis Factor (TNF)-Alpha in QOD Dosing Cohorts
Timepoint [29] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [30] 0 0
Pharmacodynamics: Peripheral Blood Levels of TNF-alpha in QWk Dosing Cohorts
Timepoint [30] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [31] 0 0
Pharmacodynamics: Peripheral Blood Levels of Interleukin (IL)-6 in QOD Dosing Cohorts
Timepoint [31] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [32] 0 0
Pharmacodynamics: Peripheral Blood Levels of IL-6 in QWk Dosing Cohorts
Timepoint [32] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [33] 0 0
Pharmacodynamics: Peripheral Blood Levels of IL-10 in QOD Dosing Cohorts
Timepoint [33] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [34] 0 0
Pharmacodynamics: Peripheral Blood Levels of IL-10 in QWk Dosing Cohorts
Timepoint [34] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [35] 0 0
Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QOD Dosing Cohorts
Timepoint [35] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Days 1, 3, 7 of Week 1; on Day 1 of Weeks 3, 5, 7; and Day 6 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [36] 0 0
Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QWk Dosing Cohorts
Timepoint [36] 0 0
Baseline; pre-dose (0 hours) and post-dose (6, 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [37] 0 0
Efficacy: Percentage of Participants with Development of Anti-HBe in QOD Dosing Cohorts
Timepoint [37] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [38] 0 0
Efficacy: Percentage of Participants with Development of Anti-HBe in QWk Dosing Cohorts
Timepoint [38] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [39] 0 0
Efficacy: Percentage of Participants with Development of Anti-HBs in QOD Dosing Cohorts
Timepoint [39] 0 0
Baseline; pre-dose (0 hours) on Day 7 of Week 1 and Day 1 of Weeks 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [40] 0 0
Efficacy: Percentage of Participants with Development of Anti-HBs in QWk Dosing Cohorts
Timepoint [40] 0 0
Baseline; pre-dose (0 hours) on Day 1 of Weeks 2, 3, 5, 7; on Day 7 of Week 12; then at Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [41] 0 0
Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QWk Cohorts
Timepoint [41] 0 0
QWk: Baseline; pre-dose (0 hours) and post-dose (6 and 24 hours) on Day 1 of Weeks 1, 2, 3, 5, 7, 12, and Day 7 of Week 12; then Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [42] 0 0
Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QOD Cohorts
Timepoint [42] 0 0
Baseline; pre-dose; post-dose (6 and 24 hours) on Days 1, 3, and 7 for Week 1, Day 1 of Weeks 3, 5, 7, Day 6 of Week 12; then Weeks 16, 20, 24, 28, 32, 36 during follow-up
Secondary outcome [43] 0 0
Pharmacodynamics: Percentage of T Cells, B Cells, and NK Cells (TBNK)
Timepoint [43] 0 0
For QOD and QWk Cohorts: Baseline; pre-dose (0 hours) on Day 1 of Weeks 1, 2, 5; then Weeks 20, 28, 36 during follow-up
Secondary outcome [44] 0 0
Pharmacodynamics: Percentage of Myeloid Cells
Timepoint [44] 0 0
For QOD and QWk Cohorts: Baseline; pre-dose (0 hours) on Day 1 of Weeks 1, 2, 5; then Weeks 20, 28, 36 during follow-up
Secondary outcome [45] 0 0
Pharmacodynamics: Percentage of Plasmacytoid Dendritic Cells
Timepoint [45] 0 0
For QOD and QWk Cohorts: Baseline; pre-dose (0 hours) on Day 1 of Weeks 1, 2, 5; then Weeks 20, 28, 36 during follow-up
Secondary outcome [46] 0 0
Pharmacokinetics: Cmax of Entecavir in QWk Dosing Cohorts
Timepoint [46] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12
Secondary outcome [47] 0 0
Pharmacokinetics: AUCinf of Entecavir in QWk Dosing Cohorts
Timepoint [47] 0 0
Pre-dose (0 hours) and post-dose (0.25, 1, 2, 4, 6, 8, 12, 24 hours) on Day 1 of Week 1; pre-dose (0 hours) and post-dose (1, 2-4 hours) on Day 1 of Weeks 2, 3, 5, 7, 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Hong Kong
State/province [2] 0 0
N.t.
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Ampang
Country [5] 0 0
Malaysia
State/province [5] 0 0
Batu Caves
Country [6] 0 0
Malaysia
State/province [6] 0 0
Kuala Lumpur
Country [7] 0 0
New Zealand
State/province [7] 0 0
Grafton
Country [8] 0 0
New Zealand
State/province [8] 0 0
Hamilton
Country [9] 0 0
Singapore
State/province [9] 0 0
Singapore
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaohsiung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei City
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02391805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications