Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-07 @ 10:50 PM
Study NCT ID:
NCT02391805
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2015-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2015-03-06', 'studyFirstSubmitQcDate': '2015-03-12', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Percentage of Participants with Adverse Events', 'timeFrame': 'Baseline up to approximately 36 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics: Peripheral Blood Levels of Interferon (IFN)-Alpha in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IFN-Alpha in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IFN-Gamma-Induced Protein (IP)-10 in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IP-10 in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Quantitative HBV Deoxyribonucleic Acid (DNA) Level in QOD Dosing Cohorts', 'timeFrame': '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)'}, {'measure': 'Efficacy: Quantitative HBV DNA Level in QWk Dosing Cohorts', 'timeFrame': '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)'}, {'measure': 'Efficacy: Quantitative Hepatitis B Surface Antigen (HBsAg) Level in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Quantitative HBsAg Level in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with Loss of HBsAg in QOD Dosing Cohorts', 'timeFrame': 'Baseline; on Day 7 of Week 12; then at Week 36 during follow-up'}, {'measure': 'Efficacy: Percentage of Participants with Loss of HBsAg in QWk Dosing Cohorts', 'timeFrame': 'Baseline; on Day 7 of Week 12; then at Week 36 during follow-up'}, {'measure': 'Efficacy: Percentage of Participants with Loss of Hepatitis B Envelope Antigen (HBeAg) in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with Loss of HBeAg in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with HBsAg Seroconversion in QOD Dosing Cohorts', 'timeFrame': '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', 'description': 'HBsAg Seroconversion = antibody to HBsAg (Anti-HBs) Positive Status and Loss of HBsAg'}, {'measure': 'Efficacy: Percentage of Participants with HBsAg Seroconversion in QWk Dosing Cohorts', 'timeFrame': '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', 'description': 'HBsAg Seroconversion = anti-HBs Positive Status and Loss of HBsAg'}, {'measure': 'Efficacy: Percentage of Participants with HBeAg Seroconversion in QOD Dosing Cohorts', 'timeFrame': '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', 'description': 'HBeAg Seroconversion = antibody to HBeAg (anti-HBe) Positive Status and Loss of HBeAg'}, {'measure': 'Efficacy: Percentage of Participants with HBeAg Seroconversion in QWk Dosing Cohorts', 'timeFrame': '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', 'description': 'HBeAg Seroconversion = anti-HBe Positive Status and Loss of HBeAg'}, {'measure': 'Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of RO6864018 Metabolite in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Cmax of RO6864018 Metabolite in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of RO6864018 Metabolite in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Tmax of RO6864018 Metabolite in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of RO6864018 Metabolite in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: AUCinf of RO6864018 Metabolite in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Area Under the Plasma Concentration-Time Curve up to the Last Measurable Concentration (AUClast) of RO6864018 Metabolite in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: AUClast of RO6864018 Metabolite in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Half-life (t1/2) of RO6864018 Metabolite in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: T1/2 of RO6864018 Metabolite in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of Neopterin in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of Neopterin in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of Tumor Necrosis Factor (TNF)-Alpha in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of TNF-alpha in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of Interleukin (IL)-6 in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IL-6 in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IL-10 in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IL-10 in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with Development of Anti-HBe in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with Development of Anti-HBe in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with Development of Anti-HBs in QOD Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Efficacy: Percentage of Participants with Development of Anti-HBs in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QWk Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QOD Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Percentage of T Cells, B Cells, and NK Cells (TBNK)', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Percentage of Myeloid Cells', 'timeFrame': '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'}, {'measure': 'Pharmacodynamics: Percentage of Plasmacytoid Dendritic Cells', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: Cmax of Entecavir in QWk Dosing Cohorts', 'timeFrame': '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'}, {'measure': 'Pharmacokinetics: AUCinf of Entecavir in QWk Dosing Cohorts', 'timeFrame': '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'}]}, 'conditionsModule': {'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis B infection\n* Positive test for HBsAg for more than 6 months prior to randomization\n* HBsAg titer greater than or equal to (\\>/=) 250 international units per milliliter (IU/mL) at Screening\n* 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\n* HBV DNA less than (\\<) 90 IU/mL for at least the preceding 6 months\n* HBeAg positive at randomization and for at least 6 months prior to randomization\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Documented history of HBV genotype D\n* History or other evidence of bleeding from esophageal varices\n* History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease\n* Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)\n* Documented history of hepatitis D infection\n* History of or suspicion of hepatocellular carcinoma\n* History of immunologically mediated disease\n* History of organ transplantation\n* History of thyroid disease\n* Significant acute infection'}, 'identificationModule': {'nctId': 'NCT02391805', 'briefTitle': 'A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NP28938'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Every Other Day (QOD)', 'description': "Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician", 'interventionNames': ['Drug: Entecavir', 'Drug: Placebo', 'Drug: Tenofovir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Once a Week (QWk)', 'description': "Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician", 'interventionNames': ['Drug: Entecavir', 'Drug: Placebo', 'Drug: Tenofovir']}, {'type': 'EXPERIMENTAL', 'label': 'RO6864018, 1200 milligrams (mg) QOD', 'description': "RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician", 'interventionNames': ['Drug: Entecavir', 'Drug: RO6864018', 'Drug: Tenofovir']}, {'type': 'EXPERIMENTAL', 'label': 'RO6864018, 1200 mg QWk', 'description': "RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician", 'interventionNames': ['Drug: Entecavir', 'Drug: RO6864018', 'Drug: Tenofovir']}, {'type': 'EXPERIMENTAL', 'label': 'RO6864018, 800 mg QOD', 'description': "RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician", 'interventionNames': ['Drug: Entecavir', 'Drug: RO6864018', 'Drug: Tenofovir']}, {'type': 'EXPERIMENTAL', 'label': 'RO6864018, 800 mg QWk', 'description': "RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician", 'interventionNames': ['Drug: Entecavir', 'Drug: RO6864018', 'Drug: Tenofovir']}], 'interventions': [{'name': 'Entecavir', 'type': 'DRUG', 'description': 'Entecavir will be administered as per local labeling.', 'armGroupLabels': ['Placebo, Every Other Day (QOD)', 'Placebo, Once a Week (QWk)', 'RO6864018, 1200 mg QWk', 'RO6864018, 1200 milligrams (mg) QOD', 'RO6864018, 800 mg QOD', 'RO6864018, 800 mg QWk']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.', 'armGroupLabels': ['Placebo, Every Other Day (QOD)', 'Placebo, Once a Week (QWk)']}, {'name': 'RO6864018', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['RO6864018, 1200 mg QWk', 'RO6864018, 1200 milligrams (mg) QOD', 'RO6864018, 800 mg QOD', 'RO6864018, 800 mg QWk']}, {'name': 'Tenofovir', 'type': 'DRUG', 'description': 'Tenofovir will be administered as per local labeling.', 'armGroupLabels': ['Placebo, Every Other Day (QOD)', 'Placebo, Once a Week (QWk)', 'RO6864018, 1200 mg QWk', 'RO6864018, 1200 milligrams (mg) QOD', 'RO6864018, 800 mg QOD', 'RO6864018, 800 mg QWk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'N.T.', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital; Special Medical Clinic'}, {'zip': '68000', 'city': 'Ampang', 'country': 'Malaysia', 'facility': 'Hospital Ampang', 'geoPoint': {'lat': 3.15, 'lon': 101.76667}}, {'zip': '68100', 'city': 'Batu Caves', 'country': 'Malaysia', 'facility': 'Hospital Selayang; Medicine', 'geoPoint': {'lat': 3.238, 'lon': 101.682}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '1010', 'city': 'Grafton', 'country': 'New Zealand', 'facility': 'Auckland Clinical Studies Limited', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '3248', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}