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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02391805
First received: March 6, 2015
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Hepatitis B, Chronic Drug: Entecavir Drug: Placebo Drug: RO6864018 Drug: Tenofovir Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 36 weeks ]

Secondary Outcome Measures:
  • Pharmacodynamics: Peripheral Blood Levels of Interferon (IFN)-Alpha in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IFN-Alpha in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IFN-Gamma-Induced Protein (IP)-10 in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IP-10 in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Quantitative HBV Deoxyribonucleic Acid (DNA) Level in QOD Dosing Cohorts [ Time Frame: 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) ]
  • Efficacy: Quantitative HBV DNA Level in QWk Dosing Cohorts [ Time Frame: 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) ]
  • Efficacy: Quantitative Hepatitis B Surface Antigen (HBsAg) Level in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Quantitative HBsAg Level in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with Loss of HBsAg in QOD Dosing Cohorts [ Time Frame: Baseline; on Day 7 of Week 12; then at Week 36 during follow-up ]
  • Efficacy: Percentage of Participants with Loss of HBsAg in QWk Dosing Cohorts [ Time Frame: Baseline; on Day 7 of Week 12; then at Week 36 during follow-up ]
  • Efficacy: Percentage of Participants with Loss of Hepatitis B Envelope Antigen (HBeAg) in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with Loss of HBeAg in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with HBsAg Seroconversion in QOD Dosing Cohorts [ Time Frame: 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 ]
    HBsAg Seroconversion = antibody to HBsAg (Anti-HBs) Positive Status and Loss of HBsAg

  • Efficacy: Percentage of Participants with HBsAg Seroconversion in QWk Dosing Cohorts [ Time Frame: 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 ]
    HBsAg Seroconversion = anti-HBs Positive Status and Loss of HBsAg

  • Efficacy: Percentage of Participants with HBeAg Seroconversion in QOD Dosing Cohorts [ Time Frame: 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 ]
    HBeAg Seroconversion = antibody to HBeAg (anti-HBe) Positive Status and Loss of HBeAg

  • Efficacy: Percentage of Participants with HBeAg Seroconversion in QWk Dosing Cohorts [ Time Frame: 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 ]
    HBeAg Seroconversion = anti-HBe Positive Status and Loss of HBeAg

  • Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of RO6864018 Metabolite in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: Cmax of RO6864018 Metabolite in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of RO6864018 Metabolite in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: Tmax of RO6864018 Metabolite in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of RO6864018 Metabolite in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: AUCinf of RO6864018 Metabolite in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: Area Under the Plasma Concentration-Time Curve up to the Last Measurable Concentration (AUClast) of RO6864018 Metabolite in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: AUClast of RO6864018 Metabolite in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: Half-life (t1/2) of RO6864018 Metabolite in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: T1/2 of RO6864018 Metabolite in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of Neopterin in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of Neopterin in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of Tumor Necrosis Factor (TNF)-Alpha in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of TNF-alpha in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of Interleukin (IL)-6 in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IL-6 in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IL-10 in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IL-10 in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Peripheral Blood Levels of IL-12p40 in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with Development of Anti-HBe in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with Development of Anti-HBe in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with Development of Anti-HBs in QOD Dosing Cohorts [ Time Frame: 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 ]
  • Efficacy: Percentage of Participants with Development of Anti-HBs in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QWk Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Transcriptional Responses as Measured by messenger ribonucleic acid (mRNA) Levels for QOD Cohorts [ Time Frame: 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 ]
  • Pharmacodynamics: Percentage of T Cells, B Cells, and NK Cells (TBNK) [ Time Frame: 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 ]
  • Pharmacodynamics: Percentage of Myeloid Cells [ Time Frame: 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 ]
  • Pharmacodynamics: Percentage of Plasmacytoid Dendritic Cells [ Time Frame: 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 ]
  • Pharmacokinetics: Cmax of Entecavir in QWk Dosing Cohorts [ Time Frame: 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 ]
  • Pharmacokinetics: AUCinf of Entecavir in QWk Dosing Cohorts [ Time Frame: 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 ]

Enrollment: 30
Actual Study Start Date: May 17, 2015
Estimated Study Completion Date: November 28, 2017
Estimated Primary Completion Date: November 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo, Every Other Day (QOD)
Placebo orally (PO) QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Drug: Entecavir
Entecavir will be administered as per local labeling.
Drug: Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
Drug: Tenofovir
Tenofovir will be administered as per local labeling.
Placebo Comparator: Placebo, Once a Week (QWk)
Placebo PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Drug: Entecavir
Entecavir will be administered as per local labeling.
Drug: Placebo
Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
Drug: Tenofovir
Tenofovir will be administered as per local labeling.
Experimental: RO6864018, 1200 milligrams (mg) QOD
RO6864018 1200 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Drug: Entecavir
Entecavir will be administered as per local labeling.
Drug: 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.
Drug: Tenofovir
Tenofovir will be administered as per local labeling.
Experimental: RO6864018, 1200 mg QWk
RO6864018 1200 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Drug: Entecavir
Entecavir will be administered as per local labeling.
Drug: 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.
Drug: Tenofovir
Tenofovir will be administered as per local labeling.
Experimental: RO6864018, 800 mg QOD
RO6864018 800 mg PO QOD for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Drug: Entecavir
Entecavir will be administered as per local labeling.
Drug: 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.
Drug: Tenofovir
Tenofovir will be administered as per local labeling.
Experimental: RO6864018, 800 mg QWk
RO6864018 800 mg PO QWk for 12 weeks + noninvestigational entecavir or tenofovir as prescribed by participant's physician
Drug: Entecavir
Entecavir will be administered as per local labeling.
Drug: 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.
Drug: Tenofovir
Tenofovir will be administered as per local labeling.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02391805

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Malaysia
Hospital Ampang
Ampang, Malaysia, 68000
Hospital Selayang; Medicine
Batu Caves, Malaysia, 68100
University Malaya Medical Center
Kuala Lumpur, Malaysia, 59100
New Zealand
Auckland Clinical Studies Limited
Grafton, New Zealand, 1010
Waikato Hospital
Hamilton, New Zealand, 3248
Singapore
Changi General Hospital
Singapore, Singapore, 529889
Taiwan
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung, Taiwan, 807
Taipei Veterans General Hospital
Taipei, Taiwan, 00112
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02391805     History of Changes
Other Study ID Numbers: NP28938
Study First Received: March 6, 2015
Last Updated: June 12, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 26, 2017