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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
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
Sex
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
17/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/10/2017
Sample size
Target
Accrual to date
Final
31
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02391805