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Trial record 156 of 324 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02952924
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study is sponsor-open, investigator-blinded, participant-blinded, randomized, placebo-controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study that will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and chronic HBV infected participants. The effect of food on the PK of RO7049389 and the effect of multiple dosing of RO7049389 on the PK of a single oral microdose of midazolam will be evaluated. The study will be conducted in two parts: Part 1 (1a [SAD cohort], 1b [Food-effect SAD cohort], 1c [MAD Cohort]) in healthy volunteers and Part 2 (Proof of mechanism [POM]) in chronic HBV infected participants.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Midazolam Other: Placebo Drug: RO7049389 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : December 14, 2016
Estimated Primary Completion Date : January 25, 2019
Estimated Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Part 1c: MAD in Healthy Volunteers (Placebo)
Participants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 13 (either once a day [QD] or twice a day [BID]) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 micrograms [mcg]) on Day -1 and Day 14.
Drug: Midazolam
Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo
Other: Placebo
Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
Experimental: Part 1c: MAD in Healthy Volunteers (RO7049389)
Participants will receive RO7049389 film coated tablet from Days 1 to 13 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 14. Participants will also receive a single dose of midazolam solution (100 mcg) on Day -1 and Day 14.
Drug: Midazolam
Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo
Drug: RO7049389
RO7049389 will be administered as per schedule described in individual arm.
Placebo Comparator: Part 2: POM in Chronic HBV Participants (Placebo)
Participants will receive placebo matching to RO7049389 film coated tablet from Days 1 to 27 (either QD or BID) and a single dose of placebo matching to RO7049389 film coated tablet in the morning of Day 28.
Other: Placebo
Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
Experimental: Part 2: POM in Chronic HBV Participants (RO7049389)
Participants will receive RO7049389 film coated tablet from Days 1 to 27 (either QD or BID; dose and regimen will be decided based on the available PK and safety data) and a single dose of RO7049389 film coated tablet in the morning of Day 28.
Drug: RO7049389
RO7049389 will be administered as per schedule described in individual arm.
Placebo Comparator: Parts 1a and 1b: SAD in Healthy Volunteers (Placebo)
In Part 1a, participants will receive a single oral dose of placebo matching to RO7049389 film coated tablet on Day 1. In Part 1b, minimum 8 participants from Part 1a will be selected and 2 of whom will receive another single dose of placebo matching to RO7049389 on Day 16 after eating the standard United States - Food and Drug Administration (US FDA)-recommended high-fat and high-calorie breakfast.
Other: Placebo
Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
Experimental: Parts 1a and 1b: SAD in Healthy Volunteers (RO7049389)
In Part 1a, participants will receive a single oral dose of RO7049389 film coated tablet on Day 1 in dose-escalation cohorts with a starting dose of 150 milligrams (mg). The doses for subsequent cohorts will be defined by an adaptive approach based on the safety and PK data in previously-dosed healthy volunteers. In Part 1b, minimum 8 participants from Part 1a will be selected and 6 of whom will receive another single dose of RO7049389 on Day 16 after eating the standard US FDA-recommended high-fat and high-calorie breakfast.
Drug: RO7049389
RO7049389 will be administered as per schedule described in individual arm.



Primary Outcome Measures :
  1. Part 1: Percentage of Participants With Adverse Events [ Time Frame: From randomization up to Day 44 ]
  2. Part 2: Percentage of Participants With Adverse Events [ Time Frame: From randomization up to Day 56 ]
  3. Part 2: HBV Deoxyribonucleic Acid (DNA) Level at Baseline [ Time Frame: Baseline ]
  4. Part 2: HBV DNA Level at Day 8 [ Time Frame: Day 8 ]
  5. Part 2: HBV DNA Level at Day 15 [ Time Frame: Day 15 ]
  6. Part 2: HBV DNA Level at Day 22 [ Time Frame: Day 22 ]
  7. Part 2: HBV DNA Level at Day 28 [ Time Frame: Day 28 ]
  8. Part 2: HBV DNA Level at Day 35 [ Time Frame: Day 35 ]
  9. Part 2: HBV DNA Level at Day 56 [ Time Frame: Day 56 ]
  10. Part 1c- MAD Cohort: Area Under the Plasma Concentration Versus Time Curve for a Dosing Interval (AUC0-tau) of RO7049389 [ Time Frame: Pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 5, and 7; pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post Day 14 morning dose ]
  11. Part 1c- MAD Cohort: Plasma Trough Concentration (Ctrough) of RO7049389 [ Time Frame: Pre-dose (0 hr before morning dose) on Days 2, 3, 4, 5, 7 ]
  12. Part 1c- MAD Cohort: Apparent Terminal t1/2 of RO7049389 [ Time Frame: Pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 5, and 7; pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post Day 14 morning dose ]
  13. Part 1c- MAD Cohort: Accumulation Index of RO7049389 [ Time Frame: Pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 5, and 7; pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post Day 14 morning dose ]
  14. Part 1c- MAD Cohort: Ae of RO7049389 [ Time Frame: Pre-dose (0 hr), 0-4, 4-8, 8-12, 12-24 hours post morning dose on Days 1 and 14 ]
  15. Part 1c- MAD Cohort: CLR of RO7049389 [ Time Frame: Pre-dose (0 hr), 0-4, 4-8, 8-12, 12-24 hours post morning dose on Days 1 and 14 ]
  16. Part 2: Change From Baseline in HBV DNA Level at Day 8 [ Time Frame: Baseline, Day 8 ]
  17. Part 2: Change From Baseline in HBV DNA Level at Day 15 [ Time Frame: Baseline, Day 15 ]
  18. Part 2: Change From Baseline in HBV DNA Level at Day 22 [ Time Frame: Baseline, Day 22 ]
  19. Part 2: Change From Baseline in HBV DNA Level at Day 28 [ Time Frame: Baseline, Day 28 ]
  20. Part 2: Change From Baseline in HBV DNA Level at Day 35 [ Time Frame: Baseline, Day 35 ]
  21. Part 2: Change From Baseline in HBV DNA Level at Day 56 [ Time Frame: Baseline, Day 56 ]
  22. Part 1a- SAD Cohort: Maximum Observed Plasma Concentration (Cmax) of RO7049389 [ Time Frame: Pre-dose (0 hour [hr]) on Day 1; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 1 dose ]
  23. Part 1a- SAD Cohort: Time to Reach Cmax (Tmax) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 1 dose ]
  24. Part 1a- SAD Cohort: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUC0-last) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 1 dose ]
  25. Part 1a- SAD Cohort: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 1 dose ]
  26. Part 1a- SAD Cohort: Apparent Terminal Half-life (t1/2) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 1 dose ]
  27. Part 1a- SAD Cohort: Apparent Oral Clearance (CL/F) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 1 dose ]
  28. Part 1a-SAD Cohort- Cumulative Amount Excreted Unchanged in Urine (Ae) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0-4, 4-8, 8-12, 12-24, 24-48 hours post Day 1 dose ]
  29. Part 1a- SAD Cohort: Renal Clearance (CLR) of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 1; 0-4, 4-8, 8-12, 12-24, 24-48 hours post Day 1 dose ]
  30. Part 1c- MAD Cohort: Cmax of RO7049389 [ Time Frame: Pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 5, and 7; pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post Day 14 morning dose ]
  31. Part 1c- MAD Cohort: Tmax of RO7049389 [ Time Frame: Pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 5, and 7; pre-dose (0 hr) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post Day 14 morning dose ]

Secondary Outcome Measures :
  1. Part 1b- Food-Effect SAD Cohort: Cmax of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 16; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 16 dose ]
  2. Part 1b- Food-Effect SAD Cohort: Tmax of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 16; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 16 dose ]
  3. Part 1b- Food-Effect SAD Cohort: AUC0-last of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 16; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 16 dose ]
  4. Part 1b- Food-Effect SAD Cohort: AUC0-inf of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 16; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 16 dose ]
  5. Part 1b- Food-Effect SAD Cohort: Apparent Terminal t1/2 of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 16; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 16 dose ]
  6. Part 1b- Food-Effect SAD Cohort: Apparent CL/F of RO7049389 [ Time Frame: Pre-dose (0 hr) on Day 16; 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hrs post Day 16 dose ]
  7. Part 1c- MAD Cohort: Cmax of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  8. Part 1c- MAD Cohort: Tmax of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  9. Part 1c- MAD Cohort: AUC0-last of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  10. Part 1c- MAD Cohort: AUC0-inf of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  11. Part 1c- MAD Cohort: Area Under the Plasma Concentration Versus Time Curve up to 6 h Post-dose (AUC0-6h) of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  12. Part 1c- MAD Cohort: Apparent Terminal t1/2 of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  13. Part 1c- MAD Cohort: CL/F of Midazolam [ Time Frame: Pre-dose (0 hr), 0.25, 0.5,1, 2, 4, 6, 8, 10, and 12 hrs post-midazolam dose on Day -1; pre-RO7049389 dose (0 hr) on Day 1; pre-dose (0 hr), 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hrs post-midazolam dose on Day 14 ]
  14. Part 2: Cmax of RO7049389 [ Time Frame: Pre-dose (0 hr) and 1, 2, 3, 4, 6, and 8 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 8, 15, 22; pre-dose (0 hr) and 1, 2, 3, 4, 6, 8, and 24 hrs post Day 28 morning dose ]
  15. Part 2: Tmax of RO7049389 [ Time Frame: Pre-dose (0 hr) and 1, 2, 3, 4, 6, and 8 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 8, 15, 22; pre-dose (0 hr) and 1, 2, 3, 4, 6, 8, and 24 hrs post Day 28 morning dose ]
  16. Part 2: AUC0-tau of RO7049389 [ Time Frame: Pre-dose (0 hr) and 1, 2, 3, 4, 6, and 8 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 8, 15, 22; pre-dose (0 hr) and 1, 2, 3, 4, 6, 8, and 24 hrs post Day 28 morning dose ]
  17. Part 2: Ctrough of RO7049389 [ Time Frame: Pre-dose (0 hr) and 1, 2, 3, 4, 6, and 8 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 8, 15, 22; pre-dose (0 hr) and 1, 2, 3, 4, 6, 8, and 24 hrs post Day 28 morning dose ]
  18. Part 2: Apparent t1/2 of RO7049389 [ Time Frame: Pre-dose (0 hr) and 1, 2, 3, 4, 6, and 8 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 8, 15, 22; pre-dose (0 hr) and 1, 2, 3, 4, 6, 8, and 24 hrs post Day 28 morning dose ]
  19. Part 2: Accumulation Index of RO7049389 [ Time Frame: Pre-dose (0 hr) and 1, 2, 3, 4, 6, and 8 hrs post Day 1 morning dose; pre-morning dose (0 hr) on Days 2, 3, 4, 8, 15, 22; pre-dose (0 hr) and 1, 2, 3, 4, 6, 8, and 24 hrs post Day 28 morning dose ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part 1- Healthy Volunteers only:

  • Absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead Electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
  • A Body Mass Index (BMI) between 18 to 30 kilograms per square meter (kg/m^2) inclusive
  • Female participants must be either surgically sterile or post-menopausal for at least one year
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Part 2- Chronic HBV-infected participants only:

  • A BMI between 18 to 30 kg/m^2 inclusive
  • Chronic Hepatitis B infection, defined as positive test for Hepatitis B surface antigen (HBsAg) for more than 6 months prior to randomization
  • HBV DNA at screening greater than or equal to (>/=) 2 × 10^4 international units per milliliter (IU/mL) for Hepatitis B e antigen (HBeAg) positive participants, or >/=2 × 10^3 IU/mL for HBeAg-negative participants
  • Liver biopsy, fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection with absence of extensive bridging fibrosis and absence of cirrhosis
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
  • For women of childbearing potential: agreement to remain abstinent or use non-hormonal contraceptive methods that result in a failure rate of less than (<)1 percent (%) per year during the treatment period and for at least 28 days after the last dose of study drug

Exclusion Criteria:

Part 1- Healthy Volunteers only:

  • History or symptoms of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
  • History of Gilbert's syndrome
  • Participants who have had significant acute infection, e.g., influenza, local infection, acute gastrointestinal symptoms or any other clinically significant illness within two weeks of dose administration
  • Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies
  • Any clinically significant concomitant diseases or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
  • Positive test at screening of any of the following: Hepatitis A (HAV IgM Ab), Hepatitis B (HBsAg), Hepatitis C (HCV RNA or HCV Ab) or human immunodeficiency virus (HIV Ab)
  • Acute narrow-angle glaucoma (for MAD-midazolam cohorts)

Part 2- Chronic HBV-infected participants only:

  • History or other evidence of bleeding from esophageal varices
  • Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, hepatic encephalopathy
  • History or other evidence of a medical condition associated with chronic liver disease other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, nonalcoholic steatohepatitis, etc.)
  • Documented history or other evidence of metabolic liver disease within one year of randomization
  • Positive test for hepatitis A (IgM anti-HAV), hepatitis C, hepatitis D, or human immunodeficiency virus
  • History of or suspicion of hepatocellular carcinoma or alphafetoprotein >/= Upper limit of normal (ULN) at screening
  • History of clinically significant gastrointestinal, cardiovascular, endocrine, renal, ocular, pulmonary, psychiatric or neurological disease
  • History of organ transplantation
  • Previous or concurrent HBV treatments in the past 6 months
  • Significant acute infection (e.g., influenza, local infection) or any other clinically significant illness within 2 weeks of randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952924


Contacts
Contact: Reference Study ID Number: YP39364 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
Australia, Queensland
Royal Brisbane and Women's Hospital Not yet recruiting
Herston, Queensland, Australia, 4029
Australia, Victoria
Royal Melbourne Hospital Not yet recruiting
Parkville, Victoria, Australia, 3050
Hong Kong
The University of Hong Kong; Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Prince of Wales Hospital Recruiting
Shatin, New Territories, Hong Kong
Korea, Republic of
Korea University Guro Hospital Withdrawn
Seoul, Korea, Republic of, 08308
SMG-SNU Boramae Medical Center Withdrawn
Seoul, Korea, Republic of, 156-707
Seoul National University College of Medicine, Liver Research Institute Withdrawn
Seoul, Korea, Republic of
University of Ulsan College of Medicine, Asan Medical Center, Digestive Disease Center Withdrawn
Seoul, Korea, Republic of
New Zealand
Middlemore Hospital Recruiting
Auckland, New Zealand
Auckland Clinical Studies Limited Recruiting
Grafton, New Zealand, 1010
Singapore
National University Health System Recruiting
Singapore, Singapore, 119228
Singapore General Hospital Not yet recruiting
Singapore, Singapore, 169608
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Kaohsiung City, Taiwan, 807
Chang Gung Memorial Hospital - Kaohsiung Branch Recruiting
Kaohsiung, Taiwan
Taichung Veterans Gen Hosp Recruiting
Taichung, Taiwan, 40705
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 112
Chang Gung Memorial Hospital - Linkou Branch Recruiting
Taipei, Taiwan
Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital Recruiting
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02952924     History of Changes
Other Study ID Numbers: YP39364
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action