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Trial record 57 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B

This study is currently recruiting participants.
Verified September 2017 by Hoffmann-La Roche
Sponsor:
ClinicalTrials.gov Identifier:
NCT03038113
First Posted: January 31, 2017
Last Update Posted: September 22, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of two sub-parts which will be used to further refine the dose and dosing regimen.

Condition Intervention Phase
Chronic Hepatitis B Drug: RO7062931 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Sponsor-Open, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of RO7062931 With Single Ascending Doses in Healthy Volunteers and Multiple Doses and Modified Regimens 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:
  • Percentage of Participants with Adverse Events (AEs) and AEs of Special Interest [ Time Frame: Up to Day 57 ]
  • Percentage of Participants with Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results [ Time Frame: Up to Day 57 ]
  • Percentage of Participants with Electrocardiogram (ECG) Abnormalities [ Time Frame: Up to Day 57 ]
  • Percentage of Participants with Abnormalities in Vital Signs, Including Blood Pressure, Heart Rate, and Temperature [ Time Frame: Up to Day 57 ]

Secondary Outcome Measures:
  • Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Maximum Plasma Concentration (Cmax) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Maximum Plasma Concentration (Cmax) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Maximum Plasma Concentration (Cmax) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero until the Last Quantifiable Time-Point (AUC0-last) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero until the Last Quantifiable Time-Point (AUC0-last) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero until the Last Quantifiable Time-Point (AUC0-last) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Terminal Elimination Rate Constant (k) After Single Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Terminal Elimination Rate Constant (k) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Terminal Elimination Rate Constant (k) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Terminal Elimination Rate Constant (k) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Total Clearance (CL) After Single Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Total Clearance (CL) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Total Clearance (CL) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Total Clearance (CL) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Volume of Distribution (Vss) After Single Ascending Doses - Part 1 [ Time Frame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 18 hours post dose Day 1; 24, 30, and 36 hours post dose Day 2; 48 hours post dose Day 3; 72 hours post dose Day 4; 96 hours post dose Day 5; 120 hours post dose Day 6; 168 hours post dose Day 8 ]
  • Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2a [ Time Frame: Predose, 0.5, 1,2, 4, 6, 8 hours post dose Day 1; 24 hours post dose Day 2; Day 8; Predose, 2 hrs post dose Day 15; Day 22; Predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Discontinuation; Days 36, 43, 50, 57 ]
  • Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2b, Every 2 Weeks (Q2W) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; Day 8; predose, 2 hours post dose Day 15; Day 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2b, Every Week (QW) [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, hours post dose Day 1; 24 hours post dose Days 2; predose, 2 hours post dose Days 8, 15 22; predose, 0.5, 1, 2, 4, 6, 8 hours post dose Day 29; 24 hours post dose Day 30; Days 36, 43, 50, 57 ]
  • Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1 [ Time Frame: 0-4, 4-8, 8-12 and 12-24 hrs post-dose on Days 1 and 2 ]
  • Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2 [ Time Frame: 0-4, 4-8, 8-12 and 12-24 hrs post-dose on Days 1 and 2 ]
  • Change from baseline of Quantitative HBsAg (log10) After Multiple Ascending Doses - Part 2a [ Time Frame: Screening, D1, D2, D8, D15, D22, D29 predose, D30, D36, D43, D50, D57 ]
  • Change from baseline of Quantitative HBsAg (log10) After Multiple Ascending Doses - Part 2b, Q2W [ Time Frame: Part 2b Q2W: Screening, D1, D2, D8, D15 predose, D22, D29 predose, D30, D36, D43, D50, D57 ]
  • Change from baseline of Quantitative HBsAg (log10) After Multiple Ascending Doses - Part 2b QW [ Time Frame: Part 2b QW: Screening, D1, D2, D8 predose, D15 predose, D22 predose, D29 predose, D30, D36, D43, D50, D57 ]
  • Maximum Change from Baseline in Quantitative HBsAg Across All Time-Points After Multiple Ascending Doses - Part 2a [ Time Frame: Screening, D1, D2, D8, D15, D22, D29 predose, D30, D36, D43, D50, D57 ]
  • Maximum Change from Baseline in Quantitative HBsAg Across All Time-Points After Multiple Ascending Doses - Part 2b, Q2W [ Time Frame: Part 2b Q2W: Screening, D1, D2, D8, D15 predose, D22, D29 predose, D30, D36, D43, D50, D57 ]
  • Maximum Change from Baseline in Quantitative HBsAg Across All Time-Points After Multiple Ascending Doses - Part 2b QW [ Time Frame: Part 2b QW: Screening, D1, D2, D8 predose, D15 predose, D22 predose, D29 predose, D30, D36, D43, D50, D57 ]
  • Rate of Decrease for HBsAg at Each Time-Point After Multiple Ascending Doses - Part 2a [ Time Frame: Screening, D1, D2, D8, D15, D22, D29 predose, D30, D36, D43, D50, D57 ]
  • Rate of Decrease for HBsAg at Each Time-Point After Multiple Ascending Doses - Part 2b, Q2W [ Time Frame: Part 2b Q2W: Screening, D1, D2, D8, D15 predose, D22, D29 predose, D30, D36, D43, D50, D57 ]
  • Rate of Decrease for HBsAg at Each Time-Point After Multiple Ascending Doses - Part 2b QW [ Time Frame: Part 2b QW: Screening, D1, D2, D8 predose, D15 predose, D22 predose, D29 predose, D30, D36, D43, D50, D57 ]

Estimated Enrollment: 160
Actual Study Start Date: February 6, 2017
Estimated Study Completion Date: November 13, 2018
Estimated Primary Completion Date: November 13, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Single-Ascending Dose (SAD)
Healthy volunteers will be enrolled in up to 8 cohorts with doses starting from 0.1 mg/kg and escalating sequentially after review of safety and pharmacokinetic (PK) data.
Drug: RO7062931
Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b a dose selected from Part 2a based on HBsAg decline or the max dose well tolerated, will be administered to participants randomized in 2 parallel cohorts where they will receive either the full dose every two weeks (3 doses), or half the dose weekly (5 doses).
Drug: Placebo
Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.
Experimental: Part 2: Multiple Ascending Dose
Participants with Chronic Hepatitis B will enrolled in Part 2. In Part 2a, participants will receive two monthly injections of either 3 doses equivalent to a multiple of the saturation dose or placebo in a 1:1:1:1 ratio. In Part 2b a dose selected from Part 2a based on HBsAg decline or the max dose well tolerated, will be administered to participants randomized in 2 parallel cohorts where they will receive either the full dose every two weeks (3 doses), or half the dose weekly (5 doses). Each of the two cohorts in Part 2b will include participants receiving active drug or placebo in a 3:1 ratio.
Drug: RO7062931
Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b a dose selected from Part 2a based on HBsAg decline or the max dose well tolerated, will be administered to participants randomized in 2 parallel cohorts where they will receive either the full dose every two weeks (3 doses), or half the dose weekly (5 doses).
Drug: Placebo
Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.

  Eligibility

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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

FOR HEALTHY VOLUNTEERS ONLY - PART 1 -

  • A Body Mass Index (BMI) between 18 to 30 kg/m2 inclusive and a body weight of at least 50 kg.
  • Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.
  • Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.

FOR CHB PARTICIPANTS ONLY - PART 2:

  • A BMI between 18 to 32 kg/m2 inclusive.
  • Chronic hepatitis B (HBV) infection.
  • Positive test for HBsAg for more than 6 months prior to randomization and HBsAg titer ≥ 10^3 IU/mL at screening.
  • On entecavir, tenofovir, adefovir or telbivudine treatment for at least 6 months prior to randomization and will remain on stable treatment during the study.
  • HBV deoxyribonucleic acid (DNA) ≤ 90 IU/mL for at least the preceding 6 months.
  • Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 56 days prior to first study treatment within normal ranges.
  • Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
  • Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.

Exclusion Criteria:

FOR HEALTHY VOLUNTEERS ONLY - PART 1:

  • History of drug or alcohol abuse or dependence in previous 6 months.
  • Positive urine drug and alcohol screen at Day -1.
  • Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
  • Confirmed blood pressure or resting pulse rate outside of accepted ranges.
  • Participation in an investigational drug or device study within 90 days prior to screening.
  • Donation of blood over 500 mL within three months prior to screening.
  • Any major illness within the one month, or any febrile illness within two weeks preceding the screening visit.
  • Alcohol consumption of more than 2 standard drinks per day on average.

FOR CHB PARTICIPANTS ONLY - PART 2:

  • History or other evidence of bleeding from esophageal varices.
  • Decompensated liver disease.
  • History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥ 13 ng/mL at Screening
  • History or other evidence of a medical condition associated with chronic liver disease other than HBV infection.
  • Documented history or other evidence of metabolic liver disease within one year of randomization or documented history of infection with hepatitis D virus.
  • Positive test for hepatitis A (IgM anti-HAV), hepatitis C, or HIV.
  • Organ transplantation.
  • Significant acute infection or any other clinically significant illness within 2 weeks of randomization.
  • Abnormal renal function.
  • Participation in an investigational drug or device study within 30 days prior to randomization.
  • Donation or loss of blood over 500 mL within 3 months prior to starting study medication.
  • Administration of any blood product within 3 months of randomization.
  • History or evidence of alcohol abuse (consumption of more than 2 standard drinks per day on average).
  Contacts and Locations
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): NCT03038113


Contacts
Contact: eference Study ID Number: BP39405 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand, 1142
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03038113     History of Changes
Other Study ID Numbers: BP39405
First Submitted: January 30, 2017
First Posted: January 31, 2017
Last Update Posted: September 22, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections