A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02391805
First received: March 6, 2015
Last updated: August 1, 2016
Last verified: August 2016
History of Changes
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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.
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B
Drug Information available for: Entecavir Tenofovir Tenofovir Disoproxil Fumarate
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
Safety: Percentage of participants with adverse events [ Time Frame: Up to 36 weeks (scheduled visits at Baseline; at Weeks 1, 2, 3, 5, 7, 9 and 12 during treatment; then at Weeks 16, 20, 24, 28, 32, and 36 during follow-up) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Efficacy: Percentage of participants with HBsAg seroconversion (antibody to HBsAg [anti-HBs] positive status and loss of HBsAg) 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 ] [ Designated as safety issue: No ]
Efficacy: Percentage of participants with HBsAg seroconversion (anti-HBs positive status and loss of HBsAg) 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 ] [ Designated as safety issue: No ]
Efficacy: Percentage of participants with HBeAg seroconversion (antibody to HBeAg [anti-HBe] positive status and loss of HBeAg) 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 ] [ Designated as safety issue: No ]
Efficacy: Percentage of participants with HBeAg seroconversion (anti-HBe positive status and loss of HBeAg) 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 ] [ Designated as safety issue: No ]
Pharmacokinetics: Maximum observed plasma concentration (Cmax) of RO6864018 metabolite in every other day (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 ] [ Designated as safety issue: No ]
Pharmacokinetics: Cmax of RO6864018 metabolite in every week (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Estimated Enrollment: 40
Study Start Date: May 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)