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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
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
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
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)
Drug: RO6864018
Drug: Tenofovir
Phase 2 |
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