A study to investigate whether RO707049389 is safe and how it is processed by the body, and its antiviral effect at different dose levels and in different population (healthy people, patients infected with hepatitis B virus and patients had chronic active hepatitis B)

A SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY STUDY OF RO7049389 IN: (1) SINGLE- (WITH OR WITHOUT FOOD) AND MULTIPLE- (WITH MIDAZOLAM) ASCENDING DOSES IN HEALTHY VOLUNTEERS; (2) PATIENTS CHRONICALLY INFECTED WITH HEPATITIS B VIRUS (3) PATIENTS WITH CHRONIC HEPATITIS B

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001139-30-BG

Enrollment

Registered

2019-05-17

Start date

2019-07-10

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B MedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: RO7049389 Product Code: Ro 7049389/F09 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N.A. CAS Number: 0467420-42-4 Current Sponsor code: RO7049389 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult male and female patients, 18 to 60 years of age, inclusive - Positive test for HBsAg or HBV DNA or positive HBeAg for more than 6 months prior to screening. - HbsAg >250 IU/mL at screening - For Cohorts only enrolling NUC-suppressed CHB patients (e.g., POM Cohort A), patients must qualify for the following criteria: a). Patients treated with a single NUC (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for =12 months. Patients must be on the same NUC therapy for at least 3 months before screening. b). At least one result showed HBV DNA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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. - one or more of the following laboratory abnormalities at screening: - Total serum bilirubin > ULN (exception Gilbert’s disease) - International normalized ratio (INR) >1.1 ULN. - Serum albumin ULN, absence of mass/findings suspicious for HCC must be demonstrated by ultrasound or CT or MRI within the screening period.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate anti-viral effect (functional cure) of treatment with RO7049389 on top of Standard of Care. Functional cure is defined as HBV DNA < lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (<0.05 international unit/milliliter (IU/mL)) at 24 weeks post-treatment ;Secondary Objective: - To further characterize the efficacy profile of RO7049389 on top of Standard of Care over time, including HBsAg loss, HBsAg seroconversion, quantitative HBsAg change from baseline, HBeAg loss, HBeAg seroconversion, quantitative HBeAg change from baseline, HBV DNA < LLOQ, HBV DNA change from baseline in different proof of mechanism (POM) cohorts of Part 3 and in subgroups of baseline HBeAg +/- patients, or of baseline high / low HBsAg level patients. - To characterize the plasma PK profiles of RO7049389 and its metabolites. - To assess the long-term safety and tolerability of RO7049389 on top of SoC (a NUC with or without Peg-IFN). ;Primary end point(s): Proportion of patients achieving functional cure (HBV DNA <LLOQ with HBsAg loss at 24 weeks post-treatment);Timepoint(s) of evaluation of this end point: 24 weeks post-treatment	—

Measure

Time frame

Main Objective: To evaluate anti-viral effect (functional cure) of treatment with RO7049389 on top of Standard of Care. Functional cure is defined as HBV DNA < lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (<0.05 international unit/milliliter (IU/mL)) at 24 weeks post-treatment ;Secondary Objective: - To further characterize the efficacy profile of RO7049389 on top of Standard of Care over time, including HBsAg loss, HBsAg seroconversion, quantitative HBsAg change from baseline, HBeAg loss, HBeAg seroconversion, quantitative HBeAg change from baseline, HBV DNA < LLOQ, HBV DNA change from baseline in different proof of mechanism (POM) cohorts of Part 3 and in subgroups of baseline HBeAg +/- patients, or of baseline high / low HBsAg level patients. - To characterize the plasma PK profiles of RO7049389 and its metabolites. - To assess the long-term safety and tolerability of RO7049389 on top of SoC (a NUC with or without Peg-IFN). ;Primary end point(s): Proportion of patients achieving functional cure (HBV DNA <LLOQ with HBsAg loss at 24 weeks post-treatment);Timepoint(s) of evaluation of this end point: 24 weeks post-treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients with HBsAg loss, HBsAg seroconversion, HBeAg loss, HBeAg seroconversion.;Timepoint(s) of evaluation of this end point: Week 12, 24, 36 and week 48 during treatment, 24 week post treatment	—

Countries

Bulgaria, Hong Kong, Korea, Republic of, New Zealand, Romania, Singapore, Taiwan, Thailand

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd.

global.rochegenentechtrials@roche.com+4161 688 1111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026