RecruitingPhase 1ACTRN12619000271101

RO7191863 in patients with chronic hepatitis B

An Observer-blind, Randomized Study with an Open-label Part to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of RO7191863 with Multiple Doses and Different Regimens in Virologically Suppressed Patients with Chronic Hepatitis B Infection

Sponsor

F. Hoffmann-La Roche

Enrollment

49 participants

Start Date

Mar 25, 2019

Study Type

Interventional

Conditions

Chronic Hepatitis B Infection

Summary

RO7191863 is being developed for the curative treatment of chronic hepatitis B virus (HBV) infection. This is the first study with RO7191863 in humans, designed to assess the safety, tolerability and pharmacokinetics of different doses in participants diagnosed with chronic hepatitis B (CHB).

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Chronic hepatitis B is a long-term viral infection of the liver that affects hundreds of millions of people worldwide. While existing antiviral medications can suppress the virus and prevent liver damage, they rarely achieve a complete cure — patients typically need to take medication indefinitely. RO7191863 is a new investigational drug being developed with the goal of achieving a functional cure by helping the immune system clear the virus. This is the first study of RO7191863 in humans. It is a Phase 1 trial designed to assess whether the drug is safe and how it moves through the body at different doses. Participants will already be on stable antiviral treatment (entecavir or tenofovir) with their hepatitis B virus well controlled, and will receive RO7191863 in addition to their existing medication. You may be eligible if you are between 18 and 65 years old, have had a confirmed diagnosis of chronic hepatitis B for at least 6 months, and have been on stable antiviral therapy with an undetectable viral load for at least 6 months. People with significant liver scarring or cirrhosis, other liver conditions, HIV, hepatitis C or D co-infection, a history of cancer, or immune-related disorders would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The study will be conducted in one (or potentially two) parts, Part A and Part B. The study drug of interest, RO7191863, will be administered via subcutaneous injection at an appropriate body site, e.g. abdomen or upper thigh at a dose of up to 3 mg/kg body weight (BW). The administration site will be rotated so that the nature of any injection site reactions may be better understood. Part A consists of 5 cohorts: MAD1: 0.4 mg/kg RO7191863 x 3 doses over 7 weeks MAD2: 1.2 mg/kg RO7191863 x 3 doses over 7 weeks MAD3: 1.2 mg/kg RO7191863 x 3 doses over 5 weeks MAD4: 1.2 mg/kg RO7191863 or placebo x 5 doses over 9 weeks MAD5: Maximum of 3.0 mg/kg RO7191863 or placebo x 5 doses over 9 weeks MAD5a (Potential cohort): RO7191863 x 5 doses over 9 weeks The increase of doses (from 0.4 to 1.2 mg/kg, and from 1.2 to 3.0 mg/kg body weight, respectively) will be informed by the safety data of the completed cohorts. This study consists of an optional sub-study, Fine Needle Aspirate (FNA) of the liver that may be offered to participants entering cohort MAD5 at one or more selected sites with established expertise. FNAs of the liver will be assessed to explore one or more intra-hepatic PD measures and potentially PK measures to explore the effects of RO7191863 in the target organ. A further cohort (MAD5a, following the same dosing schedule as in MAD5) may be opened if required to allow for the inclusion of additional participants into the FNA sub-study. Depending on the numbers enrolled in Part A of, e.g., female participants or HBeAg-positive participants, conduct of the corresponding optional Part B cohorts might be justified for the collection of additional safety data in these patient groups. Part B (potential): Two open-label MAD cohorts (MAD6, MAD7): anticipated dose level (3.0 mg/kg) once a week, ranging from 5 up to 12 doses. Participants must discontinue study treatment if there is non-compliance with study requirements as judged by the Investigator and in consultation with the Sponsor.