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)

Phase 1

• Conditions: Chronic Hepatitis B; MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-001139-30-BG
• Lead Sponsor: F. Hoffman-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-17
• Study Completion: 2022-03-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 192

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 <60 IU/mL at least 6 months prior to screening; and HBV DNA <20 IU/mL at screening by Roche Cobas assay. c). ALT =2 x ULN at screening and at Day -1 (can be checked by local lab result).

- For Cohorts only enrolling anti-HBV treatment-naïve and immune-active patients (e.g.,POM Cohort B and Cohort C), patients must qualify for the following criteria: a). Previous anti-HBV treatments for <30 days in total, and did not receive any anti-HBV treatments within 3 months prior to the first study dose. b). HBV DNA at screening =2 x 104 IU/mL for HBeAg positive patients, or ?2 x 103 IU/mL for HbeAg negative patients. c). ALT at screening between 1–5 x ULN and ALT <5 x ULN at Day -1 (can be checked by local lab result).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 < 3.0 g/dL (<30 g/L).
- Platelet count <140,000 cells/mm3
- Hemoglobin <12 g/dL (females) or <13 g/dL (males).
- White blood cell count <2500 cell/mm3.
- Neutrophil count <1500 cell/mm3 (<1200 cell/mm3 if considered a physiological variant in a patient of African descent).

- Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein (AFP) =100 mg/mL. If AFP >ULN, absence of mass/findings suspicious for HCC must be demonstrated by ultrasound or CT or MRI within the screening period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified