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Clinical Trials/EUCTR2019-001139-30-BG
EUCTR2019-001139-30-BG
Active, not recruiting
Phase 1

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

F. Hoffman-La Roche Ltd.0 sites192 target enrollmentMay 17, 2019
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ConditionsChronic Hepatitis BMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Hepatitis B
Sponsor
F. Hoffman-La Roche Ltd.
Enrollment
192
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 17, 2019
End Date
March 16, 2022
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
F. Hoffman-La Roche Ltd.

Eligibility 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 \<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

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).

Outcomes

Primary Outcomes

Not specified

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