A study to understand the safety and effectiveness of switching from an existing drug called Viread to a new drug called TAF for the treatment of long term hepatitis B infectio

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: EUCTR2016-003632-20-IT
• Lead Sponsor: GILEAD SCIENCES INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-30
• Study Start: 2021-02-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

1) Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of
study procedures
2)Adult male and non-pregnant, non-lactating female subjects, =18 years of age based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential
3) Documented evidence of chronic HBV infection previously (e.g., documented HBsAg positive for more than 6 months)
4) Maintained on TDF 300 mg QD for at least 48 weeks, and as monotherapy for CHB for at least 24 weeks prior to screening and with viral suppression (HBV DNA < LLOQ by local laboratory assessment) for a minimum of 12 weeks prior to Screening, and including a Screening HBV DNA value of < 20 IU/mL (by central laboratory). The assay that will be used to quantify HBV DNA in Study GS-US-320-4018 is the Roche COBAS Ampliprep-COBAS TaqMan Hepatitis B Test v2.0
5) Estimated creatinine clearance = 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the Screening evaluation
6) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
7) Must be willing and able to comply with all study requirements
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 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 184

Exclusion Criteria

1) Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
2) Males and females of reproductive potential who are unwilling to use an effective”, protocol-specified method(s) of contraception during the study.
3) Co-infection with HCV, HDV, HIV
-Subjects who are HCV positive, but have a documented negative HCV RNA, are eligible
4)Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging)
5) Current evidence of, or recent (= 5 year) history of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
6) Abnormal hematological and biochemical parameters
7) Received solid organ or bone marrow transplant
8) Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
9) Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection
(e.g. basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
10) Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of
modifying renal excretion
11) Known hypersensitivity to study drugs, metabolites, or formulation excipients
12) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
13) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
14) Use of investigational agents within 3 months of Screening, unless allowed by the Sponsor
15) Use of any prohibited medications. Subjects on prohibited medications, who are otherwise eligible, will need a wash out period of at least 30 days prior to the Baseline visit.

Study & Design

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