Chronic Hepatitis B MedDRA version: 19.0 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Gilead Sciences International Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult subjects greater than or equal to 18 years of age HBeAg-negative at TDF therapy start CHB, HBsAg positive, HBeAg-negative, anti-HBe positive Received continuous TDF therapy treatment for at least 4 years prior to screening (i.e. TDF monotherapy or TDF + lamivudine or TDF + emtricitabine). If TDF has been used in combination with lamivudine or emtricitabine, lamivudine or emtricitabine must have been stopped at least 12 weeks prior to screening Documented HBV DNA =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known cirrhosis • Evidence of fibrosis greater than or equal to Stage 3 (METAVIR) on liver biopsy or Fibroscan > 10 kPa within 6 months prior to screening • History of decompensated liver disease (defined as direct [conjugated] bilirubin > 1.5 x ULN, PT > 1.5 x ULN, platelets < 75,000/mm³, serum albumin < 3.0 g/dL) • history of clinical hepatic decompensation • Evidence of hepatocellular carcinoma • Serological evidence of coinfection with HIV, HCV, or hepatitis D infection (HDV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate HBsAg loss and seroconversion in subjects who stop tenofovir disoproxil fumarate (TDF) (Arm A) compared to subjects who continue TDF (Arm B) ;Secondary Objective: The secondary objectives of this study are: • To characterize the restart of therapy in subjects who stop tenofovir disoproxil fumarate (TDF) (Arm A) • To evaluate HBV DNA suppression ( ULN) through Week 144 • To evaluate subjects’ safety through laboratory tests, vital signs and adverse events reporting We will also explore possible predictors of persistent virologic response. ;Primary end point(s): The primary endpoint is the proportion of subjects with HBsAg loss at Week 144 in both arms. ;Timepoint(s) of evaluation of this end point: Week 144 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HBsAg seroconversion is considered a secondary endpoint in supporting the primary objective, as seroconversion occurs following HBsAg loss. ;Timepoint(s) of evaluation of this end point: Weeks 48, 96 and 144 | — |
Countries
Germany
Contacts
Public ContactInternational Regulatory Affairs
Gilead Sciences International Ltd
Outcome results
None listed