Chronic Hepatitis B
Conditions
Keywords
prevention of chronic hepatitis B recurrence, post orthotopic liver transplant, prevention of chronic hepatitis B recurrence in patients who have undergone orthotopic liver transplant
Brief summary
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
Interventions
DRUGFTC/TDF
200/300 mg tablet administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study. * A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than two years post-menopausal). * All sexually active female individuals who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. * Male individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion. Note: Other protocol defined Inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Access to, and Received the Intervention | Up to 240 weeks | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the US. The first participant was screened on 06 Aug 2009. The last study visit occurred on 20 November 2015.
Pre-assignment details
51 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| FTC/TDF FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Investigators Discretion | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Safety or Tolerability Reasons | 4 |
Baseline characteristics
| Characteristic | FTC/TDF |
|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 10.52 |
| Race/Ethnicity, Customized Asian | 12 participants |
| Race/Ethnicity, Customized Black or American African | 5 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 participants |
| Race/Ethnicity, Customized Non-Hispanic/Latino | 20 participants |
| Race/Ethnicity, Customized Not Permitted | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 7 / 24 |
Outcome results
Primary
Number of Participants Who Had Access to, and Received the Intervention
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
Time frame: Up to 240 weeks
Population: Participants who were enrolled into the study and received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FTC/TDF | Number of Participants Who Had Access to, and Received the Intervention | 24 Participants |