Trial Outcomes & Findings for Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver (NCT NCT01146808)

Results Overview

Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (\>40 IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Standard of care visits post-transplant for 2 years

Results posted on

2021-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	ADV Plus Hepatitis B Vaccination Group This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADV Plus Hepatitis B Vaccination Group n=16 Participants This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Standard of care visits post-transplant for 2 years

Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (\>40 IU/mL).

Outcome measures

Outcome measures
Measure	ADV Plus Hepatitis B Vaccination Group n=16 Participants This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver	5 Participants

SECONDARY outcome

Timeframe: 12-18 months post transplant

Outcome measures

Outcome measures
Measure	ADV Plus Hepatitis B Vaccination Group n=16 Participants This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination	2 Participants

SECONDARY outcome

Timeframe: Six months after hepatitis B vaccination (2 years post transplant)

Outcome measures

Outcome measures
Measure	ADV Plus Hepatitis B Vaccination Group n=16 Participants This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal	3 Participants

Adverse Events

ADV Plus Hepatitis B Vaccination Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert S. Brown Jr., MD, MPH

Columbia University Medical Center

Phone: (212) 305-3839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place