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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02258581




Registration number
NCT02258581
Ethics application status
Date submitted
3/10/2014
Date registered
7/10/2014
Date last updated
3/10/2017

Titles & IDs
Public title
Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
Scientific title
A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection
Secondary ID [1] 0 0
2015-001050-16
Secondary ID [2] 0 0
GS-US-330-1508
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - GS-4774
Treatment: Drugs - GS-9620
Treatment: Drugs - Tenofovir disoproxil fumarate (TDF)

Treatment: Drugs: GS-4774
Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.

Treatment: Drugs: GS-9620
Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.

Treatment: Drugs: Tenofovir disoproxil fumarate (TDF)
Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline = 0.5 log10 IU/ml from baseline at Week 48 - This endpoint will be measured for participants who are HBsAg positive at baseline.
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Proportion of participants who remain HBsAg negative at Week 48 - This endpoint will be measured for participants who are HBsAg negative at baseline.
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Proportion of participants with serum HBsAg decline = 0.5 log10 IU/ml from baseline at Week 144 - This endpoint will be measured for participants who are HBsAg positive at baseline.
Timepoint [1] 0 0
Week 144
Secondary outcome [2] 0 0
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144 - This endpoint will be measured for participants who are HBsAg positive at baseline.
Timepoint [2] 0 0
Weeks 48, 144
Secondary outcome [3] 0 0
Proportion of participants who remain HBsAg negative at Week 144 - This endpoint will be measured for participants who are HBsAg negative at baseline.
Timepoint [3] 0 0
Week 144
Secondary outcome [4] 0 0
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48 - This endpoint will be measured for participants who are HBeAg positive at baseline.
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Proportions of participants with HBeAg loss and seroconversion at Week 144 - This endpoint will be measured for participants who are HBeAg positive at baseline.
Timepoint [5] 0 0
Week 144
Secondary outcome [6] 0 0
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48 - This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Timepoint [6] 0 0
Week 48
Secondary outcome [7] 0 0
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144 - This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Timepoint [7] 0 0
Week 144
Secondary outcome [8] 0 0
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 - This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.
Timepoint [8] 0 0
Weeks 48, 96 and 144
Secondary outcome [9] 0 0
Change from Baseline in HBV DNA at Weeks 48, 96, and 144
Timepoint [9] 0 0
Baseline; Week 48; Week 96; Week 144

Eligibility
Key inclusion criteria
Key

- Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more
than 120 days prior to Baseline (Day 1), except for participants from previous
Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their
last visit in that protocol.

- Must have the ability to understand and sign a written informed consent form, which
must be obtained prior to initiation of study procedures

- Must be willing and able to comply with the visit schedule and study requirements

- Must have documented HBV DNA < 2,000 IU/mL at time of screening visit, which shall
occur no later than 1 year post last study visit in GS-US-174-0149

- Must have documented hepatitis B surface antigen (HBsAg) negative status anytime
during participation in GS-US-174-0149 regardless of ongoing HBV treatment

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient participating or planning to participate in another clinical study with an
investigational agent

- History of clinically-significant illness or any other major medical disorder that may
interfere with follow-up, assessments or compliance with the protocol

- Believed by the Study Investigator to be inappropriate for study participation for any
reason not otherwise listed

- Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm)
or for TDF retreatment, and have taken any HBV antiviral therapy since completion of
GS-US-174-0149

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Hong Kong
State/province [16] 0 0
Lai Chi Kok
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Sha Tin
Country [18] 0 0
India
State/province [18] 0 0
Gurarat
Country [19] 0 0
India
State/province [19] 0 0
Maharashtra
Country [20] 0 0
India
State/province [20] 0 0
West Bengal
Country [21] 0 0
Italy
State/province [21] 0 0
Foggia
Country [22] 0 0
Italy
State/province [22] 0 0
Pisa
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Parma
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Busan
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the
HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only
individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
Trial website
https://clinicaltrials.gov/show/NCT02258581
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02258581