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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Proportion of participants who remain HBsAg negative at Week 48
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
Timepoint [1] 0 0
Week 144
Secondary outcome [2] 0 0
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144
Timepoint [2] 0 0
Weeks 48, 144
Secondary outcome [3] 0 0
Proportion of participants who remain HBsAg negative at Week 144
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
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Proportions of participants with HBeAg loss and seroconversion at Week 144
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
Timepoint [6] 0 0
Week 48
Secondary outcome [7] 0 0
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144
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
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/08/2017
Sample size
Target
Accrual to date
Final
241
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/study/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/study/NCT02258581