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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02579382




Registration number
NCT02579382
Ethics application status
Date submitted
15/10/2015
Date registered
19/10/2015

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
Secondary ID [1] 0 0
2015-002017-30
Secondary ID [2] 0 0
GS-US-283-1062
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TDF
Treatment: Drugs - Vesatolimod
Treatment: Drugs - Placebo

Placebo comparator: TDF + placebo - Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Experimental: TDF + Vesatolimod 1 mg - Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Experimental: TDF + Vesatolimod 2 mg - Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.

Experimental: TDF + Vesatolimod 4 mg - Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.

Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144.


Treatment: Drugs: TDF
300 mg tablets administered orally once daily

Treatment: Drugs: Vesatolimod
Tablets administered orally once a week (every 7 days) for 12 doses

Treatment: Drugs: Placebo
Placebo administered orally once a week (every 7 days) for 12 doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
Timepoint [1] 0 0
Baseline; Week 24
Secondary outcome [1] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
Timepoint [5] 0 0
Baseline; Week 12
Secondary outcome [6] 0 0
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
Timepoint [6] 0 0
Baseline; Week 48
Secondary outcome [7] 0 0
Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
Timepoint [7] 0 0
Baseline to Week 12
Secondary outcome [8] 0 0
Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
Percentage of Participants With a = 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
Timepoint [9] 0 0
Baseline to Week 48
Secondary outcome [10] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
Timepoint [10] 0 0
Week 24
Secondary outcome [11] 0 0
Percentage of Participants With HBV DNA < LLOQ at Week 48
Timepoint [11] 0 0
Week 48
Secondary outcome [12] 0 0
Percentage of Participants Experiencing Virologic Breakthrough
Timepoint [12] 0 0
Weeks 24 and 48
Secondary outcome [13] 0 0
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
Timepoint [13] 0 0
Baseline; Week 48
Secondary outcome [14] 0 0
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
Timepoint [14] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [15] 0 0
PK Parameter: AUCinf of Vesatolimod
Timepoint [15] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [16] 0 0
PK Parameter: %AUCexp of Vesatolimod
Timepoint [16] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [17] 0 0
PK Parameter: Cmax of Vesatolimod
Timepoint [17] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [18] 0 0
PK Parameter: Clast of Vesatolimod
Timepoint [18] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [19] 0 0
PK Parameter: Tmax of Vesatolimod
Timepoint [19] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [20] 0 0
PK Parameter: Tlast of Vesatolimod
Timepoint [20] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [21] 0 0
PK Parameter: T1/2 of Vesatolimod
Timepoint [21] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Secondary outcome [22] 0 0
PK Parameter: CL/F of Vesatolimod
Timepoint [22] 0 0
Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose

Eligibility
Key inclusion criteria
Key

* Adult males or females between the ages of 18-65
* Chronic hepatitis B virus (HBV) infection
* HBV deoxyribonucleic acid (DNA ) = 2000 IU/mL at screening

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Extensive bridging fibrosis or cirrhosis
* Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)
* Chronic liver disease other than HBV
* Lactating or pregnant females or those that wish to become pregnant during the course of the study

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2019
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
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
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Hong Kong
State/province [8] 0 0
Kowloon
Country [9] 0 0
Italy
State/province [9] 0 0
Bologna
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Italy
State/province [11] 0 0
Pisa
Country [12] 0 0
Italy
State/province [12] 0 0
San Giovanni Rotondo
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Daegu
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
Taiwan
State/province [16] 0 0
Dalin
Country [17] 0 0
Taiwan
State/province [17] 0 0
Kaohsiung
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT02579382