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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01671787
Registration number
NCT01671787
Ethics application status
Date submitted
21/08/2012
Date registered
24/08/2012
Date last updated
23/10/2018
Titles & IDs
Public title
A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
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Scientific title
A Phase 1b Randomized, Open Label, Active-Controlled Study to Assess the Safety, Viral Kinetics, and Anti-HBV Activity of GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B (CHB) Infection
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Secondary ID [1]
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GS-US-320-0101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GS-7340
Treatment: Drugs - Tenofovir disoproxil fumarate
Experimental: GS-7340 8mg - After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
Experimental: GS-7340 25mg - After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
Experimental: GS-7340 40mg - After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
Experimental: GS-7340 120mg - After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
Experimental: Tenofovir disoproxil fumarate 300mg - After Screening procedures, eligible subjects will be randomized 1:1:1:1:1 to receive either open-label GS-7340 8, 25, 40, or 120 mg (3 x 40 mg), or open-label TDF 300 mg for 28 days.
Treatment: Drugs: GS-7340
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Treatment: Drugs: Tenofovir disoproxil fumarate
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in serum hepatitis B virus (HBV) DNA
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Assessment method [1]
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Time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for GS-7340 8-, 25-, 40 and 120-mg.
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Timepoint [1]
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Up to Week 4
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Secondary outcome [1]
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Change in HBV DNA for tenofovir disoproxil fumarate (TDF)
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Assessment method [1]
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Comparing the short-term antiviral activity of GS-7340 with TDF 300mg. This is measured by time-weighted average change from baseline through Week 4 (DAVG4) in serum HBV DNA (log10 IU/mL) for TDF.
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Timepoint [1]
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Up to Week 4
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Secondary outcome [2]
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Change in HBV DNA of GS-7340 through 28 days of therapy
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Assessment method [2]
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Time weighted change from baseline to day 29 (DAVG4) in serum HBV DNA (log10 IU/mL)
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Timepoint [2]
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Up to week 4
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Secondary outcome [3]
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Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF
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Assessment method [3]
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GS-7340 and tenofovir (TFV) PK parameters in plasma will be calculated as applicable: Cmax, Tmax, Clast, Tlast, T1/2, ?z, AUC0-t, AUC0-last, AUC0-8, %AUCexp.
PK samples are collected on:
Baseline/Day 1: 0 (predose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post dose
Additional predose plasma samples will be collected on Days 2, 5, 8, 10, 15, 19, 22, and 29/End of Treatment.
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Timepoint [3]
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Up to week 4
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Secondary outcome [4]
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Safety and Tolerability of Therapy
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Assessment method [4]
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Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities
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Timepoint [4]
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Up to week 4
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Eligibility
Key inclusion criteria
- Must be between 18 and 65 years of age
- Must have Screening plasma HBV DNA = 2x10^3 IU/mL
- Must have chronic HBV infection for at least 6 months
- Must have estimated creatinine clearance (CLCr) = 70 mL/min
- Not pregnant or nursing
- Women must be of non-childbearing potential OR of childbearing potential with
confirmed negative pregnancy tests
- Consistent and correct use of recommended methods of birth control for men and women
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnant or lactating subjects
- Receipt of anti-HBV nucleoside/nucleotide therapy. Subjects who have failed prior
Interferon treatment, greater than 6 months prior to screening, are permitted to
participate in the study screening
- Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
- Presence of autoimmune disorders
- History of liver disease other than Hepatitis B
- History of Gilbert's Disease
- Any sign of decompensated liver disease
- Known or suspected cirrhosis
- Evidence of hepatocellular carcinoma
- Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac
conduction abnormalities
- Electrolyte abnormalities
- History of treatment that permanently alters the gastric condition
- Alcohol or substance abuse
- History of bleeding diathesis
- Significant bone disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2013
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Monash Medical Centre - Melborne
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Recruitment hospital [2]
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Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Austin Health - Melbourne
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Recruitment hospital [4]
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Linear Clinical Research Ltd - Nedlands
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Recruitment postcode(s) [1]
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03168 - Melborne
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Texas
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Canada
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British Columbia
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Country [6]
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Canada
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Ontario
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Country [7]
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Canada
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Quebec
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New Zealand
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Auckland
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United Kingdom
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Birmingham
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United Kingdom
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London
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Country [11]
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United Kingdom
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State/province [11]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil
fumarate (TDF).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01671787
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Flaherty, MD
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Address
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Gilead Sciences
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01671787
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