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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
GS-US-320-0101
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 - 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

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

Outcomes
Primary outcome [1] 0 0
Change in serum hepatitis B virus (HBV) DNA - 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.
Timepoint [1] 0 0
Up to Week 4
Secondary outcome [1] 0 0
Change in HBV DNA for tenofovir disoproxil fumarate (TDF) - 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.
Timepoint [1] 0 0
Up to Week 4
Secondary outcome [2] 0 0
Change in HBV DNA of GS-7340 through 28 days of therapy - Time weighted change from baseline to day 29 (DAVG4) in serum HBV DNA (log10 IU/mL)
Timepoint [2] 0 0
Up to week 4
Secondary outcome [3] 0 0
Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF - 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.
Timepoint [3] 0 0
Up to week 4
Secondary outcome [4] 0 0
Safety and Tolerability of Therapy - Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities
Timepoint [4] 0 0
Up to week 4

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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
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)
VIC,WA
Recruitment hospital [1] 0 0
Monash Medical Centre - Melborne
Recruitment hospital [2] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Austin Health - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
03168 - Melborne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3084 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
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
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Birmingham
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Nottingham

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil
fumarate (TDF).
Trial website
https://clinicaltrials.gov/show/NCT01671787
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Flaherty, MD
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
Other publications