Chronic Hepatitis BPhase 1NCT01671787
A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B
A Phase 1 study testing GS-7340 and Tenofovir disoproxil fumarate in people with Chronic Hepatitis B, run by Gilead Sciences at 19 sites in 5 countries.
Trial summary
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- GS-7340 and Tenofovir disoproxil fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Canada5 sites
Algorithme Pharma
Montreal, Quebec, H3P3P1
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H8L6
Pro-recherche
Saint Romuald, Quebec, G6W 8H1
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Downtown Infectious Diseases Clinic (University of British Columbia)
Vancouver, British Columbia, V6Z2C9
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B152TH
Grahame Hayton Unit
London, E1 1BB
University College London Hospital
London, NW1-2BU
Institute of Liver Studies, King's College Hospital
London, SE5 9RS
Nottingham University Hospitals NHS Trust - Queens Medical Centre
Nottingham, NG7 2UH
United States4 sites
University of Maryland Institute of Human Virology
Baltimore, Maryland, 21201
Henry Ford Health System
Detroit, Michigan, 48202
Baylor College of Medicine - St. Luke's Episcopal Hospital
Houston, Texas, 77030
Research and Education Inc.
San Diego, California, 92105
Australia4 sites
Monash Medical Centre
Melborne, Victoria, 03168
Alfred Hospital
Melbourne, Victoria, 3004
Austin Health
Melbourne, Victoria, 3084
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official 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
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).
Read the detailed description
This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.
- Conditions
- Chronic Hepatitis B
- Being tested
- GS-7340, Tenofovir disoproxil fumarate
- Keywords
- Hepatitis B, HBV, GS-7340, TDF, Tenofovir disoproxil fumarate, Gilead, Viread
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-7340Drug
Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
Tenofovir disoproxil fumarateDrug
Also called Viread
Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
| Study group | Role | What they receive |
|---|---|---|
| GS-7340 8mg | Experimental | 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. Receives: Drug: GS-7340 |
| GS-7340 25mg | Experimental | 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. Receives: Drug: GS-7340 |
| GS-7340 40mg | Experimental | 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. Receives: Drug: GS-7340 |
| GS-7340 120mg | Experimental | 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. Receives: Drug: GS-7340 |
| Tenofovir disoproxil fumarate 300mg | Experimental | 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. Receives: Drug: Tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 4
Secondary outcomes (4)
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.
Measured: Up to Week 4
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)
Measured: Up to week 4
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, λz, AUC0-t, AUC0-last, AUC0-∞, %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.
Measured: Up to week 4
Safety and Tolerability of Therapy
Safety and tolerability is measured by the incidence of adverse events and graded laboratory abnormalities
Measured: Up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Flaherty, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671787
- Sponsor's protocol ID
- GS-US-320-0101
- Status last verified
- May 2014
- First submitted
- 21 Aug 2012
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01671787
- Acronym / sponsor ID
- GS-US-320-0101
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B, HBV, GS-7340, TDF, Tenofovir disoproxil fumarate, Gilead, Viread
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).
Detailed description
This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GS-7340 8mg | Experimental | Drug: GS-7340After 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. |
| GS-7340 25mg | Experimental | Drug: GS-7340After 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. |
| GS-7340 40mg | Experimental | Drug: GS-7340After 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. |
| GS-7340 120mg | Experimental | Drug: GS-7340After 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. |
| Tenofovir disoproxil fumarate 300mg | Experimental | Drug: Tenofovir disoproxil fumarateAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-7340Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy. | Drug | GS-7340 120mg, GS-7340 25mg, GS-7340 40mg, GS-7340 8mg |
| Tenofovir disoproxil fumarateAlso: VireadSubjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy | Drug | Tenofovir disoproxil fumarate 300mg |
Primary outcome
Change in serum hepatitis B virus (HBV) DNA
Time frame: Up to Week 4
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.
4 secondary outcomes
Change in HBV DNA for tenofovir disoproxil fumarate (TDF)
Time frame: Up to Week 4
Change in HBV DNA of GS-7340 through 28 days of therapy
Time frame: Up to week 4
Pharmacokinetics (PK) of GS-7340 and/or tenofovir (TVF) following single and multiple doses of GS-7340 and TDF
Time frame: Up to week 4
Safety and Tolerability of Therapy
Time frame: Up to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Flaherty, MD study director
Gilead Sciences
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-7340 and Tenofovir disoproxil fumarate in people with Chronic Hepatitis B, run by Gilead Sciences at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada, United Kingdom, United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum hepatitis B virus (HBV) DNA (time frame: Up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.