Hepatitis BPhase 1NCT01590641
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
A Phase 1 study testing Single Ascending Dose (SAD) Cohorts GS-9620 and Multiple Ascending Dose (MAD) Cohorts in people with Hepatitis B and HBV, run by Gilead Sciences at 23 sites in 5 countries.
Trial summary
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, HBV
- What is being tested?
- Single Ascending Dose (SAD) Cohorts GS-9620 and Multiple Ascending Dose (MAD) Cohorts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 23 sitesin 5 countries
- Study dates
- Apr 2012to Oct 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
- Chronic HBV infection ≥ 6 months
- HBsAg ≥ 250 IU/mL
- HBV treatment naïve
- Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis
- Creatinine clearance ≥ 70 mL/min
Who cannot join
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- History of Gilberts disease
- Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of hepatic decompensation
- Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease(COPD), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
- Evidence of hepatocellular carcinoma
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States13 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
West Coast Clinical Trials, LLC
Costa Mesa, California, 92626
Henry Ford Health System
Detroit, Michigan, 48202
Baylor College of Medicine
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202-5121
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Tulane University Health Sciences Center
New Orleans, Louisiana, 70122
Weill Cornell Medical College
New York, New York, 10021
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Mayo Clinic Hospital
Phoenix, Arizona, 85054
University of Utah
Salt Lake City, Utah, 84123
University of California Antiviral Research Center (AVRC)
San Diego, California, 92103
Australia4 sites
Monash University, Department of Medicine
Clayton, Victoria, 3168
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Nepean Hospital
Kingswood, New South Wales, 2747
Royal Perth Hospital
Nedlands, Western Australia, 6009
Canada3 sites
University of Calgary, Heritage Medical Research Center
Calgary, Alberta, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Algorithme Pharma, Inc.
Montreal, Quebec, H3P 3P1
South Korea2 sites
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B Virus Infection
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
- Conditions
- Hepatitis B, HBV
- Being tested
- Single Ascending Dose (SAD) Cohorts GS-9620, Multiple Ascending Dose (MAD) Cohorts
- Keywords
- Hepatitis, Hepatitis B, Hepatitis B Virus, HBV, GS-9620, Toll-like receptor (TLR)-7 Agonist
- Medical subject headings
- Hepatitis B, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Ascending Dose (SAD) Cohorts GS-9620Drug
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Multiple Ascending Dose (MAD) CohortsDrug
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses)
| Study group | Role | What they receive |
|---|---|---|
| 0.3mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 1mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 2mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 4mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 0.3mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose (MAD) Cohorts |
| 1mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose (MAD) Cohorts |
| 2mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose (MAD) Cohorts |
| 4mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose (MAD) Cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events in single and multiple oral doses of GS-9620
Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
Measured: Periodically Through Week 25
Secondary outcomes (3)
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Single ascending dose (SAD) and multiple ascending dose (MAD) Cohorts:serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.
MAD Cohorts: serial blood samples will also be collected on Day 8 at 0 (pre-dose), , 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Measured: Day 1 and Day 8
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
SAD Cohorts: whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: pre-dose and 8-hr post dose, Day 2, Day 3, Days 5 and Day 8
MAD Cohorts: whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: pre-dose and 8 hours postdose, Day 2, Day 3, Day 5, and Day 8: pre-dose and 8 hours post-dose, Day 9, Day 10, Day 12, and Day 15
Measured: Up to Day 15
Reduction of hepatitis B (HBV) viral load from baseline
Antiviral activity will be evaluated by determination of HBV HBsAg and HBV viral load kinetics
Measured: Up to Day 15 and Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benedetta Massetto, M.D., Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590641
- Sponsor's protocol ID
- GS-US-283-0106
- Status last verified
- Nov 2013
- First submitted
- 30 Apr 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B Virus Infection
- ClinicalTrials.gov ID
- NCT01590641
- Acronym / sponsor ID
- GS-US-283-0106
- Conditions
- Hepatitis B, HBV
- Keywords
- Hepatitis, Hepatitis B, Hepatitis B Virus, HBV, GS-9620, Toll-like receptor (TLR)-7 Agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 May 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.
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 0.3mg GS-9620 | Experimental | Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 1mg GS-9620 | Experimental | Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 2mg GS-9620 | Experimental | Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 4mg GS-9620 | Experimental | Drug: Single Ascending Dose (SAD) Cohorts GS-9620 |
| 0.3mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose (MAD) Cohorts |
| 1mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose (MAD) Cohorts |
| 2mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose (MAD) Cohorts |
| 4mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose (MAD) Cohorts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic HBV infection ≥ 6 months
- HBsAg ≥ 250 IU/mL
- HBV treatment naïve
- Absence of extensive bridging fibrosis (Metavir 3 or greater) or cirrhosis
- Creatinine clearance ≥ 70 mL/min
Key exclusion criteria (5 listed)
- Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV
- History of Gilberts disease
- Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of hepatic decompensation
- Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease(COPD), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed
- Evidence of hepatocellular carcinoma
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 |
|---|---|---|
| Single Ascending Dose (SAD) Cohorts GS-9620This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620. | Drug | 0.3mg GS-9620, 1mg GS-9620, 2mg GS-9620, 4mg GS-9620 |
| Multiple Ascending Dose (MAD) CohortsThis study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses) | Drug | 0.3mg GS-9620 QW x 2 doses, 1mg GS-9620 QW x 2 doses, 2mg GS-9620 QW x 2 doses, 4mg GS-9620 QW x 2 doses |
Primary outcome
Assessment of adverse events in single and multiple oral doses of GS-9620
Time frame: Periodically Through Week 25
Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
3 secondary outcomes
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Time frame: Day 1 and Day 8
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Time frame: Up to Day 15
Reduction of hepatitis B (HBV) viral load from baseline
Time frame: Up to Day 15 and Follow-Up
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 14 Nov 2013.
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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.
Benedetta Massetto, M.D. study director
Gilead Sciences
23 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 Single Ascending Dose (SAD) Cohorts GS-9620 and Multiple Ascending Dose (MAD) Cohorts in people with Hepatitis B and HBV, run by Gilead Sciences at 23 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 5 inclusion and 5 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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Australia, Canada, South Korea, 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?
Assessment of adverse events in single and multiple oral doses of GS-9620 (time frame: Periodically Through Week 25). 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 14 Nov 2013.