Hepatitis CPhase 1NCT01591668
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
A Phase 1 study testing Single Ascending Dose Cohorts GS-9620 and Multiple Ascending Dose Cohorts GS-9620 in people with Hepatitis C, run by Gilead Sciences at 11 sites in 2 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 and/or days 8-10. Follow-up visits are also required periodically through day 43. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Single Ascending Dose Cohorts GS-9620 and Multiple Ascending Dose Cohorts GS-9620
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2012to Dec 2012
- 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
- Males and Females 18-65 years old
- Chronic HCV infection for at least 6 months, treatment naive
- HCV Viral load > 100,000 IU/mL at Screening
- Monoinfection with HCV 1 genotype
- Hepatitis B surface antigen negative
- Screening ECG without clinically significant abnormalities
Show all 9Show fewer
- BMI 18-33 kg/m^2
- Creatinine clearing > 70 mL/min
- Negative pregnancy test at screening
Who cannot join
- Pregnant or lactating subjects
- Co-infection with hepatitis B virus (HBV) or HIV
- History of Gilberts disease
- Particular abnormal laboratory parameters
- Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
- Evidence of hepatocellular carcinoma
- On-going alcohol abuse
- Positive uring drug screen
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Avail Clinical Research, LLC
DeLand, Florida, 32720
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Woodland International Research Group
Little Rock, Arkansas, 72211
CliniLabs
New York, New York, 10019
Orlando Clinical Research Center
Orlando, Florida, 32809
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Alamo Medical Research
San Antonio, Texas, 78215
CRI Worldwide, LLC
Willingboro, New Jersey, 08046
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C 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 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
- Conditions
- Hepatitis C
- Being tested
- Single Ascending Dose Cohorts GS-9620, Multiple Ascending Dose Cohorts GS-9620
- Keywords
- Hepatitis, Hepatitis C, Chronic HCV, HCV, Treatment Naive, Gilead, GS-9620
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Ascending Dose 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. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
Multiple Ascending Dose 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 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 Cohorts GS-9620 |
| 1mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose Cohorts GS-9620 |
| 2mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose Cohorts GS-9620 |
| 4mg GS-9620 | Experimental | Not described Receives: Drug: Single Ascending Dose Cohorts GS-9620 |
| 0.3mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose Cohorts GS-9620 |
| 1mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose Cohorts GS-9620 |
| 2mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose Cohorts GS-9620 |
| 4mg GS-9620 QW x 2 doses | Experimental | Not described Receives: Drug: Multiple Ascending Dose Cohorts GS-9620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events in single and multiple doses of GS-9620
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
Measured: Periodically Day 1 to 6 months
Secondary outcomes (3)
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Single ascending dose (SAD) 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.
Multiple ascending dose (MAD) cohorts: serial blood samples will 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-hour Post-dose, Day 2, Day 3, Day 5, 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 Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15
Measured: Days 1, 2, 3, 5, 8
Reduction of hepatitis C (HCV) RNA viral load from baseline
SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.
MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.
Measured: Screening, Baseline, Day 8 or 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591668
- Sponsor's protocol ID
- GS-US-243-0102
- Status last verified
- Aug 2013
- First submitted
- 23 Mar 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8.
PubMed 25105516
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 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 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01591668
- Acronym / sponsor ID
- GS-US-243-0102
- Conditions
- Hepatitis C
- Keywords
- Hepatitis, Hepatitis C, Chronic HCV, HCV, Treatment Naive, Gilead, GS-9620
- 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
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 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 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples 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 Cohorts GS-9620 |
| 1mg GS-9620 | Experimental | Drug: Single Ascending Dose Cohorts GS-9620 |
| 2mg GS-9620 | Experimental | Drug: Single Ascending Dose Cohorts GS-9620 |
| 4mg GS-9620 | Experimental | Drug: Single Ascending Dose Cohorts GS-9620 |
| 0.3mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose Cohorts GS-9620 |
| 1mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose Cohorts GS-9620 |
| 2mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose Cohorts GS-9620 |
| 4mg GS-9620 QW x 2 doses | Experimental | Drug: Multiple Ascending Dose Cohorts GS-9620 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and Females 18-65 years old
- Chronic HCV infection for at least 6 months, treatment naive
- HCV Viral load > 100,000 IU/mL at Screening
- Monoinfection with HCV 1 genotype
- Hepatitis B surface antigen negative
Key exclusion criteria (8 listed)
- Pregnant or lactating subjects
- Co-infection with hepatitis B virus (HBV) or HIV
- History of Gilberts disease
- Particular abnormal laboratory parameters
- Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
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 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. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). 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 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 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
Incidence of adverse events in single and multiple doses of GS-9620
Time frame: Periodically Day 1 to 6 months
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
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: Days 1, 2, 3, 5, 8
Reduction of hepatitis C (HCV) RNA viral load from baseline
Time frame: Screening, Baseline, Day 8 or 15
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 13 Aug 2013.
- Derived from this study: PubMed 25105516Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 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 Cohorts GS-9620 and Multiple Ascending Dose Cohorts GS-9620 in people with Hepatitis C, run by Gilead Sciences at 11 sites in 2 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 9 inclusion and 8 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 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Puerto Rico. 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?
Incidence of adverse events in single and multiple doses of GS-9620 (time frame: Periodically Day 1 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01591668, which also lists 1 linked publication.
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 13 Aug 2013.