HCV InfectionPhase 1NCT01193478
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
A Phase 1 study testing GS-5885 in people with HCV Infection, run by Gilead Sciences at 13 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HCV Infection
- What is being tested?
- GS-5885
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2010to Dec 2011
- 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
- Chronically infected with HCV genotype 1
- HCV treatment-naïve
- Not co-infected with HIV or HBV
- HCV RNA viral load of at least 100,000 IU/mL
- BMI 19 to 35 kg/m2
- Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
Who cannot join
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Anaheim, California, 92801
Study site
Cypress, California, 90630
Study site
DeLand, Florida, 32720
Study site
Houston, Texas, 77030
Study site
Miami, Florida, 33169
Study site
National City, California, 91950
Study site
Orlando, Florida, 32809
Study site
Philadelphia, Pennsylvania, 19139
Study site
Portland, Oregon, 97239
Study site
San Antonio, Texas, 78215
Study site
St Louis, Missouri, 63104
Study site
Tacoma, Washington, 98418
Study site
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.
- Conditions
- HCV Infection
- Being tested
- GS-5885, Placebo
- Keywords
- Hepatitis C, HCV RNA, multiple ascending dose, NS5A, GS-5885, chronic genotype 1 HCV infection
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5885Drug
tablet, oral, 3 mg once daily for 3 days
PlaceboDrug
tablet, oral, once daily for 3 days
GS-5885Drug
tablet, oral, 10 mg once daily for 3 days
PlaceboDrug
tablet, oral, once daily for 3 days
GS-5885Drug
tablet, oral, 30 mg once daily for 3 days
PlaceboDrug
tablet, oral, once daily for 3 days
GS-5885Drug
tablet, oral, up to 90 mg once daily for 3 days
PlaceboDrug
tablet, oral, once daily for 3 days
GS-5885Drug
tablet, oral, up to 90 mg once daily for 3 days
PlaceboDrug
tablet, oral, once daily for 3 days
GS-5885Drug
tablet, oral, up to 90 mg once daily for 3 days
PlaceboDrug
tablet, oral, once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | GS-5885 (3 mg), once daily or matching placebo, once daily Receives: Drug: GS-5885; Drug: Placebo |
| Cohort 2 | Active comparator | GS-5885 (10 mg), once daily or matching placebo, once daily Receives: Drug: GS-5885; Drug: Placebo |
| Cohort 3 | Active comparator | GS-5885 (30 mg), once daily or matching placebo, once daily Receives: Drug: GS-5885; Drug: Placebo |
| Cohort 4 | Active comparator | GS-5885 ( up to 90 mg), once daily or matching placebo, once daily Receives: Drug: GS-5885; Drug: Placebo |
| Cohort 5 | Active comparator | GS-5885 (up to 90 mg), once daily or matching placebo, once daily Receives: Drug: GS-5885; Drug: Placebo |
| Cohort 6 (optional) | Active comparator | GS-5885 (up to 90 mg), once daily or matching placebo, once daily Receives: Drug: GS-5885; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting an adverse event or experiencing a laboratory abnormality
Measured: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline
Measured: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Secondary outcomes (2)
Measure of GS-5885 plasma concentration over time
Measured: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Emergence of viral resistance
Measured: Up to 48 weeks following Study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionDec 2011
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 HCV InfectionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Brainard, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193478
- Sponsor's protocol ID
- GS-US-256-0102
- Status last verified
- Jan 2013
- First submitted
- 31 Aug 2010
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wong KA, Worth A, Martin R, Svarovskaia E, Brainard DM, Lawitz E, Miller MD, Mo H. Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Antimicrob Agents Chemother. 2013 Dec;57(12):6333-40. doi: 10.1128/AAC.02193-12. Epub 2013 Jul 22.
PubMed 23877691
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01193478
- Acronym / sponsor ID
- GS-US-256-0102
- Conditions
- HCV Infection
- Keywords
- Hepatitis C, HCV RNA, multiple ascending dose, NS5A, GS-5885, chronic genotype 1 HCV infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Sep 2010 (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.
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: GS-5885, Drug: PlaceboGS-5885 (3 mg), once daily or matching placebo, once daily |
| Cohort 2 | Active comparator | Drug: GS-5885, Drug: PlaceboGS-5885 (10 mg), once daily or matching placebo, once daily |
| Cohort 3 | Active comparator | Drug: GS-5885, Drug: PlaceboGS-5885 (30 mg), once daily or matching placebo, once daily |
| Cohort 4 | Active comparator | Drug: GS-5885, Drug: PlaceboGS-5885 ( up to 90 mg), once daily or matching placebo, once daily |
| Cohort 5 | Active comparator | Drug: GS-5885, Drug: PlaceboGS-5885 (up to 90 mg), once daily or matching placebo, once daily |
| Cohort 6 (optional) | Active comparator | Drug: GS-5885, Drug: PlaceboGS-5885 (up to 90 mg), once daily or matching placebo, once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronically infected with HCV genotype 1
- HCV treatment-naïve
- Not co-infected with HIV or HBV
- HCV RNA viral load of at least 100,000 IU/mL
- BMI 19 to 35 kg/m2
Key exclusion criteria (4 listed)
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse
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-5885tablet, oral, 3 mg once daily for 3 days | Drug | Cohort 1 |
| Placebotablet, oral, once daily for 3 days | Drug | Cohort 1 |
| GS-5885tablet, oral, 10 mg once daily for 3 days | Drug | Cohort 2 |
| Placebotablet, oral, once daily for 3 days | Drug | Cohort 2 |
| GS-5885tablet, oral, 30 mg once daily for 3 days | Drug | Cohort 3 |
| Placebotablet, oral, once daily for 3 days | Drug | Cohort 3 |
| GS-5885tablet, oral, up to 90 mg once daily for 3 days | Drug | Cohort 4 |
| Placebotablet, oral, once daily for 3 days | Drug | Cohort 4 |
| GS-5885tablet, oral, up to 90 mg once daily for 3 days | Drug | Cohort 5 |
| Placebotablet, oral, once daily for 3 days | Drug | Cohort 5 |
| GS-5885tablet, oral, up to 90 mg once daily for 3 days | Drug | Cohort 6 (optional) |
| Placebotablet, oral, once daily for 3 days | Drug | Cohort 6 (optional) |
Primary outcome
Number of subjects reporting an adverse event or experiencing a laboratory abnormality
Time frame: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline
Time frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
2 secondary outcomes
Measure of GS-5885 plasma concentration over time
Time frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days
Emergence of viral resistance
Time frame: Up to 48 weeks following Study Day 14
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 21 Jan 2013.
- Derived from this study: PubMed 23877691Wong KA, Worth A, Martin R, Svarovskaia E, Brainard DM, Lawitz E, Miller MD, Mo H. Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Antimicrob Agents Chemother. 2013 Dec;57(12):6333-40. doi: 10.1128/AAC.02193-12. Epub 2013 Jul 22.
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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.
Diana Brainard, MD study director
Gilead Sciences
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-5885 in people with HCV Infection, run by Gilead Sciences at 13 sites in United States.
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 6 inclusion and 4 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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
Number of subjects reporting an adverse event or experiencing a laboratory abnormality (time frame: Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days). The study lists 2 primary outcomes in all. 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 NCT01193478, 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 21 Jan 2013.