Hepatitis C Virus InfectionPhase 3NCT02671500
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
A Phase 3 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 38 sites in 5 countries.
Trial summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus Infection
- What is being tested?
- SOF/VEL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 19 Apr 2016to 27 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
- HCV treatment-naive or treatment-experienced
- Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
Who cannot join
- Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
China25 sites
Peking University First Hospital
Beijing, 100034
Peking University People's Hospital
Beijing, 100044
Beijing Friendship Hospital Affiliate of Capital Medical University
Beijing, 100050
Xiangyan Hospital, Central South University
Changsha, Hunan, 410008
Beijing Ditan Hospital
Chaoyang, Beijing Municipality, 100015
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
Guangzhou Eighth People's Hospital
Guangdong, 510060
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
The People's Hospital of Hainan Province
Hainan, 570311
Shanghai Public Health Clinical Center
Hongkou, Shanghai Municipality, 200083
Shanghai Ruijin Hospital
Huangpu, Shanghai Municipality, 200025
The 2nd Xiangya Hospital of Central South University
Hunan, 410011
The Second Hospital of Nanjing
Jiangsu, 210003
The First Hospital of Jilin University
Jilin City, 130021
Jinan Infectious Disease Hospital
Jinan, 250000
Shengjing Hospital of China Medical University
Liaoning, 110004
The First Affiliated Hospital of NanChang University
Nanchang, 330006
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200001
Shanghai Renji Hospital
Shanghai, 200001
The 3rd Hospital of Hebei Medical University
Shijiazhuang, 050051
Tongji Hospital Affiliated to Tongji Medicine University
Wuhan, Hubei, 430030
Henan Province People's Hospital
Zhengzhou, 450016
Thailand5 sites
Chulalongkorn Hospital
Bangkok, 10330
Ramathibodi Hospital Mahidol University
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
Maharaj Nakhon Chiangmai Hospital
Chiang Mai, 50202
Songklanagarind Hospital
Songkhla, 90110
Vietnam4 sites
Bach Mai Hospital
Hanoi, 100000
National Hospital for Tropical Disease
Hanoi, 100000
Ho Chi Minh City Hospital for Tropical Diseasees
Ho Chi Minh City, 700000
People's Hospital 115
Ho Chi Minh City, 700000
Malaysia2 sites
University of Malaya
Kuala Lumpur, 59100
Hospital Tengku Ampuan Afzan
Kuala Pahang, 25100
Singapore2 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
About this study
Official title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C Virus Infection
- Being tested
- SOF/VEL
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOF/VELDrug
Also called GS-7977/GS-5816, Epclusa®
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| SOF/VEL | Experimental | SOF/VEL FDC for 12 weeks Receives: Drug: SOF/VEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 12 weeks
Secondary outcomes (5)
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Measured: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ On Treatment
Measured: Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA
Measured: Baseline and up to Week 12
Percentage of Participants With Overall Virologic Failure
Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Measured: Up to Posttreatment Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start19 Apr 2016
- Primary completion5 Jan 2018
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671500
- Sponsor's protocol ID
- GS-US-342-1518
- Status last verified
- Dec 2018
- First submitted
- 29 Jan 2016
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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.
Publications
Lim SG, Rosmawati M, Phuong L, Hoi PT, McNabb BL, Lu S, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-6 HCV Infected Population from Singapore, Malaysia, Thailand, and Vietnam: Results from a Phase 3, Clinical Trial [Abstract 1094]. Hepatology 2017; 66 (1 Suppl): 586A.
Wei L, Xie Q, Huang Y, Wu S, Xu M, Tang H, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in Genotype 1-6 HCV-Infected Patients in China: Results from a Phase 3 Clinical Trial. [Abstract 637]. Hepatology 2018; 68 (1 Suppl): 379A.
Wei L, Lim SG, Xie Q, Van KN, Piratvisuth T, Huang Y, Wu S, Xu M, Tang H, Cheng J, Le Manh H, Gao Y, Mou Z, Sobhonslidsuk A, Dou X, Thongsawat S, Nan Y, Tan CK, Ning Q, Tee HP, Mao Y, Stamm LM, Lu S, Dvory-Sobol H, Mo H, Brainard DM, Yang YF, Dao L, Wang GQ, Tanwandee T, Hu P, Tangkijvanich P, Zhang L, Gao ZL, Lin F, Le TTP, Shang J, Gong G, Li J, Su M, Duan Z, Mohamed R, Hou JL, Jia J. Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):127-134. doi: 10.1016/S2468-1253(18)30343-1. Epub 2018 Dec 14.
PubMed 30555048
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
- ClinicalTrials.gov ID
- NCT02671500
- Acronym / sponsor ID
- GS-US-342-1518
- Conditions
- Hepatitis C Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOF/VEL | Experimental | Drug: SOF/VELSOF/VEL FDC for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
- HCV treatment-naive or treatment-experienced
Key exclusion criteria (5 listed)
- Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| SOF/VELAlso: GS-7977/GS-5816, Epclusa®SOF/VEL (400/100 mg) FDC tablet administered orally once daily | Drug | SOF/VEL |
Primary outcome
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 12 weeks
5 secondary outcomes
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Time frame: Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ On Treatment
Time frame: Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA
Time frame: Baseline and up to Week 12
Percentage of Participants With Overall Virologic Failure
Time frame: Up to Posttreatment Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationLim SG, Rosmawati M, Phuong L, Hoi PT, McNabb BL, Lu S, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-6 HCV Infected Population from Singapore, Malaysia, Thailand, and Vietnam: Results from a Phase 3, Clinical Trial [Abstract 1094]. Hepatology 2017; 66 (1 Suppl): 586A.
- Results publicationWei L, Xie Q, Huang Y, Wu S, Xu M, Tang H, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in Genotype 1-6 HCV-Infected Patients in China: Results from a Phase 3 Clinical Trial. [Abstract 637]. Hepatology 2018; 68 (1 Suppl): 379A.
- Derived from this study: PubMed 30555048Wei L, Lim SG, Xie Q, Van KN, Piratvisuth T, Huang Y, Wu S, Xu M, Tang H, Cheng J, Le Manh H, Gao Y, Mou Z, Sobhonslidsuk A, Dou X, Thongsawat S, Nan Y, Tan CK, Ning Q, Tee HP, Mao Y, Stamm LM, Lu S, Dvory-Sobol H, Mo H, Brainard DM, Yang YF, Dao L, Wang GQ, Tanwandee T, Hu P, Tangkijvanich P, Zhang L, Gao ZL, Lin F, Le TTP, Shang J, Gong G, Li J, Su M, Duan Z, Mohamed R, Hou JL, Jia J. Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):127-134. doi: 10.1016/S2468-1253(18)30343-1. Epub 2018 Dec 14.
- 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.
Gilead Study Director study director
Gilead Sciences
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 38 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 6 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 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in China, Thailand, Vietnam, Malaysia, Singapore. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). 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 NCT02671500, which also lists 3 linked publications.
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 8 Jan 2019.