Hepatitis C Virus InfectionPhase 3NCT03074331

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

A Phase 3 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 16 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults 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: 130 participants
Where: 16 sitesIndia
Study dates: 23 Mar 2017to 7 Feb 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 detected at screening
Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced.
Cirrhosis determination (approximately 20% may have cirrhosis)
Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day 1 prior to enrollment.

Show all 9Show fewer

Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the study protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Who cannot join

Current or prior history of any of the following:
Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Liver transplantation
Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening for those with cirrhosis) or current malignancy for which the patient is receiving treatment or which may interfere with individual's treatment, assessment or compliance with the protocol.
Screening laboratory parameters outside of defined threshold

Show all 12Show fewer

Prior exposure to HCV NS5A inhibitor
Pregnant or nursing female
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Use of any prohibited concomitant medications as described in study protocol
Known hypersensitivity to VEL, SOF, or formulation excipients
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

India16 sites

Post Graduate Institute of Medical Education and Resesarch (PGIMER)
Chandigarh, Punjab, 160012
YRG Care
Chennai, Tamil Nadu, 600010
VGM Hospital - Institute of Gastroenterology
Coimbatore, Tamil Nadu, 641005
All India Institute of Medical Sciences
Delhi, New Delhi, 110029
Institute of Digestive and Liver Disease
Guwahati, 781006
Global Hospitals
Hyderabad, 500004
Lakeshore Hospital
Kochi, 682040
Department of Hepatology, School of Digestive and Liver Diseases
Kolkata, West Bengal, 700020
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
Dayanand Medical College & Hospital
Ludhiana, 141001
Seth GS Medical College and KEM hospital
Mumbai, Maharashtra, 400012
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
Mumbai, Parel, 400012
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, 440003
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Gandhi Hospital
Secunderabad, Telangana, 500003
Nirmal Hospital
Surat, 395002

Other trials in India

About this study

Official title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects 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 Epclusa®, GS-7977/GS-5816
400/100 mg FDC tablet(s) administered orally once daily

Study groups in NCT03074331
Study group	Role	What they receive
SOF/VEL	Experimental	SOF/VEL 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 Week 12

Secondary outcomes (1)

Percentage of Participants With Virologic Failure
Virologic failure was defined as the following:
- On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or
- Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment.
Measured: Up to Posttreatment Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 20177 Feb 2018

First posted8 Mar 2017
Study start23 Mar 2017
Primary completion7 Feb 2018
Study completion7 Feb 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.
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: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03074331
Sponsor's protocol ID: GS-US-342-1521
Status last verified: Feb 2019
First submitted: 24 Feb 2017
Last updated: 19 Mar 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer

All Hepatitis C Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection
ClinicalTrials.gov ID: NCT03074331
Acronym / sponsor ID: GS-US-342-1521
Conditions: Hepatitis C Virus Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 23 Mar 2017 (actual)
Primary completion: 7 Feb 2018 (actual)
Study completion: 7 Feb 2018 (actual)
First posted: 8 Mar 2017 (actual)
Results: Posted 19 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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 (9 listed)

Willing and able to provide written informed consent
HCV RNA detected at screening
Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
Classification as treatment naïve or treatment experienced. Approximately 20% may be treatment-experienced.
Cirrhosis determination (approximately 20% may have cirrhosis)

Key exclusion criteria (12 listed)

Current or prior history of any of the following:
Screening laboratory parameters outside of defined threshold
Prior exposure to HCV NS5A inhibitor
Pregnant or nursing female
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

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: Epclusa®, GS-7977/GS-5816400/100 mg FDC tablet(s) 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 Week 12

1 secondary outcome

Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 12

Results and safety

Results posted to the registry on 19 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SOF/VEL 12 Weeks	130	123

Primary outcome: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Time frame: Posttreatment Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	SOF/VEL 12 Weeks n = 129
Value	93.0 (87.2 to 96.8)

SOF/VEL 12 Weeks: p = 0.009, 2-sided exact 1-sample binomial test

Population analysed: Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.

Primary outcome: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to Week 12. Number. Unit: percentage of participants

Measure	SOF/VEL 12 Weeks n = 129
Value	0

Population analysed: Safety Analysis Set included all participants who took at least 1 dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events: Up to 12 plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOF/VEL 12 Weeks	1 of 129 (0.8%)	0 of 129 (0%)	0 of 129

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Hepatitis C Virus Infection

Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer

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

16 sites in 1 country: 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 16 sites in India.

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 12 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in India. 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 19 Mar 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 NCT03074331.

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 19 Mar 2019.