Hepatitis C Virus InfectionPhase 2NCT02781571

Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

A Phase 2 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in 3 countries.

Completed

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

Official record

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Trial summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant. 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: 79 participants
Where: 15 sitesin 3 countries
Study dates: 27 Jul 2016to 28 Jul 2017
Phase: Phase 2
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

History of chronic HCV infection (≥ 6 months)
HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
Liver transplant ≥ 3 months prior to screening
Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Who cannot join

History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
Co-infection with HIV or hepatitis B virus
Known hypersensitivity to study medication,
Use of any prohibited concomitant medications as within with window before the Day 1 visit.
De novo or recurrent hepatocellular carcinoma posttransplant
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

15 sites in 3 countries.

Country

City, postcode or hospital

15 sites in 3 countries

Spain8 sites

Hospital Clínic de Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Reina Sofía University Hospital
Córdoba
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Ramón Y Cajal
Madrid
Hospital Universitario Virgen del Rocío
Seville
La Fe Hospital
Valencia
Hospital Clinico Zaragoza
Zaragoza

Other trials in Spain

United Kingdom5 sites

Cambridge University Hospitals NHS Foundation Trust
Cambridge
Royal Infirmary of Edinburgh
Edinburgh
St James University Hospital
Leeds
Kings College Hospital
London
Royal Free Hampstead NHS Trust
London

Other trials in United Kingdom

Switzerland2 sites

Universität Bern
Bern
University Hospital Zurich
Zurich

Other trials in Switzerland

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant

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 tablet administered orally once daily

Study groups in NCT02781571
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 Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Measured: Up to 12 weeks

Secondary outcomes (14)

Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation 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 HCV RNA < LLOQ at Week 2
Measured: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Measured: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Measured: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Measured: Week 12
HCV RNA at Week 2
Measured: Week 2
HCV RNA at Week 4
Measured: Week 4
HCV RNA at Week 8
Measured: Week 8
HCV RNA at Week 12
Measured: Week 12
Change From Baseline in HCV RNA at Week 2
Measured: Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Measured: Baseline; Week 4
Change From Baseline in HCV RNA at Week 8
Measured: Baseline; Week 8
Change From Baseline in HCV RNA at Week 12
Measured: Baseline; Week 12
Percentage of Participants With Virologic Failure
Virologic failure was defined as
On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements 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 12 weeks of treatment)
Virologic relapse:
- HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement
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.

27 Jul 201628 Jul 2017

First posted24 May 2016 (estimated)
Study start27 Jul 2016
Primary completion28 Jul 2017
Study completion28 Jul 2017

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 (1)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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02781571
Sponsor's protocol ID: GS-US-342-2104
Other IDs: 2016-000416-15, 2016
Status last verified: Jul 2018
First submitted: 20 May 2016
Last updated: 14 Nov 2018
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

Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Marino Z, Dufour JF, Forns X. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 2018 Sep;69(3):603-607. doi: 10.1016/j.jhep.2018.05.039. Epub 2018 Jun 8.
PubMed 29886154

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

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant
ClinicalTrials.gov ID: NCT02781571
Acronym / sponsor ID: GS-US-342-2104
Conditions: Hepatitis C Virus Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 27 Jul 2016 (actual)
Primary completion: 28 Jul 2017 (actual)
Study completion: 28 Jul 2017 (actual)
First posted: 24 May 2016 (estimated)
Results: Posted 21 Aug 2018

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 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 (4 listed)

History of chronic HCV infection (≥ 6 months)
HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
Liver transplant ≥ 3 months prior to screening
Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key exclusion criteria (6 listed)

History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
Co-infection with HIV or hepatitis B virus
Known hypersensitivity to study medication,
Use of any prohibited concomitant medications as within with window before the Day 1 visit.
De novo or recurrent hepatocellular carcinoma posttransplant

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 tablet administered orally once daily	Drug	SOF/VEL

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Time frame: Up to 12 weeks

14 secondary outcomes

Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time frame: Week 12
HCV RNA at Week 2
Time frame: Week 2
HCV RNA at Week 4
Time frame: Week 4
HCV RNA at Week 8
Time frame: Week 8
HCV RNA at Week 12
Time frame: Week 12
Change From Baseline in HCV RNA at Week 2
Time frame: Baseline; Week 2
Change From Baseline in HCV RNA at Week 4
Time frame: Baseline; Week 4
Change From Baseline in HCV RNA at Week 8
Time frame: Baseline; Week 8
Change From Baseline in HCV RNA at Week 12
Time frame: Baseline; Week 12
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 12

Results and safety

Results posted to the registry on 21 Aug 2018, 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	79	79

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

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

Measure	SOF/VEL n = 79
Value	96.2 (89.3 to 99.2)

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

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

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

Measure	SOF/VEL n = 79
Value	1.3

Population analysed: Safety Analysis Set: participants who took at least 1 dose if the study drug.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOF/VEL	3 of 79 (3.8%)	42 of 79 (53.2%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29886154Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Marino Z, Dufour JF, Forns X. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 2018 Sep;69(3):603-607. doi: 10.1016/j.jhep.2018.05.039. Epub 2018 Jun 8.
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

15 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in 3 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 4 inclusion and 6 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 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, United Kingdom, Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Aug 2018). 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 Cessation 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 NCT02781571, 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 14 Nov 2018.