Hepatitis C Virus InfectionPhase 2NCT02781558

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

A Phase 2 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 28 sites in Spain.

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) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis. 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 and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 28 sitesSpain
Study dates: 29 Jul 2016to 27 Oct 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

Willing and able to provide written informed consent
Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
Individuals with or without HIV-1 coinfection

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 active hepatitis B virus
Laboratory results outside the acceptable ranges at screening
Pregnant or nursing female
Chronic liver disease not caused by HCV
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

Spain28 sites

Hospital Universitario de A Coruña
A Coruña
Hospital Universitario Fundacion Alcorcon
Alcorcón
Hospital General Universitario De Alicante
Alicante
Complejo Hospitalario Torrecárdenas
Almería
Hospital Germans Trias i Pujol
Badalona
Hospital Universitario Valle Hebron
Barcelona, 8035
Hospital Clínic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí
Barcelona
Reina Sofía University Hospital
Córdoba
Hospital Universitario Donostia
Donostia / San Sebastian
Hospital Puerta De Hierro Majadahonda
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Universitario Virgen De La Arrixaca
Murcia
Hospital Universitario Central de asturias
Oviedo
Complexo Hospitalario Universitario de Montecelo
Pontevedra
Hospital Univ. NuestraSeñora Candelaria
Santa Cruz de Tenerife
Hospital Universitario Marques de Valdecilla
Santander, Cantabria
Hospital de Valme
Seville
Hospital Universitario Virgen Del Rocio
Seville
Hospital Clinico Universitario
Valencia
Hospital General Valencia
Valencia
La Fe Hospital
Valencia
Hospital Universitario Alvaro Cunqueiro
Vigo
Hospital Clinico Universitario
Zaragoza

Other trials in Spain

About this study

Official title: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

Conditions: Hepatitis C Virus Infection
Being tested: SOF/VEL, RBV
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®
400/100 mg FDC tablet administered orally once daily
RBVDrug
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT02781558
Study group	Role	What they receive
SOF/VEL	Experimental	SOF/VEL FDC for 12 weeks Receives: Drug: SOF/VEL
SOF/VEL + RBV	Experimental	SOF/VEL FDC + RBV for 12 weeks Receives: Drug: SOF/VEL; Drug: RBV

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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
Measured: Posttreatment Week 12

Secondary outcomes (14)

Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
Measured: Week 2
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
Measured: Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
Measured: Week 8
Percentage of Participants Who Have 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 8 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.

29 Jul 201627 Oct 2017

First posted24 May 2016 (estimated)
Study start29 Jul 2016
Primary completion6 Oct 2017
Study completion27 Oct 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02781558
Sponsor's protocol ID: GS-US-342-2097
Other IDs: 2016-000417-73, 2016
Status last verified: Oct 2018
First submitted: 20 May 2016
Last updated: 27 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

Esteban R, Pineda JA, Calleja JL, Casado M, Rodriguez M, Turnes J, Morano Amado LE, Morillas RM, Forns X, Pascasio Acevedo JM, Andrade RJ, Rivero A, Carrion JA, Lens S, Riveiro-Barciela M, McNabb B, Zhang G, Camus G, Stamm LM, Brainard DM, Subramanian GM, Buti M. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4. doi: 10.1053/j.gastro.2018.06.042. Epub 2018 Jun 27.
PubMed 29958855

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
ClinicalTrials.gov ID: NCT02781558
Acronym / sponsor ID: GS-US-342-2097
Conditions: Hepatitis C Virus Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 29 Jul 2016 (actual)
Primary completion: 6 Oct 2017 (actual)
Study completion: 27 Oct 2017 (actual)
First posted: 24 May 2016 (estimated)
Results: Posted 30 Oct 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SOF/VEL	Experimental	Drug: SOF/VELSOF/VEL FDC for 12 weeks
SOF/VEL + RBV	Experimental	Drug: SOF/VEL, Drug: RBVSOF/VEL FDC + RBV 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 (3 listed)

Willing and able to provide written informed consent
Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
Individuals with or without HIV-1 coinfection

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 active hepatitis B virus
Laboratory results outside the acceptable ranges at screening
Pregnant or nursing female
Chronic liver disease not caused by HCV

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®400/100 mg FDC tablet administered orally once daily	Drug	SOF/VEL, SOF/VEL + RBV
RBVRBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)	Drug	SOF/VEL + RBV

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; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event
Time frame: Posttreatment Week 12

14 secondary outcomes

Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants Who Have HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants Who Have HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants Who Have 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 30 Oct 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	101	98
SOF/VEL + RBV	103	101

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 = 101	SOF/VEL + RBV n = 103
Value	91.1 (83.8 to 95.8)	96.1 (90.4 to 98.9)

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

Primary outcome: Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event

Time frame: Posttreatment Week 12. Number. Unit: percentage of participants

Measure	SOF/VEL n = 101	SOF/VEL + RBV n = 103
Value	1.0	1.9

Population analysed: Safety Analysis Set

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	4 of 101 (4%)	24 of 101 (23.8%)	0 of 101
SOF/VEL + RBV	2 of 103 (1.9%)	55 of 103 (53.4%)	0 of 103

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29958855Esteban R, Pineda JA, Calleja JL, Casado M, Rodriguez M, Turnes J, Morano Amado LE, Morillas RM, Forns X, Pascasio Acevedo JM, Andrade RJ, Rivero A, Carrion JA, Lens S, Riveiro-Barciela M, McNabb B, Zhang G, Camus G, Stamm LM, Brainard DM, Subramanian GM, Buti M. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4. doi: 10.1053/j.gastro.2018.06.042. Epub 2018 Jun 27.
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

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 28 sites in Spain.

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 3 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 27 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 28 sites in Spain. 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 30 Oct 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 NCT02781558, 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 27 Nov 2018.