Chronic Hepatitis CPhase 2SOF/VEL ESRDNCT03036852
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
A Phase 2 study testing SOF/VEL in people with Chronic Hepatitis C, run by Gilead Sciences at 22 sites in 6 countries.
Trial summary
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- 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
- 59 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 22 Mar 2017to 7 Nov 2018
- 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
- Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
United Kingdom7 sites
Gartnavel General Hospital
Glasgow, G12 0YN
Barts Health NHS Trust
London, E1 1BB
King's College Hospital
London, SE5 9RS
Chelsea and Westminster Hospital
London, SW10 9NH
Imperial College Healthcare NHS Trust
London, W2 1NY
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Derriford Hospital
Plymouth, PL6 8DH
Canada6 sites
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario
Kaye Edmonton Clinic
Edmonton, Alberta
Hamilton Health Sciences - McMaster University Medical Centre Site
Hamilton, Ontario, ON L8V
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec, H2X 3J4
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver, British Columbia, BC V5Z 1M9
Spain4 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, 28222
Hospital Universitario Virgen del Rocío
Seville, 41013
Israel3 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
The Chaim Sheba Medical Centre
Ramat Gan, 52173
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
- Conditions
- Chronic Hepatitis C
- Being tested
- SOF/VEL
- Medical subject headings
- Hepatitis C, Chronic
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 fixed-dose combination (FDC) tablet(s) administered orally once daily
| 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 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Measured: First dose date up to Week 12
Secondary outcomes (13)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.
Measured: Posttreatment Week 24
Change From Baseline in HCV RNA
Measured: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
Measured: Weeks 2, 4, 6, 8, and 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 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:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
Measured: Baseline to Posttreatment Week 24
Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.
Measured: First dose date up to Posttreatment Week 24
Pharmacokinetic (PK) Parameter: AUCtau of SOF
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of VEL
AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of SOF
Cmax is defined as the population PK derived maximum concentration of the drug.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
Cmax is defined as the population PK derived maximum concentration of the drug.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of VEL
Cmax is defined as the population PK derived maximum concentration of the drug.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Ctau of VEL
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
Measured: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start22 Mar 2017
- Primary completion13 Aug 2018
- Study completion7 Nov 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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies 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
- 59 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
- NCT03036852
- Sponsor's protocol ID
- GS-US-342-4062
- Other IDs
- 2016-003625-42, 2016
- Acronym
- SOF/VEL ESRD
- Status last verified
- Nov 2019
- First submitted
- 27 Jan 2017
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Publications
Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11.
PubMed 31195062
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. 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 for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT03036852
- Acronym / sponsor ID
- SOF/VEL ESRD / GS-US-342-4062
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 12 Nov 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 safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
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 (2 listed)
- Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key exclusion criteria (0 listed)
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 fixed-dose combination (FDC) tablet(s) administered orally once daily | Drug | SOF/VEL |
Primary outcome
Percentage of Participants With Sustained Virologic Response 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) 12 weeks after stopping the study treatment.
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Time frame: First dose date up to Week 12
13 secondary outcomes
Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
Time frame: Posttreatment Week 24
Change From Baseline in HCV RNA
Time frame: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Weeks 2, 4, 6, 8, and 12
Percentage of Participants With Virologic Failure
Time frame: Baseline to Posttreatment Week 24
Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
Time frame: First dose date up to Posttreatment Week 24
Pharmacokinetic (PK) Parameter: AUCtau of SOF
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of VEL
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of SOF
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of VEL
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Ctau of VEL
Time frame: Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationBorgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
- Derived from this study: PubMed 31195062Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11.
- 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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
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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
22 sites in 6 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 Chronic Hepatitis C, run by Gilead Sciences at 22 sites in 6 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 2 inclusion and 0 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Canada, Spain, Israel, Australia and 1 more country. 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 12 Nov 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 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 NCT03036852, which also lists 2 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 6 Mar 2020.