Hepatitis C Virus InfectionPhase 2NCT02350569

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

A Phase 2 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 6 sites in United States.

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 objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing… 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?: LDV/SOF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 6 sitesUnited States
Study dates: 22 May 2015to 22 Apr 2016
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 or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
HCV RNA infection with quantifiable virus at screening
Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
Currently on the liver transplantation wait list
Screening electrocardiogram (ECG) without clinically significant abnormalities.
A negative serum pregnancy test result is required for females

Who cannot join

Any previous solid organ transplant
Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
HIV infection or a positive hepatitis B virus surface antigen result
History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
Prior exposure to an HCV non-structural protein (NS)5A inhibitor

Show all 11Show fewer

Patients on hemodialysis prior to or at the time of transplantation will be excluded
Creatinine clearance (CLcr) < 40 mL/min at screening or < 40 mL/min on day of transplant
Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
Receipt or planned receipt of an organ from an HCV positive donor
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
San Francisco, California

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting

Conditions: Hepatitis C Virus Infection
Being tested: LDV/SOF
Keywords: liver transplant, hepatitis C, Gilead, Communicable Diseases, Infection, Liver Diseases, RNA Virus Infections
Medical subject headings: Hepatitis C, Communicable Diseases, Infections, Liver Diseases, RNA Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LDV/SOFDrug
Also called Harvoni®, GS-5885/GS-7977
90/400 mg FDC tablet administered orally

Study groups in NCT02350569
Study group	Role	What they receive
LDV/SOF	Experimental	Participants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant. Receives: Drug: LDV/SOF

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 Prematurely Discontinued Study Drug Due to an Adverse Event
Measured: Up to 4 weeks

Secondary outcomes (3)

Percentage of Participants With SVR 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 Virologic Failure
Virologic failure was defined as:
- End of treatment virologic failure:
- Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment
- Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement.
Measured: Up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
Measured: Days 1, 3, 5, 7, 14, 21, and 28

Timeline

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

22 May 201522 Apr 2016

First posted29 Jan 2015 (estimated)
Study start22 May 2015
Primary completion28 Mar 2016
Study completion22 Apr 2016

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: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02350569
Sponsor's protocol ID: GS-US-337-1428
Status last verified: Mar 2017
First submitted: 26 Jan 2015
Last updated: 19 Nov 2018
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 http://www.gilead.com/research/disclosure-and-transparency.

Publications

Levitsky J, Verna EC, O'Leary JG, Bzowej NH, Moonka DK, Hyland RH, Arterburn S, Dvory-Sobol H, Brainard DM, McHutchison JG, Terrault NA. Perioperative Ledipasvir-Sofosbuvir for HCV in Liver-Transplant Recipients. N Engl J Med. 2016 Nov 24;375(21):2106-2108. doi: 10.1056/NEJMc1611829. No abstract available.
PubMed 27959735

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 19 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 Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
ClinicalTrials.gov ID: NCT02350569
Acronym / sponsor ID: GS-US-337-1428
Conditions: Hepatitis C Virus Infection
Keywords: liver transplant, hepatitis C, Gilead, Communicable Diseases, Infection, Liver Diseases, RNA Virus Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 22 May 2015 (actual)
Primary completion: 28 Mar 2016 (actual)
Study completion: 22 Apr 2016 (actual)
First posted: 29 Jan 2015 (estimated)
Results: Posted 5 May 2017

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
LDV/SOF	Experimental	Drug: LDV/SOFParticipants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant.

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 or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
HCV RNA infection with quantifiable virus at screening
Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
Currently on the liver transplantation wait list
Screening electrocardiogram (ECG) without clinically significant abnormalities.

Key exclusion criteria (11 listed)

Any previous solid organ transplant
Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
HIV infection or a positive hepatitis B virus surface antigen result
History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date

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
LDV/SOFAlso: Harvoni®, GS-5885/GS-797790/400 mg FDC tablet administered orally	Drug	LDV/SOF

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 Prematurely Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 4 weeks

3 secondary outcomes

Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
Time frame: Days 1, 3, 5, 7, 14, 21, and 28

Results and safety

Results posted to the registry on 5 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LDV/SOF	16	16

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	Main Study (LDV/SOF 4 Weeks) n = 16
Value	87.5 (61.7 to 98.4)

Population analysed: Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug

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

Time frame: Up to 4 weeks. Number. Unit: percentage of participants

Measure	Main Study (LDV/SOF 4 Weeks) n = 16
Value	0

Population analysed: Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: LDV/SOF for 1 Day: After pre-dose to minimum of 30 days or restart of LDV/SOF; Main Study: After pretransplant dose up to 4 weeks plus 30 days; Retreatment: After pretransplant dose up to 12 weeks plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LDV/SOF for 1 Day	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Main Study (LDV/SOF 4 Weeks)	5 of 16 (31.3%)	14 of 16 (87.5%)	0 of 16
Retreatment (LDV/SOF 12 Weeks)	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27959735Levitsky J, Verna EC, O'Leary JG, Bzowej NH, Moonka DK, Hyland RH, Arterburn S, Dvory-Sobol H, Brainard DM, McHutchison JG, Terrault NA. Perioperative Ledipasvir-Sofosbuvir for HCV in Liver-Transplant Recipients. N Engl J Med. 2016 Nov 24;375(21):2106-2108. doi: 10.1056/NEJMc1611829. No abstract available.
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

6 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 LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 6 sites in United States.

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 11 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 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 6 sites in United States. 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 5 May 2017). 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 NCT02350569, 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 19 Nov 2018.