Hepatitis CPhase 2NCT01924949

Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

A Phase 2 study testing LDV/SOF in people with Hepatitis C, run by Gilead Sciences at 1 site in United States.

Completed

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

Trial summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 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
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: 5 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Aug 2014
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

Body mass index (BMI) greater than or equal to 18 kg/m^2.
HCV RNA greater than or equal to 1000 IU/mL at screening.
Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
Screening laboratory values within predefined thresholds.
Use of two effective contraception methods if female of childbearing potential or sexually active male.
Healthy according to medical history and physical examination with the exception of HCV diagnosis.

Who cannot join

Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
Prior exposure to an HCV NS5a inhibitor.
Pregnant or nursing female.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
History of solid organ transplantation.
Current or prior history of clinical hepatic decompensation.
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
Known hypersensitivity to LDV, SOF, or formulation excipients.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Boston, Massachusetts

Other trials in United States

About this study

Official title: An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection

Conditions: Hepatitis C
Being tested: LDV/SOF
Keywords: 7977, 5885, GS-7977, GS-5885, SOF, LDV, Sofosbuvir, Ledipasvir, FDC
Medical subject headings: Hepatitis C

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
Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily

Study groups in NCT01924949
Study group	Role	What they receive
LDV/SOF	Experimental	Participants will receive LDV/SOF FDC for 12 weeks. 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) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Measured: Posttreatment Week 12
Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
Measured: Up to 12 weeks

Secondary outcomes (4)

Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Measured: Up to 12 weeks
HCV RNA Change From Baseline
Measured: Baseline; Weeks 1, 4, and 8
Percentage of Participants Experiencing 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

Timeline

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

Jul 2013Aug 2014

First posted19 Aug 2013 (estimated)
Study startJul 2013
Primary completionMay 2014
Study completionAug 2014

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 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: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01924949
Sponsor's protocol ID: GS-US-337-0125
Status last verified: May 2015
First submitted: 14 Aug 2013
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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All Hepatitis C trials

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: An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection
ClinicalTrials.gov ID: NCT01924949
Acronym / sponsor ID: GS-US-337-0125
Conditions: Hepatitis C
Keywords: 7977, 5885, GS-7977, GS-5885, SOF, LDV, Sofosbuvir, Ledipasvir
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: May 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 19 Aug 2013 (estimated)
Results: Posted 29 May 2015

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 will receive LDV/SOF 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 (6 listed)

Body mass index (BMI) greater than or equal to 18 kg/m^2.
HCV RNA greater than or equal to 1000 IU/mL at screening.
Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
Screening laboratory values within predefined thresholds.
Use of two effective contraception methods if female of childbearing potential or sexually active male.

Key exclusion criteria (8 listed)

Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
Prior exposure to an HCV NS5a inhibitor.
Pregnant or nursing female.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
History of solid organ transplantation.

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-7977Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily	Drug	LDV/SOF

Primary outcome

Percentage of Participants With Sustained Virologic Response (SVR) at 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, 25 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
Time frame: Up to 12 weeks

4 secondary outcomes

Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Up to 12 weeks
HCV RNA Change From Baseline
Time frame: Baseline; Weeks 1, 4, and 8
Percentage of Participants Experiencing Virologic Failure
Time frame: Baseline to posttreatment Week 24

Results and safety

Results posted to the registry on 29 May 2015, 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 12 Weeks	5	5

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

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

Measure	LDV/SOF 12 Weeks n = 5
Value	100.0

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

Primary outcome: Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event

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

Measure	LDV/SOF 12 Weeks n = 5
Value	0

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

4 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
LDV/SOF 12 Weeks	1 of 5 (20%)	4 of 5 (80%)	Not reported

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.
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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
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
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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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.

Luisa Stamm, MD, PhD study director

Gilead Sciences

1 site 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, run by Gilead Sciences at 1 site 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 8 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 1 site 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 29 May 2015). 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) at 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 NCT01924949.

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.