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Hepatitis C Virus InfectionPhase 2ESRDNCT03036839

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

A Phase 2 study testing LDV/SOF in people with Hepatitis C Virus Infection, run by Gilead Sciences at 21 sites in 5 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 safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD. 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
95 participants
Where
21 sitesin 5 countries
Study dates
27 Jun 2017to 14 Feb 2019
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 genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Who cannot join

None listed.

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Texas Liver Institute/American Research Corporation

    San Antonio, Texas, 78215

  • University of Washington/Harborview Medical Center

    Seattle, Washington, 98104

  • James J. Peters VA Hospital

    The Bronx, New York, 10468

Other trials in United States

Taiwan5 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Germany4 sites

  • Klinikum der Johann Wolfgang Goethe-Universität

    Frankfurt, 60590

  • Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol.

    Hamburg, 20246

  • Ifi Studien und Projekt GmbH an der Asklepios Klinik St. Georg

    Hamburg, 20251

  • Universitätsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

Italy4 sites

  • Ospedale Santa Maria Annunziata

    Antella, 50011

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale Casa Sollievo Della Sofferrenza

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Belgium2 sites

  • CUB Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires UCL Saint-Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease

The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.

Being tested
LDV/SOF
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

    90/400 mg fixed- dose combination (FDC) tablet administered orally once daily

Study groups in NCT03036839
Study groupRoleWhat they receive
LDV/SOF for 8 weeksExperimentalTreatment-naive participants with genotype 1 without cirrhosis will receive LDV/SOF for 8 weeks
Receives: Drug: LDV/SOF
LDV/SOF for 12 weeksExperimentalTreatment-experienced participants with genotype 1 and treatment-naive or treatment-experienced participants with genotype 2 (Taiwan only), 4, 5 and 6 without cirrhosis will receive LDV/SOF for 12 weeks
Receives: Drug: LDV/SOF
LDV/SOF for 24 weeksExperimentalParticipants with compensated cirrhosis will receive LDV/SOF for 24 weeks
Receives: Drug: LDV/SOF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

    Measured: First dose date up to Week 24

Secondary outcomes (13)

  1. Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

    SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

    Measured: Posttreatment Week 4

  2. Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

    SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

    Measured: Posttreatment Week 24

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment

    The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA "< LLOQ detected" plus the number of participants with HCV RNA "< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.

    Measured: Weeks 2, 4, 6, 8, 12, 16, 20, 24

  4. HCV RNA

    Measured: Weeks 2, 4, 6, 8, 12, 16, 20, 24

  5. Change From Baseline in HCV RNA

    Measured: Weeks 2, 4, 6, 8, 12, 16, 20, 24

  6. 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 up to Posttreatment Week 24

  7. Percentage of Participants Who Developed Resistance to LDV and SOF

    Measured: Baseline up to Posttreatment Week 24

  8. Pharmacokinetics (PK) Parameter: AUCtau of LDV

    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 Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

  9. 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 Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

  10. 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 Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

  11. PK Parameter: Cmax of LDV

    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 Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

  12. 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 Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

  13. 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 Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))

Timeline

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

  1. First posted30 Jan 2017 (estimated)
  2. Study start27 Jun 2017
  3. Primary completion22 Nov 2018
  4. Study completion14 Feb 2019

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03036839
Sponsor's protocol ID
GS-US-337-4063
Other IDs
2016-003489-25, 2016
Acronym
ESRD
Status last verified
Nov 2019
First submitted
27 Jan 2017
Last updated
2 Mar 2020
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

  • Chuang WL, Hu TH, Buggisch P, Moreno C, Su WW, Biancone L, Camargo M, Hyland R, Lu S, Kirby BJ, Dvory-Sobol H, Osinusi A, Gaggar A, Peng CY, Liu CH, Sise ME, Mangia A. Ledipasvir/Sofosbuvir for 8, 12, or 24 Weeks in Hepatitis C Patients Undergoing Dialysis for End-Stage Renal Disease. Am J Gastroenterol. 2021 Sep 1;116(9):1924-1928. doi: 10.14309/ajg.0000000000001281.

    PubMed 34465694

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 21 sites in 5 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 2 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 21 sites in United States, Taiwan, Germany, Italy, Belgium. 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 9 Dec 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 (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 NCT03036839, 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 2 Mar 2020.

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