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Completed

NCT Number: NCT03036839

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (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.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CUB Hopital Erasme, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Treatment and study plan

LDV/SOF

Drug

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

Other names: Harvoni®, GS-5885/GS-7977

Primary outcomes

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

    Time frame: Posttreatment Week 12

    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.

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

    Time frame: First dose date up to Week 24

Secondary outcomes

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

    Time frame: Posttreatment Week 4

    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.

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

    Time frame: Posttreatment Week 24

    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.

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

    Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24

    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.

  4. HCV RNA

    Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24

  5. Change From Baseline in HCV RNA

    Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24

  6. Percentage of Participants With Virologic Failure

    Time frame: Baseline up to Posttreatment Week 24

    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.

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

    Time frame: Baseline up to Posttreatment Week 24

  8. Pharmacokinetics (PK) Parameter: AUCtau of LDV

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

    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

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

    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

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

    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.

  11. PK Parameter: Cmax of LDV

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

    Cmax is defined as the population PK derived maximum concentration of the drug.

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

    Cmax is defined as the population PK derived maximum concentration of the drug.

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

    Cmax is defined as the population PK derived maximum concentration of the drug.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Acronym: ESRD

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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