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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03036839
Other study ID # GS-US-337-4063
Secondary ID 2016-003489-25
Status Completed
Phase Phase 2
First received
Last updated
Start date June 27, 2017
Est. completion date February 14, 2019

Study information

Verified date November 2019
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date February 14, 2019
Est. primary completion date November 22, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Belgium Cliniques Universitaires UCL Saint-Luc Brussels
Belgium CUB Hopital Erasme Brussels
Germany Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Germany Ifi Studien und Projekt GmbH an der Asklepios Klinik St. Georg Hamburg
Germany Universitatsklinikum Hamburg-Eppendorf (UKE), Zentrum fur Innere Medizin - Studienambulanz Hepatol. Hamburg
Germany Universitätsklinikum Leipzig Leipzig
Italy Ospedale Santa Maria Annunziata Antella
Italy Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan
Italy IRCCS Ospedale Casa Sollievo Della Sofferrenza San Giovanni Rotondo Foggia
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino
Taiwan Changhua Christian Hospital Changhua
Taiwan Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
United States Massachusetts General Hospital Boston Massachusetts
United States James J. Peters VA Hospital Bronx New York
United States The Liver Institute at Methodist Dallas Medical Center Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States Texas Liver Institute/American Research Corporation San Antonio Texas
United States University of Washington/Harborview Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Taiwan, 

References & Publications (1)

Chuang W-L, Hu T-H, Buggisch P, et al. Ledipasvir/sofosbuvir for 8, 12, or 24 weeks is safe and effective in patients undergoing dialysis. J Hepatol 2019;70 (Suppl 1S):e225.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Posttreatment Week 12
Primary Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event First dose date up to Week 24
Secondary 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. Posttreatment Week 4
Secondary 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. Posttreatment Week 24
Secondary 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. Weeks 2, 4, 6, 8, 12, 16, 20, 24
Secondary HCV RNA Weeks 2, 4, 6, 8, 12, 16, 20, 24
Secondary Change From Baseline in HCV RNA Weeks 2, 4, 6, 8, 12, 16, 20, 24
Secondary 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.
Baseline up to Posttreatment Week 24
Secondary Percentage of Participants Who Developed Resistance to LDV and SOF Baseline up to Posttreatment Week 24
Secondary 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. 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))
Secondary 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. 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))
Secondary 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. 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))
Secondary PK Parameter: Cmax of LDV Cmax is defined as the population PK derived maximum concentration of the drug. 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))
Secondary PK Parameter: Cmax of SOF Cmax is defined as the population PK derived maximum concentration of the drug. 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))
Secondary PK Parameter: Cmax of GS-331007 (Metabolite of SOF) Cmax is defined as the population PK derived maximum concentration of the drug. 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))
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