Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (ESRD)
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| ClinicalTrials.gov Identifier: NCT03036839 |
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Recruitment Status :
Completed
First Posted : January 30, 2017
Results First Posted : December 9, 2019
Last Update Posted : March 2, 2020
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Virus Infection | Drug: LDV/SOF | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 95 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 27, 2017 |
| Actual Primary Completion Date : | November 22, 2018 |
| Actual Study Completion Date : | February 14, 2019 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sofosbuvir
| Arm | Intervention/treatment |
|---|---|
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Experimental: LDV/SOF for 8 weeks
Treatment-naive participants with genotype 1 without cirrhosis will receive LDV/SOF for 8 weeks
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Drug: LDV/SOF
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Other Names:
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Experimental: LDV/SOF for 12 weeks
Treatment-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
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Drug: LDV/SOF
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Other Names:
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Experimental: LDV/SOF for 24 weeks
Participants with compensated cirrhosis will receive LDV/SOF for 24 weeks
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Drug: LDV/SOF
90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Other Names:
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Primary Outcome Measures :
- 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.
- Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event [ Time Frame: First dose date up to Week 24 ]
Secondary Outcome Measures :
- 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.
- 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.
- 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.
- HCV RNA [ Time Frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24 ]
- Change From Baseline in HCV RNA [ Time Frame: Weeks 2, 4, 6, 8, 12, 16, 20, 24 ]
- Percentage of Participants With Virologic Failure [ Time Frame: Baseline up to Posttreatment Week 24 ]
Virologic failure was defined as:
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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)
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Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
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- Percentage of Participants Who Developed Resistance to LDV and SOF [ Time Frame: Baseline up to Posttreatment Week 24 ]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036839
Locations
Show 21 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Study Documents (Full-Text)
Documents provided by Gilead Sciences:
Documents provided by Gilead Sciences:
Study Protocol [PDF] March 2, 2017
Statistical Analysis Plan [PDF] November 6, 2018
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT03036839 |
| Other Study ID Numbers: |
GS-US-337-4063 2016-003489-25 ( EudraCT Number ) |
| First Posted: | January 30, 2017 Key Record Dates |
| Results First Posted: | December 9, 2019 |
| Last Update Posted: | March 2, 2020 |
| Last Verified: | November 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | 18 months after study completion |
| Access Criteria: | A secured external environment with username, password, and RSA code. |
| URL: | https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
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Infections Communicable Diseases Hepatitis A Hepatitis C Hepatitis Kidney Failure, Chronic Disease Attributes Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Flaviviridae Infections Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Sofosbuvir Ledipasvir, sofosbuvir drug combination Ledipasvir Antiviral Agents Anti-Infective Agents |