Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
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|ClinicalTrials.gov Identifier: NCT01924949|
Recruitment Status : Completed
First Posted : August 19, 2013
Results First Posted : May 29, 2015
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: LDV/SOF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||August 2014|
Participants will receive LDV/SOF FDC for 12 weeks.
Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily
- 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 ]
- 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 ]SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
- 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 ]
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)
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
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): NCT01924949
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Study Director:||Luisa Stamm, MD, PhD||Gilead Sciences|