Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02868242|
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C Virus Infection||Drug: LDV/SOF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Undergoing Cancer Chemotherapy|
|Actual Study Start Date :||August 28, 2016|
|Actual Primary Completion Date :||November 12, 2018|
|Actual Study Completion Date :||February 3, 2019|
Participants will receive LDV/SOF 90/400 mg fixed dose combination (FDC) (1x 90/400 mg tablet or 4 x 22.5/100 mg tablets based on swallowability assessment during screening) for 12 weeks.
Tablet(s) administered orally once daily
- Percentage of Participants With Sustained Virologic Response (SVR) 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, 50 IU/mL) at 12 weeks after stopping study treatment.
- Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event [ Time Frame: First dose date up to Week 12 ]
- Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4) [ Time Frame: Posttreatment Week 4 ]SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
- Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) [ Time Frame: Posttreatment Week 24 ]SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
- Percentage of Participants With HCV RNA < LLOQ While on Treatment [ Time Frame: Weeks 1, 4, 8, and 12 ]
- HCV RNA Change From Baseline/Day 1 [ Time Frame: Baseline; Weeks 1, 4, 8, and 12 ]
- Percentage of Participants With 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): NCT02868242
|National Cancer Institute, Cairo University|
|Study Director:||Gilead Study Director||Gilead Sciences|