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Trial record 1 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"
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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
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: LDV/SOF
Enrollment 19
Recruitment Details Participants were enrolled at one study site in Egypt. The first participant was screened on 28 August 2016. The last study visit occurred on 03 February 2019.
Pre-assignment Details 24 participants were screened.
Arm/Group Title LDV/SOF
Hide Arm/Group Description LDV/SOF 90/400 mg fixed dose combination (FDC) orally once daily for 12 weeks
Period Title: Overall Study
Started 19
Completed 19
Not Completed 0
Arm/Group Title LDV/SOF
Hide Arm/Group Description LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
Safety Analysis Set included participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
14  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
3
  15.8%
Male
16
  84.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
19
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 19 participants
19
 100.0%
IL28B   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
CC
6
  31.6%
CT
12
  63.2%
TT
1
   5.3%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 19 participants
5.3  (1.65)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
< 800,000 IU/mL
12
  63.2%
≥ 800,000 IU/mL
7
  36.8%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included participants who took at least 1 dose of study drug.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(82.4 to 100.0)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame First dose date up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included participants who took at least 1 dose of study drug.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC once daily for 12 weeks
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(82.4 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)
Hide Description SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(82.4 to 100.0)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ While on Treatment
Hide Description [Not Specified]
Time Frame Weeks 1, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF FDC 90/400 mg orally once daily for 12 weeks
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
89.5
(66.9 to 98.7)
Week 4
100.0
(82.4 to 100.0)
Week 8
94.7
(74.0 to 99.9)
Week 12
100.0
(82.4 to 100.0)
6.Secondary Outcome
Title HCV RNA Change From Baseline/Day 1
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 -3.34  (1.730)
Change at Week 4 -3.62  (1.653)
Change at Week 8 -3.36  (1.526)
Change at Week 12 -3.62  (1.653)
7.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

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
Time Frame Baseline to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
Adverse Event Reporting Description Safety Analysis Set included participants who took at least 1 dose of study drug.
 
Arm/Group Title LDV/SOF
Hide Arm/Group Description LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
All-Cause Mortality
LDV/SOF
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF
Affected / at Risk (%)
Total   3/19 (15.79%) 
Gastrointestinal disorders   
Diarrhoea  1  1/19 (5.26%) 
Infections and infestations   
Pneumonia  1  2/19 (10.53%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  1/19 (5.26%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF
Affected / at Risk (%)
Total   15/19 (78.95%) 
Blood and lymphatic system disorders   
Anaemia  1  2/19 (10.53%) 
Gastrointestinal disorders   
Abdominal pain  1  1/19 (5.26%) 
Diarrhoea  1  3/19 (15.79%) 
Lip ulceration  1  1/19 (5.26%) 
Mouth ulceration  1  1/19 (5.26%) 
Tongue ulceration  1  1/19 (5.26%) 
Vomiting  1  3/19 (15.79%) 
General disorders   
Pyrexia  1  5/19 (26.32%) 
Infections and infestations   
Conjunctivitis  1  1/19 (5.26%) 
Ear infection  1  1/19 (5.26%) 
Oral candidiasis  1  1/19 (5.26%) 
Pneumonia  1  1/19 (5.26%) 
Investigations   
Neutrophil count decreased  1  2/19 (10.53%) 
Metabolism and nutrition disorders   
Hypophagia  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Joint effusion  1  1/19 (5.26%) 
Osteonecrosis  1  1/19 (5.26%) 
Nervous system disorders   
Headache  1  4/19 (21.05%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/19 (10.53%) 
Productive cough  1  1/19 (5.26%) 
Rhinorrhoea  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Pruritus generalised  1  1/19 (5.26%) 
Skin lesion  1  1/19 (5.26%) 
Skin ulcer  1  1/19 (5.26%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02868242     History of Changes
Other Study ID Numbers: GS-US-337-1904
First Submitted: August 11, 2016
First Posted: August 16, 2016
Results First Submitted: July 29, 2019
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019