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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
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
Intervention Drug: LDV/SOF
Enrollment 5
Recruitment Details Participants were enrolled at 1 study site in the United States. The first participant was screened on 29 July 2013. The last study visit occurred on 18 August 2014.
Pre-assignment Details 8 participants were screened.
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
62  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 5 participants
5
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 5 participants
5
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
CC 1
CT 3
TT 1
[1]
Measure Description: 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 5 participants
5.9  (0.58)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
< 800,000 IU/mL 3
≥ 800,000 IU/mL 2
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 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: participants who were enrolled and received at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
100.0
2.Primary Outcome
Title Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 100.0
SVR24 100.0
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ on Treatment
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 60.0
Week 4 100.0
Week 8 100.0
Week 12 100.0
5.Secondary Outcome
Title HCV RNA Change From Baseline
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 -4.36  (0.463)
Change at Week 4 -4.56  (0.576)
Change at Week 8 -4.56  (0.576)
6.Secondary Outcome
Title Percentage of Participants Experiencing 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
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 12 Weeks
Hide Arm/Group Description LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
All-Cause Mortality
LDV/SOF 12 Weeks
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF 12 Weeks
Affected / at Risk (%)
Total   1/5 (20.00%) 
Cardiac disorders   
Acute myocardial infarction  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 17
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 12 Weeks
Affected / at Risk (%)
Total   4/5 (80.00%) 
Gastrointestinal disorders   
Diarrhoea  1  1/5 (20.00%) 
Flatulence  1  1/5 (20.00%) 
Nausea  1  1/5 (20.00%) 
General disorders   
Influenza like illness  1  1/5 (20.00%) 
Pain  1  1/5 (20.00%) 
Injury, poisoning and procedural complications   
Contusion  1  1/5 (20.00%) 
Investigations   
Weight increased  1  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders   
Neck pain  1  1/5 (20.00%) 
Nervous system disorders   
Dysgeusia  1  1/5 (20.00%) 
Headache  1  1/5 (20.00%) 
Skin and subcutaneous tissue disorders   
Petechiae  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 17
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: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01924949     History of Changes
Other Study ID Numbers: GS-US-337-0125
First Submitted: August 14, 2013
First Posted: August 19, 2013
Results First Submitted: May 13, 2015
Results First Posted: May 29, 2015
Last Update Posted: November 19, 2018