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Trial record 15 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection

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ClinicalTrials.gov Identifier: NCT02413593
Recruitment Status : Completed
First Posted : April 10, 2015
Results First Posted : February 14, 2017
Last Update Posted : November 16, 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 Virus Infection
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 111
Recruitment Details Participants were enrolled at study sites in Canada. The first participant was screened on 15 April 2015. The last study visit occurred on 08 January 2016.
Pre-assignment Details 127 participants were screened.
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Period Title: Overall Study
Started 111
Completed 107
Not Completed 4
Reason Not Completed
Lost to Follow-up             3
Adverse Event             1
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants
48  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
43
  38.7%
Male
68
  61.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
111
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
American Indian or Alaska Native
3
   2.7%
Asian
28
  25.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   0.9%
White
78
  70.3%
More than one race
1
   0.9%
Unknown or Not Reported
0
   0.0%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Genotype 3 (no confirmed subtype)
3
   2.7%
Genotype 3a
105
  94.6%
Genotype 3b
3
   2.7%
Cirrhosis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Absent
70
  63.1%
Present
39
  35.1%
Missing
2
   1.8%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
CC
40
  36.0%
CT
56
  50.5%
TT
13
  11.7%
Missing
2
   1.8%
[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 111 participants
6.2  (0.66)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
< 800,000 IU/mL
35
  31.5%
≥ 800,000 IU/mL
76
  68.5%
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, 15 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: all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
89.2
(81.9 to 94.3)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any 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
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: percentage of participants
0.9
3.Secondary Outcome
Title Percentage of Participants With SVR 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
Full Analysis Set
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.9
(85.2 to 96.2)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 Number Analyzed 111 participants
20.7
(13.6 to 29.5)
Week 2 Number Analyzed 111 participants
64.9
(55.2 to 73.7)
Week 4 Number Analyzed 111 participants
97.3
(92.3 to 99.4)
Week 8 Number Analyzed 111 participants
100.0
(96.7 to 100.0)
Week 12 Number Analyzed 110 participants
99.1
(95.0 to 100.0)
5.Secondary Outcome
Title Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 110 participants
-4.33  (0.572)
Change at Week 2 Number Analyzed 111 participants
-4.85  (0.659)
Change at Week 4 Number Analyzed 111 participants
-5.05  (0.664)
Change at Week 8 Number Analyzed 111 participants
-5.06  (0.664)
Change at Week 12 Number Analyzed 109 participants
-5.06  (0.669)
6.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 Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: percentage of participants
7.2
Time Frame Baseline to 30 days after last dose of study drug (up to 12 weeks plus 30 days)
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF+RBV
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
All-Cause Mortality
LDV/SOF+RBV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF+RBV
Affected / at Risk (%)
Total   4/111 (3.60%) 
Metabolism and nutrition disorders   
Hyponatraemia  1  1/111 (0.90%) 
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion  1  1/111 (0.90%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic cancer  1  1/111 (0.90%) 
Psychiatric disorders   
Homicidal ideation  1  1/111 (0.90%) 
Suicidal ideation  1  1/111 (0.90%) 
Vascular disorders   
Hypertensive crisis  1  1/111 (0.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF+RBV
Affected / at Risk (%)
Total   89/111 (80.18%) 
Gastrointestinal disorders   
Abdominal pain  1  6/111 (5.41%) 
Diarrhoea  1  11/111 (9.91%) 
Nausea  1  25/111 (22.52%) 
Vomiting  1  7/111 (6.31%) 
General disorders   
Fatigue  1  57/111 (51.35%) 
Infections and infestations   
Nasopharyngitis  1  8/111 (7.21%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  7/111 (6.31%) 
Nervous system disorders   
Dizziness  1  13/111 (11.71%) 
Headache  1  40/111 (36.04%) 
Psychiatric disorders   
Depression  1  6/111 (5.41%) 
Insomnia  1  19/111 (17.12%) 
Irritability  1  11/111 (9.91%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/111 (7.21%) 
Dyspnoea  1  6/111 (5.41%) 
Dyspnoea exertional  1  6/111 (5.41%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  7/111 (6.31%) 
Rash  1  7/111 (6.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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
Publications of Results:
Feld JJ, Ramji A, Shafran S, Willems B, Marotta P, Huchet E, et al. Ledipasvir/Sofosbuvir with ribavirin for 12 Weeks is effective and safe in treatment-naïve genotype 3 HCV-infected patients in Canada [Abstract SAT-183]. Presented at: The 51st Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2016 April 13-17; Barcelona, Spain.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02413593     History of Changes
Other Study ID Numbers: GS-US-337-1701
First Submitted: April 7, 2015
First Posted: April 10, 2015
Results First Submitted: December 22, 2016
Results First Posted: February 14, 2017
Last Update Posted: November 16, 2018