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Trial record 12 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02301936
Recruitment Status : Completed
First Posted : November 26, 2014
Results First Posted : May 25, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: LDV/SOF
Enrollment 10
Recruitment Details Participants were enrolled at 1 study site in the United States. The first participant was screened on 02 March 2015. The last study visit occurred on 18 April 2016.
Pre-assignment Details  
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Period Title: Overall Study
Started 9 1
Completed 8 1
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks Total
Hide Arm/Group Description Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 9 1 10
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 1 participants 10 participants
43  (14.9) 44 [1]   (NA) 43  (14.1)
[1]
This treatment group had 1 participant only so standard deviation (SD) is not applicable.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 1 participants 10 participants
Female
3
  33.3%
1
 100.0%
4
  40.0%
Male
6
  66.7%
0
   0.0%
6
  60.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Black or African American Number Analyzed 9 participants 1 participants 10 participants
9
 100.0%
1
 100.0%
10
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 9 participants 1 participants 10 participants
9
 100.0%
1
 100.0%
10
 100.0%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 1 participants 10 participants
CC
1
  11.1%
0
   0.0%
1
  10.0%
CT
2
  22.2%
1
 100.0%
3
  30.0%
TT
6
  66.7%
0
   0.0%
6
  60.0%
[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 9 participants 1 participants 10 participants
5.8  (0.74) 6.2 [1]   (NA) 5.8  (0.71)
[1]
This treatment group had 1 participant only so SD is not applicable.
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 1 participants 10 participants
< 800,000 IU/mL
6
  66.7%
0
   0.0%
6
  60.0%
≥ 800,000 IU/mL
3
  33.3%
1
 100.0%
4
  40.0%
HCV genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 1 participants 10 participants
Genotype 1a
5
  55.6%
1
 100.0%
6
  60.0%
Genotype 1b
1
  11.1%
0
   0.0%
1
  10.0%
Genotype 4a/4c/4d
1
  11.1%
0
   0.0%
1
  10.0%
Genotype 4f
1
  11.1%
0
   0.0%
1
  10.0%
Genotype 4h
1
  11.1%
0
   0.0%
1
  10.0%
Cirrhosis status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 1 participants 10 participants
Absence
9
 100.0%
0
   0.0%
9
  90.0%
Presence
0
   0.0%
1
 100.0%
1
  10.0%
Prior HCV Treatment Experience With Cirrhosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 1 participants 10 participants
Treatment-Naive (Non-cirrhosis)
7
  77.8%
0
   0.0%
7
  70.0%
Treatment-Experienced (Non-cirrhosis)
2
  22.2%
0
   0.0%
2
  20.0%
Treatment-Experienced (Cirrhosis)
0
   0.0%
1
 100.0%
1
  10.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who took at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Measure Type: Number
Unit of Measure: percentage of participants
88.9 100.0
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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Measure Type: Number
Unit of Measure: percentage of participants
0 0
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Measure Type: Number
Unit of Measure: percentage of participants
88.9 100.0
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ on Treatment
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8,12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 Number Analyzed 9 participants 1 participants
33.3 0
Week 2 Number Analyzed 9 participants 1 participants
66.7 0
Week 4 Number Analyzed 9 participants 1 participants
88.9 100.0
Week 8 Number Analyzed 9 participants 1 participants
88.9 100.0
Week 12 Number Analyzed 9 participants 1 participants
100.0 100.0
Week 16 Number Analyzed 0 participants 1 participants
100
Week 20 Number Analyzed 0 participants 1 participants
100
Week 24 Number Analyzed 0 participants 1 participants
100
5.Secondary Outcome
Title HCV RNA Change From Baseline
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 6 participants 1 participants
-4.20  (0.543) -3.86 [1]   (NA)
Change at Week 2 Number Analyzed 9 participants 1 participants
-3.86  (1.644) -4.63 [1]   (NA)
Change at Week 4 Number Analyzed 9 participants 1 participants
-3.98  (1.694) -5.05 [1]   (NA)
Change at Week 8 Number Analyzed 9 participants 1 participants
-4.47  (0.662) -5.05 [1]   (NA)
Change at Week 12 Number Analyzed 9 participants 1 participants
-4.61  (0.737) -5.05 [1]   (NA)
Change at Week 16 Number Analyzed 0 participants 1 participants
-5.05 [1]   (NA)
Change at Week 20 Number Analyzed 0 participants 1 participants
-5.05 [1]   (NA)
Change at Week 24 Number Analyzed 0 participants 1 participants
-5.05 [1]   (NA)
[1]
This group had only 1 participant so SD is not applicable.
6.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as

  • On-treatment virologic failure

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
  • Relapse

    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Time Frame Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Measure Type: Number
Unit of Measure: percentage of participants
11.1 0
7.Secondary Outcome
Title Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score
Hide Description The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.
Time Frame Weeks 4,12, 24, Posttreatment Weeks 4 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 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 9 participants 1 participants
1.2  (6.66) 8.5 [1]   (NA)
Week 12 Number Analyzed 9 participants 1 participants
2.7  (7.20) 5.8 [1]   (NA)
Week 24 Number Analyzed 0 participants 1 participants
2.3 [1]   (NA)
Posttreatment Week 4 Number Analyzed 8 participants 1 participants
3.5  (8.26) 0.1 [1]   (NA)
Posttreatment Week 12 Number Analyzed 8 participants 1 participants
0.7  (12.46) 5.5 [1]   (NA)
[1]
This group had only 1 participant so SD is not applicable.
8.Secondary Outcome
Title Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score
Hide Description The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.
Time Frame Weeks 4,12, 24, Posttreatment Weeks 4 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 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 9 participants 1 participants
2.2  (8.88) -4.7 [1]   (NA)
Week 12 Number Analyzed 9 participants 1 participants
3.2  (8.14) -3.3 [1]   (NA)
Week 24 Number Analyzed 0 participants 1 participants
-3.9 [1]   (NA)
Posttreatment Week 4 Number Analyzed 8 participants 1 participants
2.2  (9.69) -4.6 [1]   (NA)
Posttreatment Week 12 Number Analyzed 8 participants 1 participants
2.4  (6.53) -5.0 [1]   (NA)
[1]
This group had only 1 participant so SD is not applicable.
9.Secondary Outcome
Title Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Hide Description The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.
Time Frame Weeks 4,12, 24, Posttreatment Weeks 4 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 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
Overall Number of Participants Analyzed 9 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 8 participants 1 participants
4.6  (13.86) -0.2 [1]   (NA)
Week 12 Number Analyzed 8 participants 1 participants
9.8  (17.15) 14.5 [1]   (NA)
Week 24 Number Analyzed 0 participants 1 participants
11.7 [1]   (NA)
Posttreatment Week 4 Number Analyzed 7 participants 1 participants
13.0  (17.20) 13.2 [1]   (NA)
Posttreatment Week 24 Number Analyzed 7 participants 1 participants
8.5  (6.32) 5.0 [1]   (NA)
[1]
This group had only 1 participant so SD is not applicable.
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks. Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
All-Cause Mortality
LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   0/1 (0.00%) 
Blood and lymphatic system disorders     
Sickle cell anaemia with crisis  1  1/9 (11.11%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
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 12 Weeks LDV/SOF 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   6/9 (66.67%)   1/1 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/9 (11.11%)  0/1 (0.00%) 
Sickle cell anaemia with crisis  1  1/9 (11.11%)  0/1 (0.00%) 
Eye disorders     
Eye discharge  1  0/9 (0.00%)  1/1 (100.00%) 
Gastrointestinal disorders     
Nausea  1  2/9 (22.22%)  0/1 (0.00%) 
General disorders     
Fatigue  1  1/9 (11.11%)  1/1 (100.00%) 
Pyrexia  1  1/9 (11.11%)  0/1 (0.00%) 
Infections and infestations     
Atypical pneumonia  1  1/9 (11.11%)  0/1 (0.00%) 
Pneumonia  1  0/9 (0.00%)  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/9 (11.11%)  0/1 (0.00%) 
Flank pain  1  1/9 (11.11%)  0/1 (0.00%) 
Musculoskeletal chest pain  1  0/9 (0.00%)  1/1 (100.00%) 
Nervous system disorders     
Headache  1  6/9 (66.67%)  0/1 (0.00%) 
Psychiatric disorders     
Insomnia  1  0/9 (0.00%)  1/1 (100.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/9 (11.11%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
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: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02301936     History of Changes
Other Study ID Numbers: GS-US-337-1405
First Submitted: November 24, 2014
First Posted: November 26, 2014
Results First Submitted: April 18, 2017
Results First Posted: May 25, 2017
Last Update Posted: November 19, 2018