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Trial record 34 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

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ClinicalTrials.gov Identifier: NCT02120300
Recruitment Status : Completed
First Posted : April 22, 2014
Results First Posted : December 6, 2016
Last Update Posted : December 6, 2016
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 Chronic HCV Infection
Interventions Drug: LDV/SOF
Drug: SOF
Drug: RBV
Enrollment 122
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 10 April 2014. The last study visit occurred on 17 August 2015.
Pre-assignment Details 147 participants were screened.
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4) LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis) Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2) SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Period Title: Overall Study
Started 101 5 10 6
Completed 98 5 10 5
Not Completed 3 0 0 1
Reason Not Completed
Enrolled but Never Treated             2             0             0             0
Lack of Efficacy             0             0             0             1
Lost to Follow-up             1             0             0             0
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3 Total
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4) LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis) Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2) SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3) Total of all reporting groups
Overall Number of Baseline Participants 99 5 10 6 120
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
44  (11.1) 49  (11.1) 48  (13.8) 47  (6.7) 45  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
Female
6
   6.1%
0
   0.0%
1
  10.0%
0
   0.0%
7
   5.8%
Male
93
  93.9%
5
 100.0%
9
  90.0%
6
 100.0%
113
  94.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
Hispanic or Latino
4
   4.0%
0
   0.0%
1
  10.0%
0
   0.0%
5
   4.2%
Not Hispanic or Latino
95
  96.0%
5
 100.0%
9
  90.0%
6
 100.0%
115
  95.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
Black or African American 18 1 1 0 20
White 75 4 8 5 92
Asian 4 0 1 1 6
Other 2 0 0 0 2
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
No 71 0 8 4 83
Yes 28 5 2 2 37
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
Genotype 1 98 5 0 0 103
Genotype 2 0 0 10 0 10
Genotype 3 0 0 0 6 6
Genotype 4 1 0 0 0 1
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
6.2  (0.67) 6.0  (0.85) 6.2  (1.00) 6.6  (0.80) 6.2  (0.71)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
< 800,000 IU/mL 23 2 2 1 28
≥ 800,000 IU/mL 76 3 8 5 92
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
CC 22 2 7 5 36
CT 60 1 3 1 65
TT 17 2 0 0 19
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
HIV Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 5 participants 10 participants 6 participants 120 participants
Negative 80 5 6 3 94
Positive 19 0 4 3 26
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: participants enrolled into the study and received at least 1 dose of study drug.
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 99 5 10 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.0
(94.5 to 100.0)
100.0
(47.8 to 100.0)
100.0
(69.2 to 100.0)
83.3
(35.9 to 99.6)
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 GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 99 5 10 6
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0
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 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 99 5 10 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.0
(94.5 to 100.0)
100.0
(47.8 to 100.0)
100.0
(69.2 to 100.0)
83.3
(35.9 to 99.6)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, 12, 16, 20, and 24
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 GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 99 5 10 6
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 28.3 20.0 20.0 16.7
Week 2 68.7 40.0 70.0 33.3
Week 4 94.9 100.0 100.0 66.7
Week 8 100.0 100.0 100.0 100.0
Week 12 99.0 100.0 100.0 100.0
Week 16 NA [1]  100.0 NA [1]  100.0
Week 20 NA [1]  100.0 NA [1]  100.0
Week 24 NA [1]  100.0 NA [1]  100.0
[1]
Treatment for this group was only 12 weeks.
5.Secondary Outcome
Title Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24
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 GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 99 5 10 6
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Baseline 6.21  (0.673) 6.02  (0.847) 6.20  (1.002) 6.6  (0.803)
Week 1 (LDV/SOF 12 Weeks: n= 98) -4.41  (0.580) -4.32  (0.815) -4.39  (0.633) -3.95  (0.473)
Week 2 (LDV/SOF 24 Week: n=4) -4.87  (0.642) -4.65  (0.967) -5.01  (0.965) -4.76  (0.797)
Week 4 -5.05  (0.662) -4.87  (0.847) -5.05  (1.002) -5.26  (0.786)
Week 8 -5.06  (0.673) -4.87  (0.847) -5.05  (1.002) -5.45  (0.803)
Week 12 (LDV/SOF 12 Weeks: n= 98) -5.06  (0.675) -4.87  (0.847) -5.05  (1.002) -5.45  (0.803)
Week 16 NA [1]   (NA) -4.87  (0.847) NA [1]   (NA) -5.45  (0.803)
Week 20 NA [1]   (NA) -4.87  (0.847) NA [1]   (NA) -5.45  (0.803)
Week 24 NA [1]   (NA) -4.87  (0.847) NA [1]   (NA) -5.45  (0.803)
[1]
Treatment for this group was only 12 weeks.
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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 99 5 10 6
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 16.7
7.Secondary Outcome
Title Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)
Hide Description [Not Specified]
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 19 4 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 100 100 100
Week 8 100 100 100
Week 12 100 100 100
Week 16 NA [1]  NA [1]  100
Week 20 NA [1]  NA [1]  100
Week 24 NA [1]  NA [1]  66.7
[1]
Treatment for this group was only 12 weeks.
8.Secondary Outcome
Title Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)
Hide Description [Not Specified]
Time Frame Baseline; Weeks 12, 24, and Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
Overall Number of Participants Analyzed 19 4 3
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 0.94  (0.197) 1.01  (0.118) 0.94  (0.086)
Week 12 0.04  (0.079) -0.03  (0.095) -0.03  (0.093)
Week 24 NA [1]   (NA) NA [1]   (NA) -0.08  (0.069)
Posttreatment Week12 -0.01  (0.113) -0.08  (0.015) -0.02  (0.081)
[1]
Treatment for this group was only 12 weeks.
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4) LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis) Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2) SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
All-Cause Mortality
LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF 12 Weeks GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/99 (5.05%)   0/5 (0.00%)   0/10 (0.00%)   1/6 (16.67%) 
Gastrointestinal disorders         
Gastrointestinal haemorrhage  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders         
Cholecystitis acute  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders         
Haemarthrosis  1  2/99 (2.02%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Psychiatric disorders         
Suicidal ideation  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Social circumstances         
Miscarriage of partner  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Vascular disorders         
Haematoma  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0.
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 GT1 or GT4 LDV/SOF 24 Weeks GT1 (TE) SOF+RBV 12 Weeks GT2 SOF+RBV 24 Weeks GT3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/99 (54.55%)   3/5 (60.00%)   8/10 (80.00%)   4/6 (66.67%) 
Blood and lymphatic system disorders         
Anaemia  1  0/99 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Gastrointestinal disorders         
Constipation  1  1/99 (1.01%)  2/5 (40.00%)  0/10 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  7/99 (7.07%)  0/5 (0.00%)  1/10 (10.00%)  3/6 (50.00%) 
Dry mouth  1  2/99 (2.02%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Food poisoning  1  0/99 (0.00%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Nausea  1  8/99 (8.08%)  0/5 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Toothache  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Vomiting  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
General disorders         
Chills  1  0/99 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Fatigue  1  29/99 (29.29%)  1/5 (20.00%)  3/10 (30.00%)  2/6 (33.33%) 
Influenza like illness  1  1/99 (1.01%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/99 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Infections and infestations         
Bronchitis  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Folliculitis  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Influenza  1  1/99 (1.01%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications         
Muscle strain  1  1/99 (1.01%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  2/99 (2.02%)  0/5 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Hypoglycaemia  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  3/99 (3.03%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Haemarthrosis  1  8/99 (8.08%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Muscle haemorrhage  1  5/99 (5.05%)  0/5 (0.00%)  0/10 (0.00%)  0/6 (0.00%) 
Myalgia  1  3/99 (3.03%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Osteorrhagia  1  0/99 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Nervous system disorders         
Disturbance in attention  1  6/99 (6.06%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Headache  1  14/99 (14.14%)  0/5 (0.00%)  3/10 (30.00%)  0/6 (0.00%) 
Psychiatric disorders         
Anxiety  1  5/99 (5.05%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Insomnia  1  6/99 (6.06%)  0/5 (0.00%)  1/10 (10.00%)  3/6 (50.00%) 
Irritability  1  2/99 (2.02%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Mood altered  1  0/99 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/99 (1.01%)  0/5 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Epistaxis  1  2/99 (2.02%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Oropharyngeal pain  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Rhinorrhoea  1  0/99 (0.00%)  0/5 (0.00%)  0/10 (0.00%)  1/6 (16.67%) 
Sinus congestion  1  0/99 (0.00%)  0/5 (0.00%)  1/10 (10.00%)  2/6 (33.33%) 
Skin and subcutaneous tissue disorders         
Pruritus  1  1/99 (1.01%)  0/5 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Rash  1  1/99 (1.01%)  0/5 (0.00%)  1/10 (10.00%)  1/6 (16.67%) 
Vascular disorders         
Haemorrhage  1  0/99 (0.00%)  1/5 (20.00%)  0/10 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0.
There were no limitations affecting the analysis or results.
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:
Walsh C, Workowski K, Terrault N, Sax S, Cohen A, et al. Approved All-Oral Sofosbuvir Regimens Are Safe and Highly Effective in Patients With Hereditary Bleeding Disorders. (2015). Hepatology, 62 (S1): 714A-807A. doi:10.1002/hep.28228
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02120300     History of Changes
Other Study ID Numbers: GS-US-334-1274
First Submitted: April 18, 2014
First Posted: April 22, 2014
Results First Submitted: August 16, 2016
Results First Posted: December 6, 2016
Last Update Posted: December 6, 2016