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Trial record 14 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

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ClinicalTrials.gov Identifier: NCT02251717
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : November 17, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: LDV/SOF
Enrollment 114
Recruitment Details Participants were enrolled at study sites in Europe. The first participant was screened on 14 October 2014. The last study visit occurred on 16 June 2016.
Pre-assignment Details 130 participants were screened.
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
Period Title: Overall Study
Started 57 57
Completed 56 56
Not Completed 1 1
Reason Not Completed
Adverse Event             0             1
Withdrew Consent             1             0
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks Total
Hide Arm/Group Description LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant Total of all reporting groups
Overall Number of Baseline Participants 57 57 114
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 57 participants 57 participants 114 participants
54  (8.3) 53  (10.0) 53  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Female
24
  42.1%
24
  42.1%
48
  42.1%
Male
33
  57.9%
33
  57.9%
66
  57.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Hispanic or Latino
1
   1.8%
4
   7.0%
5
   4.4%
Not Hispanic or Latino
56
  98.2%
53
  93.0%
109
  95.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Black or African American
2
   3.5%
2
   3.5%
4
   3.5%
White
54
  94.7%
53
  93.0%
107
  93.9%
Asian
1
   1.8%
1
   1.8%
2
   1.8%
Other
0
   0.0%
1
   1.8%
1
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Austria 9 15 24
Italy 32 17 49
France 15 21 36
Germany 1 4 5
HCV genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Genotype 1
51
  89.5%
53
  93.0%
104
  91.2%
Genotype 4
6
  10.5%
4
   7.0%
10
   8.8%
Cirrhosis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
No
49
  86.0%
48
  84.2%
97
  85.1%
Yes
8
  14.0%
9
  15.8%
17
  14.9%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
CC
14
  24.6%
18
  31.6%
32
  28.1%
CT
34
  59.6%
34
  59.6%
68
  59.6%
TT
9
  15.8%
5
   8.8%
14
  12.3%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
Years From Most Recent Kidney Transplant  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 57 participants 114 participants
12.1  (9.51) 14.4  (9.66) 13.2  (9.61)
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 57 participants 57 participants 114 participants
6.3  (0.63) 6.2  (0.53) 6.3  (0.58)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
< 800,000 IU/mL
11
  19.3%
16
  28.1%
27
  23.7%
≥ 800,000 IU/mL
46
  80.7%
41
  71.9%
87
  76.3%
Prior HCV Treatment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 57 participants 114 participants
Treatment-Naive
40
  70.2%
39
  68.4%
79
  69.3%
Treatment-Experienced
17
  29.8%
18
  31.6%
35
  30.7%
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 who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(93.7 to 100.0)
100.0
(93.7 to 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: participants who received at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of participants
1.8 0
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR24 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: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
100.0
(93.7 to 100.0)
100.0
(93.7 to 100.0)
SVR24
100.0
(93.7 to 100.0)
100.0
(93.7 to 100.0)
4.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: participants who were randomized into the study and received at least 1 dose of study drug
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description:
LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who received at least 1 dose of study drug
 
Arm/Group Title LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Hide Arm/Group Description LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
All-Cause Mortality
LDV/SOF 12 Weeks LDV/SOF 24 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (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   5/57 (8.77%)   8/57 (14.04%) 
Gastrointestinal disorders     
Diarrhoea haemorrhagic  1  0/57 (0.00%)  1/57 (1.75%) 
Infections and infestations     
Erysipelas  1  1/57 (1.75%)  0/57 (0.00%) 
Gastroenteritis  1  1/57 (1.75%)  0/57 (0.00%) 
Urinary tract infection  1  0/57 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications     
Incisional hernia  1  0/57 (0.00%)  1/57 (1.75%) 
Shunt thrombosis  1  0/57 (0.00%)  1/57 (1.75%) 
Investigations     
Blood creatinine increased  1  0/57 (0.00%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/57 (0.00%)  1/57 (1.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Papillary thyroid cancer  1  0/57 (0.00%)  1/57 (1.75%) 
Nervous system disorders     
Syncope  1  1/57 (1.75%)  0/57 (0.00%) 
Psychiatric disorders     
Suicide attempt  1  1/57 (1.75%)  0/57 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/57 (1.75%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/57 (0.00%)  1/57 (1.75%) 
Surgical and medical procedures     
Arteriovenous shunt operation  1  0/57 (0.00%)  1/57 (1.75%) 
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   23/57 (40.35%)   36/57 (63.16%) 
Blood and lymphatic system disorders     
Anaemia  1  1/57 (1.75%)  3/57 (5.26%) 
Gastrointestinal disorders     
Abdominal pain  1  0/57 (0.00%)  4/57 (7.02%) 
Diarrhoea  1  3/57 (5.26%)  5/57 (8.77%) 
Nausea  1  3/57 (5.26%)  3/57 (5.26%) 
Vomiting  1  3/57 (5.26%)  1/57 (1.75%) 
General disorders     
Asthenia  1  8/57 (14.04%)  8/57 (14.04%) 
Fatigue  1  4/57 (7.02%)  7/57 (12.28%) 
Oedema peripheral  1  0/57 (0.00%)  3/57 (5.26%) 
Infections and infestations     
Bronchitis  1  0/57 (0.00%)  3/57 (5.26%) 
Nasopharyngitis  1  0/57 (0.00%)  5/57 (8.77%) 
Urinary tract infection  1  4/57 (7.02%)  4/57 (7.02%) 
Metabolism and nutrition disorders     
Hyperuricaemia  1  2/57 (3.51%)  5/57 (8.77%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/57 (7.02%)  0/57 (0.00%) 
Nervous system disorders     
Headache  1  9/57 (15.79%)  13/57 (22.81%) 
Somnolence  1  1/57 (1.75%)  3/57 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/57 (0.00%)  3/57 (5.26%) 
Dyspnoea  1  1/57 (1.75%)  4/57 (7.02%) 
Vascular disorders     
Haematoma  1  0/57 (0.00%)  3/57 (5.26%) 
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
Publications of Results:
Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation).
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02251717     History of Changes
Other Study ID Numbers: GS-US-337-1406
2014-002121-35 ( EudraCT Number )
First Submitted: September 25, 2014
First Posted: September 29, 2014
Results First Submitted: March 22, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 19, 2018