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LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02631772
Recruitment Status : Completed
First Posted : December 16, 2015
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Sofosbuvir/Ledipasvir x 12 weeks
Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Late Cohort, Arm 1 Late Cohort, Arm 2
Hide Arm/Group Description

LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks

LDV/SOF+ribavirin x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Late Cohort, Arm 1 Late Cohort, Arm 2 Total
Hide Arm/Group Description

LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks

LDV/SOF+ribavirin x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
61  (4) 60  (4) 61  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
4
  25.0%
6
  37.5%
10
  31.3%
Male
12
  75.0%
10
  62.5%
22
  68.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  43.8%
2
  12.5%
9
  28.1%
White
9
  56.3%
14
  87.5%
23
  71.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Days since transplant  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 16 participants 16 participants 32 participants
1862  (1309) 2611  (1998) 2237  (1654)
Calculated MELD at Transplant   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 16 participants 16 participants 32 participants
22.3  (6.4) 24.7  (8.7) 23.5  (7.6)
[1]
Measure Description:

MELD (Model for End-Stage Liver Disease) predicts survival for patients with advanced liver disease. Scale range is as follows:

Score Mortality Probability

40 (71.3% mortality) 30-39 (52.6% mortality) 20-29 (19.6% mortality) 10-19 (6.0% mortality) 9 or less (1.9% mortality)

Number of patients with prior HCV Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
7
  43.8%
8
  50.0%
15
  46.9%
Number of subjects with history of depression  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
3
  18.8%
6
  37.5%
9
  28.1%
Number of subjects with history of anemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
6
  37.5%
6
  37.5%
12
  37.5%
Number of subjects with history of leukopenia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
4
  25.0%
3
  18.8%
7
  21.9%
Number of subjects with history of thrombocytopenia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
4
  25.0%
4
  25.0%
8
  25.0%
Number of subjects with history of chronic kidney disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
4
  25.0%
5
  31.3%
9
  28.1%
Number of subjects with history of insomnia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
3
  18.8%
4
  25.0%
7
  21.9%
Type of HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Genotype 1a
13
  81.3%
14
  87.5%
27
  84.4%
Genotype 1b
3
  18.8%
2
  12.5%
5
  15.6%
Number of subjects with resistant mutations  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
NS5A Resistant Mutation
2
  12.5%
0
   0.0%
2
   6.3%
NS5B Resistant Mutation
0
   0.0%
0
   0.0%
0
   0.0%
Number of subjects with a previous transplant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
0
   0.0%
1
   6.3%
1
   3.1%
Number of subjects with CMV positive serostatus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
12
  75.0%
13
  81.3%
25
  78.1%
Percent of participants with Previous Interferon use   [1] 
Measure Type: Number
Unit of measure:  %
Number Analyzed 16 participants 16 participants 32 participants
Previous Interferon use 38 50 14
Stopped interferon prematurely 67 100 12
[1]
Measure Description:

Row 1 is the % of subjects who previously used interferon.

Row 2 is the % of subjects who previously used interferon, that subsequently stopped interferon prematurely.

Number of subjects with Split Liver  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
1
   6.3%
2
  12.5%
3
   9.4%
Number of subjects with an HCV positive donor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
2
  12.5%
0
   0.0%
2
   6.3%
Donor age  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
36  (13) 37  (14) 37  (14)
1.Primary Outcome
Title Treatment Efficacy
Hide Description Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Late Cohort, Arm 1 Late Cohort, Arm 2
Hide Arm/Group Description:

LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks

LDV/SOF+ribavirin x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: % of participants
88 75
2.Secondary Outcome
Title Number of Participants With Virologic Failure
Hide Description Number of participants who had a nonresponse to treatment or a relapse of disease under study.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Late Cohort, Arm 1 Late Cohort, Arm 2
Hide Arm/Group Description:

LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks

LDV/SOF+ribavirin x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Overall Number of Participants Analyzed 16 16
Measure Type: Count of Participants
Unit of Measure: Participants
Nonresponse
0
   0.0%
1
   6.3%
Relapse
1
   6.3%
2
  12.5%
3.Secondary Outcome
Title Hemoglobin Levels
Hide Description Change in hemoglobin levels over the course of the study
Time Frame Week 4, Week 8, Week 12, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Late Cohort, Arm 1 Late Cohort, Arm 2
Hide Arm/Group Description:

LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks

LDV/SOF+ribavirin x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: g/dL
Hemoglobin levels at Week 4 13.1  (2.3) 12.9  (1.5)
Hemoglobin levels at Week 8 13.3  (1.7) 11.2  (1.7)
Hemoglobin levels at Week 12 13.7  (1.9) 12.0  (2.3)
Hemoglobin levels at Week 16 13.6  (1.9) 13.1  (1.9)
Time Frame 36 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Late Cohort, Arm 1 Late Cohort, Arm 2
Hide Arm/Group Description

LDV/SOF monotherapy x 12 weeks

Sofosbuvir/Ledipasvir x 12 weeks

LDV/SOF+ribavirin x 12 weeks

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

All-Cause Mortality
Late Cohort, Arm 1 Late Cohort, Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   1/16 (6.25%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Late Cohort, Arm 1 Late Cohort, Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/16 (25.00%)      12/16 (75.00%)    
Blood and lymphatic system disorders     
Anemia   0/16 (0.00%)  0 2/16 (12.50%)  2
Cardiac disorders     
Cardiac Arrest   1/16 (6.25%)  1 0/16 (0.00%)  0
Intermittent Complete heart block   0/16 (0.00%)  0 1/16 (6.25%)  1
COPD   0/16 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders     
Diarrhea   1/16 (6.25%)  1 0/16 (0.00%)  0
Gastrointestinal Syndrom   0/16 (0.00%)  0 1/16 (6.25%)  1
Melena   0/16 (0.00%)  0 1/16 (6.25%)  1
General disorders     
Recurrent falls when walking   0/16 (0.00%)  0 1/16 (6.25%)  1
Hepatobiliary disorders     
Hepatic Encephalopathy   0/16 (0.00%)  0 1/16 (6.25%)  1
Metabolism and nutrition disorders     
Hyperkalemia   1/16 (6.25%)  1 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders     
Fractured hip   0/16 (0.00%)  0 1/16 (6.25%)  1
Back Pain   0/16 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders     
Acute Kidney Injury   1/16 (6.25%)  1 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Hypertension   1/16 (6.25%)  1 0/16 (0.00%)  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 0%
Late Cohort, Arm 1 Late Cohort, Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/16 (68.75%)      16/16 (100.00%)    
Blood and lymphatic system disorders     
Anemia   0/16 (0.00%)  0 11/16 (68.75%)  11
Gastrointestinal disorders     
Nausea   1/16 (6.25%)  1 3/16 (18.75%)  3
Vomiting   0/16 (0.00%)  0 1/16 (6.25%)  1
Diarrhea   2/16 (12.50%)  2 1/16 (6.25%)  1
General disorders     
Fatigue   4/16 (25.00%)  4 5/16 (31.25%)  5
Insomnia   0/16 (0.00%)  0 2/16 (12.50%)  2
headache   2/16 (12.50%)  2 2/16 (12.50%)  2
Hepatobiliary disorders     
Increased liver function tests   0/16 (0.00%)  0 2/16 (12.50%)  2
Renal and urinary disorders     
Increased creatinine   2/16 (12.50%)  2 7/16 (43.75%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Derek Dubay
Organization: Medical University of South Carolina
Phone: 843-792-3368
EMail: dubay@musc.edu
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02631772     History of Changes
Other Study ID Numbers: IN-US-337-1830
First Submitted: December 14, 2015
First Posted: December 16, 2015
Results First Submitted: March 19, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019