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Trial record 56 of 65 for:    "Viral Infectious Disease" | "Mycophenolic acid"

Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus

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ClinicalTrials.gov Identifier: NCT00260208
Recruitment Status : Terminated (Study was prematurely terminated due to poor recruitment.)
First Posted : December 1, 2005
Results First Posted : October 26, 2011
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Liver Transplant
Hepatitis C
Interventions Drug: Cyclosporine A
Drug: Tacrolimus
Enrollment 361
Recruitment Details  
Pre-assignment Details 361 patients were randomized, 185 to the cyclosporin A arm and 176 to tacrolimus. Five patients (1 cyclosporine A, 4 tacrolimus) did not receive any dose of study medication and were therefore excluded from the safety population.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges. Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Period Title: Overall Study
Started 184 [1] 172
Intent to Treat (ITT) Population 182 169
Modified ITT 101 96
Completed 137 138
Not Completed 47 34
Reason Not Completed
Subject withdrew consent             11             7
Lost to Follow-up             6             1
Death             12             10
Missing             18             16
[1]
"Started" indicates safety population.
Arm/Group Title Cyclosporin A Tacrolimus Total
Hide Arm/Group Description The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges. Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges. Total of all reporting groups
Overall Number of Baseline Participants 182 169 351
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 182 participants 169 participants 351 participants
54.4  (6.9) 54.4  (7.1) 54.4  (7.0)
[1]
Measure Description: Baseline measurements were based on intent-to-treat population which included all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 182 participants 169 participants 351 participants
< 65 years 163 154 317
≥ 65 years 19 15 34
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 169 participants 351 participants
Female
57
  31.3%
48
  28.4%
105
  29.9%
Male
125
  68.7%
121
  71.6%
246
  70.1%
1.Primary Outcome
Title Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant
Hide Description Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. Logistic regression on the presence of IK>=2 was applied based on central biopsy readings only.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat population (mITT) included patients treated with study drug at least up to 30 days before Month 12 visit and a liver biopsy had to be performed at this visit. Also included were patients with an earlier biopsy that showed an Ishak-Knodell fibrosis score ≥2 and treated at least up to 30 days before that biopsy was taken.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 88 77
Measure Type: Number
Unit of Measure: Participants
63 52
2.Secondary Outcome
Title Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2
Hide Description The number of participants with combined end point of death or graft loss or presented with a Ishak-Knodell fibrosis score (FS) ≥2 was calculated. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had liver retransplant or died. Assessment of hepatic fibrosis was performed with liver biopsies read centrally. Ishak-Knodell FS was used to stage liver disease; 0=none; 1=portal fibrosis (some); 2=portal fibrosis (most); 3=bridging fibrosis (few); 4=bridging fibrosis (many); 5=Incomplete cirrhosis; 6=cirrhosis. Higher score indicates greater fibrosis.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
77 71
3.Secondary Outcome
Title Number of Participants With Fibrosing Cholestatic Hepatitis
Hide Description Fibrosing cholestatic hepatitis (FCH) is characterized by progressive jaundice with a rapid decline in liver function leading to liver failure, most often associated with markedly elevated viral levels detected in the bloodstream (e.g. more than 20 times pre-liver transplantation levels) and in the liver tissue as well. The presence of FCH was reported based on the diagnosis given by the investigator.
Time Frame 1 year post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
9 6
4.Secondary Outcome
Title Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation
Hide Description Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
Death 15 15
Graft loss 8 13
Death or Graft loss 19 23
Graft loss with re-transplantation 3 8
5.Secondary Outcome
Title Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection
Hide Description Treated acute rejection is defined as an acute rejection, clinically suspected, whether biopsy-proven or not, which has been treated and confirmed by the investigator according to the response to therapy. BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. A sub-clinical rejection was defined as a rejection identified by center driven biopsy, i.e. a biopsy performed routinely at some pre-defined time points after transplantation as per center practice in the absence of any clinical signs of rejection.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
Treated acute rejection 28 22
Biopsy prove acute rejection (BPAR) 28 19
Sub-clinical rejection 4 4
6.Secondary Outcome
Title Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)
Hide Description BPAR was defined as a treated acute rejection confirmed by biopsy. The local pathologist graded biopsies according to the Banff (1997) criteria. Graft loss was considered to have occurred when allograft was presumed to be lost if a patient had a liver re-transplant or died.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
45 42
7.Secondary Outcome
Title Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis
Hide Description Cirrhosis was resulted due to the recurrence of the hepatitis C virus infection in the transplanted liver.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
16 17
8.Secondary Outcome
Title Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)
Hide Description Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis.
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) population consisted of all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Measure Type: Number
Unit of Measure: Participants
63 54
9.Secondary Outcome
Title Mean Value of Liver Function Tests at 1 Year Post-transplantation
Hide Description

The mean value (in Units per liter, IU/L) of following tests were calculated at 1 year post-transplant:

  • Serum glutamic pyruvic transaminase (SGPT)
  • Serum Glutamic Oxaloacetic Transaminase (SGOT)
  • Bilirubin
  • Alkaline Phosphate
  • γ-Glutamyltransferase (GGT)
Time Frame 1 year post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. "n" is number participants with assessable data in each category.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 112 115
Mean (Standard Deviation)
Unit of Measure: IU/L
SGPT (n= 112, 112) 100.5  (178.8) 81.7  (82.5)
SGOT (n= 112,112) 92.0  (122.3) 72.8  (98.2)
Bilirubin (n= 111, 115) 40.3  (85.5) 19.3  (27.9)
Alkaline Phosphate (n= 111, 115) 174.7  (152.9) 152.9  (127.3)
GGT (n= 103, 110) 182.2  (224.3) 168.5  (278.7)
10.Secondary Outcome
Title Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant
Hide Description HCV RNA was measured (IU/µL)centrally pre-transplant (Day 1) and at 48 hours (Day 3), Day 8 and 29, Month 6 and 12 post-transplant and concomitantly to any additional biopsies performed.
Time Frame Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all patients as randomized that were transplanted, received at least one dose of study drug and had at least one post-baseline efficacy assessment. "n" in each of the categories is the number of participants with data at the given time point.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 182 169
Mean (Standard Deviation)
Unit of Measure: IU/µL
Day 1 (n=116, 111) 0.71  (0.887) 0.62  (0.809)
Day 3 (n= 136, 120) 0.98  (1.112) 0.91  (1.024)
Day 8 (n= 122, 117) 1.58  (1.569) 1.45  (1.557)
Day 29 (n=128, 109) 2.56  (1.658) 2.74  (1.439)
Month 6 (n=96, 98) 3.45  (1.069) 3.14  (1.332)
Month 12 (n= 85, 88) 3.17  (1.246) 3.13  (1.385)
11.Secondary Outcome
Title Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis
Hide Description Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. An increase of at least 1 stage demonstrated a worsening of the disease, i.e. the transition from one score to the next higher one.
Time Frame Between 1 and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome measure was not analyzed because of premature termination of study.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Mean Fibrosis Score
Hide Description Assessment of hepatic fibrosis was performed with liver biopsies at Day 1, Month 6, 12 and 24, read centrally by two independent pathologists blinded to treatment arm and time of biopsy. Ishak-Knodell score was used to stage liver disease; 0= None; 1= Portal fibrosis (some); 2= Portal fibrosis (most); 3= Bridging fibrosis (few); 4= Bridging fibrosis (many); 5 = Incomplete cirrhosis; 6 = Cirrhosis. Higher score indicates greater fibrosis. The mean score was equivalent to mean of IK at 1 and 2 years (evolution over time).
Time Frame At 1and 2 years and its evolution over time
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not analyzed because of premature termination of study.
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description:
The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cyclosporin A Tacrolimus
Hide Arm/Group Description The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges. Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
All-Cause Mortality
Cyclosporin A Tacrolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclosporin A Tacrolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   148/184 (80.43%)   138/172 (80.23%) 
Blood and lymphatic system disorders     
Anaemia  1  1/184 (0.54%)  1/172 (0.58%) 
Leukopenia  1  0/184 (0.00%)  1/172 (0.58%) 
Lymphadenopathy  1  1/184 (0.54%)  1/172 (0.58%) 
Neutropenia  1  1/184 (0.54%)  0/172 (0.00%) 
Pancytopenia  1  0/184 (0.00%)  2/172 (1.16%) 
Thrombocytopenia  1  2/184 (1.09%)  0/172 (0.00%) 
Cardiac disorders     
Atrial tachycardia  1  1/184 (0.54%)  0/172 (0.00%) 
Cardiac arrest  1  1/184 (0.54%)  2/172 (1.16%) 
Cardiac disorder  1  1/184 (0.54%)  0/172 (0.00%) 
Cardiac failure  1  1/184 (0.54%)  0/172 (0.00%) 
Cardio-respiratory arrest  1  1/184 (0.54%)  0/172 (0.00%) 
Cardiopulmonary failure  1  0/184 (0.00%)  1/172 (0.58%) 
Myocardial infarction  1  0/184 (0.00%)  1/172 (0.58%) 
Pericardial effusion  1  1/184 (0.54%)  0/172 (0.00%) 
Ventricular tachycardia  1  1/184 (0.54%)  0/172 (0.00%) 
Gastrointestinal disorders     
Abdominal adhesions  1  1/184 (0.54%)  0/172 (0.00%) 
Abdominal distension  1  0/184 (0.00%)  1/172 (0.58%) 
Abdominal pain  1  3/184 (1.63%)  9/172 (5.23%) 
Abdominal pain upper  1  1/184 (0.54%)  2/172 (1.16%) 
Abdominal rigidity  1  1/184 (0.54%)  0/172 (0.00%) 
Ascites  1  2/184 (1.09%)  2/172 (1.16%) 
Colitis  1  1/184 (0.54%)  0/172 (0.00%) 
Constipation  1  0/184 (0.00%)  1/172 (0.58%) 
Diarrhoea  1  0/184 (0.00%)  2/172 (1.16%) 
Duodenitis  1  0/184 (0.00%)  1/172 (0.58%) 
Dysphagia  1  1/184 (0.54%)  0/172 (0.00%) 
Epigastric discomfort  1  1/184 (0.54%)  0/172 (0.00%) 
Faeces pale  1  0/184 (0.00%)  1/172 (0.58%) 
Gastrointestinal haemorrhage  1  1/184 (0.54%)  1/172 (0.58%) 
Ileus  1  1/184 (0.54%)  2/172 (1.16%) 
Inguinal hernia  1  1/184 (0.54%)  2/172 (1.16%) 
Inguinal hernia, obstructive  1  1/184 (0.54%)  0/172 (0.00%) 
Intestinal strangulation  1  1/184 (0.54%)  0/172 (0.00%) 
Localised intraabdominal fluid collection  1  0/184 (0.00%)  4/172 (2.33%) 
Mechanical ileus  1  1/184 (0.54%)  0/172 (0.00%) 
Melaena  1  1/184 (0.54%)  0/172 (0.00%) 
Nausea  1  3/184 (1.63%)  1/172 (0.58%) 
Pancreatitis  1  1/184 (0.54%)  1/172 (0.58%) 
Umbilical hernia  1  1/184 (0.54%)  0/172 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/184 (0.54%)  0/172 (0.00%) 
Vomiting  1  6/184 (3.26%)  2/172 (1.16%) 
General disorders     
Asthenia  1  1/184 (0.54%)  0/172 (0.00%) 
Chest pain  1  0/184 (0.00%)  1/172 (0.58%) 
Effusion  1  1/184 (0.54%)  0/172 (0.00%) 
General physical health deterioration  1  0/184 (0.00%)  2/172 (1.16%) 
Hernia  1  1/184 (0.54%)  0/172 (0.00%) 
Hernia obstructive  1  1/184 (0.54%)  1/172 (0.58%) 
Hernia pain  1  0/184 (0.00%)  1/172 (0.58%) 
Impaired healing  1  2/184 (1.09%)  0/172 (0.00%) 
Multi-organ failure  1  2/184 (1.09%)  0/172 (0.00%) 
Non-cardiac chest pain  1  1/184 (0.54%)  1/172 (0.58%) 
Oedema peripheral  1  0/184 (0.00%)  1/172 (0.58%) 
Pain  1  0/184 (0.00%)  1/172 (0.58%) 
Pyrexia  1  13/184 (7.07%)  9/172 (5.23%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/184 (0.00%)  1/172 (0.58%) 
Bile duct necrosis  1  1/184 (0.54%)  1/172 (0.58%) 
Bile duct obstruction  1  1/184 (0.54%)  3/172 (1.74%) 
Bile duct stenosis  1  8/184 (4.35%)  3/172 (1.74%) 
Bile duct stone  1  1/184 (0.54%)  0/172 (0.00%) 
Biliary cirrhosis  1  1/184 (0.54%)  0/172 (0.00%) 
Biliary ischaemia  1  0/184 (0.00%)  1/172 (0.58%) 
Biloma  1  1/184 (0.54%)  2/172 (1.16%) 
Cholangitis  1  9/184 (4.89%)  2/172 (1.16%) 
Cholestasis  1  1/184 (0.54%)  1/172 (0.58%) 
Haemobilia  1  0/184 (0.00%)  1/172 (0.58%) 
Hepatic artery stenosis  1  2/184 (1.09%)  2/172 (1.16%) 
Hepatic artery thrombosis  1  1/184 (0.54%)  3/172 (1.74%) 
Hepatic failure  1  5/184 (2.72%)  1/172 (0.58%) 
Hepatic function abnormal  1  2/184 (1.09%)  3/172 (1.74%) 
Hepatic haemorrhage  1  0/184 (0.00%)  1/172 (0.58%) 
Hepatic infiltration eosinophilic  1  0/184 (0.00%)  1/172 (0.58%) 
Hepatic vein thrombosis  1  0/184 (0.00%)  1/172 (0.58%) 
Hepatitis  1  1/184 (0.54%)  0/172 (0.00%) 
Hepatitis cholestatic  1  0/184 (0.00%)  1/172 (0.58%) 
Hyperbilirubinaemia  1  1/184 (0.54%)  0/172 (0.00%) 
Hypertransaminasaemia  1  1/184 (0.54%)  0/172 (0.00%) 
Ischaemic hepatitis  1  1/184 (0.54%)  0/172 (0.00%) 
Portal vein thrombosis  1  0/184 (0.00%)  1/172 (0.58%) 
Immune system disorders     
Drug hypersensitivity  1  1/184 (0.54%)  0/172 (0.00%) 
Liver transplant rejection  1  11/184 (5.98%)  7/172 (4.07%) 
Transplant rejection  1  2/184 (1.09%)  2/172 (1.16%) 
Infections and infestations     
Abdominal abscess  1  1/184 (0.54%)  2/172 (1.16%) 
Abdominal sepsis  1  0/184 (0.00%)  1/172 (0.58%) 
Abdominal wall abscess  1  0/184 (0.00%)  1/172 (0.58%) 
Bacteraemia  1  0/184 (0.00%)  1/172 (0.58%) 
Bone abscess  1  0/184 (0.00%)  1/172 (0.58%) 
Bronchitis  1  0/184 (0.00%)  1/172 (0.58%) 
Bronchopneumonia  1  1/184 (0.54%)  0/172 (0.00%) 
Cellulitis  1  2/184 (1.09%)  1/172 (0.58%) 
Clostridium difficile colitis  1  0/184 (0.00%)  1/172 (0.58%) 
Cytomegalovirus hepatitis  1  0/184 (0.00%)  2/172 (1.16%) 
Cytomegalovirus infection  1  7/184 (3.80%)  1/172 (0.58%) 
Cytomegalovirus viraemia  1  1/184 (0.54%)  0/172 (0.00%) 
Enterobacter infection  1  1/184 (0.54%)  0/172 (0.00%) 
Enterocolitis infectious  1  1/184 (0.54%)  0/172 (0.00%) 
Escherichia sepsis  1  1/184 (0.54%)  0/172 (0.00%) 
Fungal infection  1  1/184 (0.54%)  0/172 (0.00%) 
Gastroenteritis  1  2/184 (1.09%)  0/172 (0.00%) 
Gastroenteritis viral  1  0/184 (0.00%)  1/172 (0.58%) 
Groin abscess  1  1/184 (0.54%)  0/172 (0.00%) 
Hepatic infection  1  1/184 (0.54%)  0/172 (0.00%) 
Hepatitis C  1  77/184 (41.85%)  65/172 (37.79%) 
Herpes zoster  1  1/184 (0.54%)  0/172 (0.00%) 
Infective exacerbation of chronic obstructive airways disease  1  1/184 (0.54%)  0/172 (0.00%) 
Intervertebral discitis  1  0/184 (0.00%)  1/172 (0.58%) 
Liver abscess  1  3/184 (1.63%)  0/172 (0.00%) 
Lung infection  1  0/184 (0.00%)  1/172 (0.58%) 
Neurological infection  1  1/184 (0.54%)  0/172 (0.00%) 
Osteomyelitis  1  0/184 (0.00%)  1/172 (0.58%) 
Pericarditis fungal  1  0/184 (0.00%)  1/172 (0.58%) 
Peritonitis bacterial  1  1/184 (0.54%)  1/172 (0.58%) 
Pneumonia  1  2/184 (1.09%)  7/172 (4.07%) 
Pneumonia bacterial  1  1/184 (0.54%)  0/172 (0.00%) 
Respiratory tract infection  1  1/184 (0.54%)  0/172 (0.00%) 
Sepsis  1  8/184 (4.35%)  5/172 (2.91%) 
Septic shock  1  0/184 (0.00%)  2/172 (1.16%) 
Sinusitis  1  1/184 (0.54%)  0/172 (0.00%) 
Staphylococcal sepsis  1  0/184 (0.00%)  1/172 (0.58%) 
Tuberculosis liver  1  0/184 (0.00%)  1/172 (0.58%) 
Urinary tract infection  1  1/184 (0.54%)  3/172 (1.74%) 
Wound infection  1  0/184 (0.00%)  1/172 (0.58%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/184 (0.54%)  0/172 (0.00%) 
Biliary anastomosis complication  1  1/184 (0.54%)  4/172 (2.33%) 
Chemical peritonitis  1  2/184 (1.09%)  0/172 (0.00%) 
Collapse of lung  1  1/184 (0.54%)  0/172 (0.00%) 
Complications of transplanted liver  1  3/184 (1.63%)  10/172 (5.81%) 
Gastrointestinal injury  1  0/184 (0.00%)  1/172 (0.58%) 
Graft loss  1  1/184 (0.54%)  1/172 (0.58%) 
Hepatic haematoma  1  3/184 (1.63%)  0/172 (0.00%) 
Incision site haemorrhage  1  1/184 (0.54%)  0/172 (0.00%) 
Incisional hernia  1  3/184 (1.63%)  1/172 (0.58%) 
Limb traumatic amputation  1  0/184 (0.00%)  1/172 (0.58%) 
Post procedural bile leak  1  5/184 (2.72%)  4/172 (2.33%) 
Post procedural haemorrhage  1  2/184 (1.09%)  1/172 (0.58%) 
Postoperative fever  1  1/184 (0.54%)  0/172 (0.00%) 
Procedural site reaction  1  0/184 (0.00%)  1/172 (0.58%) 
Seroma  1  0/184 (0.00%)  1/172 (0.58%) 
Skin laceration  1  0/184 (0.00%)  1/172 (0.58%) 
Spinal compression fracture  1  1/184 (0.54%)  0/172 (0.00%) 
Subdural haematoma  1  1/184 (0.54%)  0/172 (0.00%) 
Therapeutic agent toxicity  1  1/184 (0.54%)  2/172 (1.16%) 
Vascular pseudoaneurysm  1  1/184 (0.54%)  0/172 (0.00%) 
Wound decomposition  1  1/184 (0.54%)  0/172 (0.00%) 
Investigations     
Blood bilirubin increased  1  1/184 (0.54%)  2/172 (1.16%) 
Blood creatine phosphokinase increased  1  1/184 (0.54%)  0/172 (0.00%) 
Blood creatinine increased  1  3/184 (1.63%)  0/172 (0.00%) 
Blood pressure increased  1  1/184 (0.54%)  0/172 (0.00%) 
Hepatic enzyme increased  1  1/184 (0.54%)  2/172 (1.16%) 
Hepatitis C virus test positive  1  1/184 (0.54%)  0/172 (0.00%) 
Liver function test abnormal  1  14/184 (7.61%)  9/172 (5.23%) 
Transaminases increased  1  2/184 (1.09%)  0/172 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/184 (0.54%)  1/172 (0.58%) 
Diabetes mellitus  1  0/184 (0.00%)  4/172 (2.33%) 
Diabetic ketoacidosis  1  0/184 (0.00%)  1/172 (0.58%) 
Fluid overload  1  0/184 (0.00%)  1/172 (0.58%) 
Hyperglycaemia  1  0/184 (0.00%)  1/172 (0.58%) 
Hyperkalaemia  1  1/184 (0.54%)  1/172 (0.58%) 
Hypovolaemia  1  0/184 (0.00%)  1/172 (0.58%) 
Malnutrition  1  1/184 (0.54%)  0/172 (0.00%) 
Type 2 diabetes mellitus  1  1/184 (0.54%)  0/172 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/184 (0.54%)  3/172 (1.74%) 
Myositis  1  0/184 (0.00%)  1/172 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma  1  1/184 (0.54%)  0/172 (0.00%) 
Hepatic cancer metastatic  1  0/184 (0.00%)  1/172 (0.58%) 
Hepatic neoplasm malignant  1  1/184 (0.54%)  1/172 (0.58%) 
Lung neoplasm  1  1/184 (0.54%)  0/172 (0.00%) 
Lung neoplasm malignant  1  1/184 (0.54%)  0/172 (0.00%) 
Lymphoma  1  0/184 (0.00%)  2/172 (1.16%) 
Metastases to lung  1  1/184 (0.54%)  0/172 (0.00%) 
Non-Hodgkin's lymphoma  1  1/184 (0.54%)  0/172 (0.00%) 
Prostate cancer  1  1/184 (0.54%)  0/172 (0.00%) 
Seminoma  1  0/184 (0.00%)  1/172 (0.58%) 
Tongue neoplasm malignant stage unspecified  1  0/184 (0.00%)  1/172 (0.58%) 
Transitional cell carcinoma  1  1/184 (0.54%)  0/172 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1  0/184 (0.00%)  1/172 (0.58%) 
Cerebral ischaemia  1  1/184 (0.54%)  0/172 (0.00%) 
Cerebrovascular accident  1  0/184 (0.00%)  1/172 (0.58%) 
Convulsion  1  2/184 (1.09%)  1/172 (0.58%) 
Dizziness  1  0/184 (0.00%)  2/172 (1.16%) 
Encephalopathy  1  2/184 (1.09%)  0/172 (0.00%) 
Haemorrhage intracranial  1  1/184 (0.54%)  0/172 (0.00%) 
Haemorrhagic stroke  1  1/184 (0.54%)  1/172 (0.58%) 
Headache  1  1/184 (0.54%)  1/172 (0.58%) 
Hypertensive encephalopathy  1  1/184 (0.54%)  0/172 (0.00%) 
Migraine  1  0/184 (0.00%)  1/172 (0.58%) 
Neurological symptom  1  1/184 (0.54%)  0/172 (0.00%) 
Neurotoxicity  1  1/184 (0.54%)  2/172 (1.16%) 
Reversible posterior leukoencephalopathy syndrome  1  1/184 (0.54%)  0/172 (0.00%) 
Somnolence  1  0/184 (0.00%)  1/172 (0.58%) 
Subarachnoid haemorrhage  1  1/184 (0.54%)  1/172 (0.58%) 
Transient ischaemic attack  1  0/184 (0.00%)  1/172 (0.58%) 
Tremor  1  0/184 (0.00%)  1/172 (0.58%) 
Psychiatric disorders     
Alcoholism  1  0/184 (0.00%)  1/172 (0.58%) 
Delirium  1  1/184 (0.54%)  0/172 (0.00%) 
Mental status changes  1  3/184 (1.63%)  1/172 (0.58%) 
Psychotic disorder  1  2/184 (1.09%)  0/172 (0.00%) 
Substance abuse  1  0/184 (0.00%)  1/172 (0.58%) 
Transient psychosis  1  3/184 (1.63%)  0/172 (0.00%) 
Renal and urinary disorders     
Acute prerenal failure  1  0/184 (0.00%)  1/172 (0.58%) 
Anuria  1  0/184 (0.00%)  1/172 (0.58%) 
Nephrotic syndrome  1  1/184 (0.54%)  0/172 (0.00%) 
Renal failure  1  6/184 (3.26%)  3/172 (1.74%) 
Renal failure acute  1  14/184 (7.61%)  6/172 (3.49%) 
Renal impairment  1  2/184 (1.09%)  2/172 (1.16%) 
Renal tubular necrosis  1  1/184 (0.54%)  0/172 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/184 (0.00%)  1/172 (0.58%) 
Acute respiratory failure  1  0/184 (0.00%)  1/172 (0.58%) 
Brain hypoxia  1  0/184 (0.00%)  1/172 (0.58%) 
Chronic obstructive pulmonary disease  1  0/184 (0.00%)  1/172 (0.58%) 
Dyspnoea  1  1/184 (0.54%)  0/172 (0.00%) 
Haemothorax  1  1/184 (0.54%)  0/172 (0.00%) 
Hyperventilation  1  1/184 (0.54%)  0/172 (0.00%) 
Pleural effusion  1  5/184 (2.72%)  2/172 (1.16%) 
Pleurisy  1  0/184 (0.00%)  1/172 (0.58%) 
Pneumonitis  1  1/184 (0.54%)  0/172 (0.00%) 
Pulmonary embolism  1  1/184 (0.54%)  2/172 (1.16%) 
Pulmonary oedema  1  0/184 (0.00%)  1/172 (0.58%) 
Respiratory distress  1  1/184 (0.54%)  0/172 (0.00%) 
Respiratory failure  1  5/184 (2.72%)  5/172 (2.91%) 
Skin and subcutaneous tissue disorders     
Night sweats  1  0/184 (0.00%)  1/172 (0.58%) 
Stasis dermatitis  1  1/184 (0.54%)  0/172 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/184 (0.00%)  2/172 (1.16%) 
Haemodynamic instability  1  1/184 (0.54%)  0/172 (0.00%) 
Hypertension  1  0/184 (0.00%)  1/172 (0.58%) 
Hypertensive crisis  1  1/184 (0.54%)  1/172 (0.58%) 
Hypotension  1  2/184 (1.09%)  0/172 (0.00%) 
Intra-abdominal haematoma  1  1/184 (0.54%)  0/172 (0.00%) 
Intra-abdominal haemorrhage  1  2/184 (1.09%)  2/172 (1.16%) 
Malignant hypertension  1  1/184 (0.54%)  1/172 (0.58%) 
Thrombosis  1  0/184 (0.00%)  1/172 (0.58%) 
Venoocclusive disease  1  0/184 (0.00%)  1/172 (0.58%) 
Venous thrombosis  1  0/184 (0.00%)  1/172 (0.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cyclosporin A Tacrolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   182/184 (98.91%)   167/172 (97.09%) 
Blood and lymphatic system disorders     
Anaemia  1  51/184 (27.72%)  54/172 (31.40%) 
Coagulopathy  1  3/184 (1.63%)  9/172 (5.23%) 
Leukopenia  1  17/184 (9.24%)  10/172 (5.81%) 
Thrombocytopenia  1  23/184 (12.50%)  28/172 (16.28%) 
Gastrointestinal disorders     
Abdominal distension  1  14/184 (7.61%)  7/172 (4.07%) 
Abdominal pain  1  31/184 (16.85%)  44/172 (25.58%) 
Abdominal pain upper  1  9/184 (4.89%)  14/172 (8.14%) 
Ascites  1  31/184 (16.85%)  29/172 (16.86%) 
Constipation  1  64/184 (34.78%)  62/172 (36.05%) 
Diarrhoea  1  41/184 (22.28%)  57/172 (33.14%) 
Dyspepsia  1  15/184 (8.15%)  14/172 (8.14%) 
Nausea  1  55/184 (29.89%)  59/172 (34.30%) 
Vomiting  1  30/184 (16.30%)  25/172 (14.53%) 
General disorders     
Asthenia  1  15/184 (8.15%)  9/172 (5.23%) 
Fatigue  1  24/184 (13.04%)  19/172 (11.05%) 
Generalised oedema  1  12/184 (6.52%)  12/172 (6.98%) 
Non-cardiac chest pain  1  7/184 (3.80%)  13/172 (7.56%) 
Oedema peripheral  1  61/184 (33.15%)  58/172 (33.72%) 
Pyrexia  1  52/184 (28.26%)  47/172 (27.33%) 
Hepatobiliary disorders     
Bile duct stenosis  1  11/184 (5.98%)  12/172 (6.98%) 
Cholestasis  1  10/184 (5.43%)  10/172 (5.81%) 
Hyperbilirubinaemia  1  13/184 (7.07%)  7/172 (4.07%) 
Infections and infestations     
Cytomegalovirus infection  1  16/184 (8.70%)  5/172 (2.91%) 
Hepatitis C  1  19/184 (10.33%)  21/172 (12.21%) 
Nasopharyngitis  1  10/184 (5.43%)  13/172 (7.56%) 
Pneumonia  1  6/184 (3.26%)  15/172 (8.72%) 
Urinary tract infection  1  24/184 (13.04%)  16/172 (9.30%) 
Injury, poisoning and procedural complications     
Incision site pain  1  33/184 (17.93%)  27/172 (15.70%) 
Post procedural bile leak  1  8/184 (4.35%)  9/172 (5.23%) 
Post procedural discharge  1  6/184 (3.26%)  10/172 (5.81%) 
Procedural pain  1  50/184 (27.17%)  59/172 (34.30%) 
Investigations     
Blood bilirubin increased  1  15/184 (8.15%)  6/172 (3.49%) 
Blood creatinine increased  1  35/184 (19.02%)  23/172 (13.37%) 
Blood glucose increased  1  4/184 (2.17%)  9/172 (5.23%) 
Blood potassium decreased  1  10/184 (5.43%)  9/172 (5.23%) 
Haemoglobin decreased  1  8/184 (4.35%)  11/172 (6.40%) 
Liver function test abnormal  1  31/184 (16.85%)  25/172 (14.53%) 
Urine output decreased  1  17/184 (9.24%)  16/172 (9.30%) 
Metabolism and nutrition disorders     
Decreased appetite  1  21/184 (11.41%)  16/172 (9.30%) 
Diabetes mellitus  1  26/184 (14.13%)  28/172 (16.28%) 
Fluid overload  1  11/184 (5.98%)  13/172 (7.56%) 
Hyperglycaemia  1  46/184 (25.00%)  49/172 (28.49%) 
Hyperkalaemia  1  27/184 (14.67%)  28/172 (16.28%) 
Hypoalbuminaemia  1  13/184 (7.07%)  14/172 (8.14%) 
Hypocalcaemia  1  17/184 (9.24%)  17/172 (9.88%) 
Hypokalaemia  1  33/184 (17.93%)  29/172 (16.86%) 
Hypomagnesaemia  1  39/184 (21.20%)  43/172 (25.00%) 
Hyponatraemia  1  11/184 (5.98%)  6/172 (3.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/184 (5.43%)  11/172 (6.40%) 
Back pain  1  38/184 (20.65%)  25/172 (14.53%) 
Muscle spasms  1  11/184 (5.98%)  16/172 (9.30%) 
Musculoskeletal pain  1  13/184 (7.07%)  5/172 (2.91%) 
Pain in extremity  1  11/184 (5.98%)  14/172 (8.14%) 
Nervous system disorders     
Dizziness  1  8/184 (4.35%)  11/172 (6.40%) 
Headache  1  45/184 (24.46%)  39/172 (22.67%) 
Tremor  1  26/184 (14.13%)  30/172 (17.44%) 
Psychiatric disorders     
Agitation  1  16/184 (8.70%)  24/172 (13.95%) 
Anxiety  1  30/184 (16.30%)  21/172 (12.21%) 
Confusional state  1  9/184 (4.89%)  15/172 (8.72%) 
Depression  1  17/184 (9.24%)  16/172 (9.30%) 
Insomnia  1  65/184 (35.33%)  64/172 (37.21%) 
Renal and urinary disorders     
Oliguria  1  22/184 (11.96%)  20/172 (11.63%) 
Renal failure  1  19/184 (10.33%)  18/172 (10.47%) 
Renal failure acute  1  23/184 (12.50%)  16/172 (9.30%) 
Renal impairment  1  21/184 (11.41%)  15/172 (8.72%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  11/184 (5.98%)  11/172 (6.40%) 
Cough  1  14/184 (7.61%)  14/172 (8.14%) 
Dyspnoea  1  22/184 (11.96%)  24/172 (13.95%) 
Pleural effusion  1  25/184 (13.59%)  31/172 (18.02%) 
Pulmonary oedema  1  7/184 (3.80%)  9/172 (5.23%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  21/184 (11.41%)  19/172 (11.05%) 
Rash  1  11/184 (5.98%)  5/172 (2.91%) 
Vascular disorders     
Hypertension  1  92/184 (50.00%)  69/172 (40.12%) 
Hypotension  1  20/184 (10.87%)  15/172 (8.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
This study was prematurely discontinued due to poor recruitment. Since only a small patient group could be analyzed for primary outcome measure, robust conclusions on the effect of the two calcineurin inhibitors on the fibrosis score cannot be drawn.
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study coordinator
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00260208     History of Changes
Other Study ID Numbers: COLO400A2426
First Submitted: November 30, 2005
First Posted: December 1, 2005
Results First Submitted: September 14, 2011
Results First Posted: October 26, 2011
Last Update Posted: December 6, 2011