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Trial Outcomes & Findings for Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection (NCT NCT00163657)

NCT ID: NCT00163657

Last Updated: 2017-01-12

Results Overview

Freedom from acute rejection (Banff\>grade 2 with RAI score\>4) or freedom from HCV recurrence (Batts/Ludwig\>Stage 2, or \>Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

312 participants

Primary outcome timeframe

12 months

Results posted on

2017-01-12

Participant Flow

Recruitment period August 15, 2002-March 29, 2004 Recruitment of liver transplant receipeints from centers transplant program

Subjects must be receiving a liver transplant for end stage chronic HCV

Participant milestones

Participant milestones
Measure
Treatment Arm 1
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Overall Study
STARTED
80
79
153
Overall Study
COMPLETED
60
56
116
Overall Study
NOT COMPLETED
20
23
37

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment Arm 1
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Overall Study
Death
12
14
19
Overall Study
graft loss
4
1
2
Overall Study
Withdrawal by Subject
2
3
2
Overall Study
Physician Decision
0
1
1
Overall Study
Non Compliance
1
0
0
Overall Study
Lost to Follow-up
1
3
10
Overall Study
Other reason
0
1
3

Baseline Characteristics

Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment Arm 1
n=80 Participants
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
n=79 Participants
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
n=153 Participants
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Total
n=312 Participants
Total of all reporting groups
Age, Customized
Years
51.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
51.4 years
STANDARD_DEVIATION 7.8 • n=7 Participants
51.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
51.6 years
STANDARD_DEVIATION 7.4 • n=4 Participants
Gender
Female
24 Participants
n=5 Participants
19 Participants
n=7 Participants
44 Participants
n=5 Participants
87 Participants
n=4 Participants
Gender
Male
56 Participants
n=5 Participants
60 Participants
n=7 Participants
109 Participants
n=5 Participants
225 Participants
n=4 Participants
Region of Enrollment
United States
80 Participants
n=5 Participants
79 Participants
n=7 Participants
153 Participants
n=5 Participants
312 Participants
n=4 Participants
Reduce HCV recurrent post liver transplant
80 participants
n=5 Participants
79 participants
n=7 Participants
153 participants
n=5 Participants
312 participants
n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Freedom from acute rejection (Banff\>grade 2 with RAI score\>4) or freedom from HCV recurrence (Batts/Ludwig\>Stage 2, or \>Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"

Outcome measures

Outcome measures
Measure
Treatment Arm 1
n=80 Participants
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
n=79 Participants
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
n=153 Participants
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
69 participants
70 participants
133 participants

PRIMARY outcome

Timeframe: 12 month post transplant

Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence

Outcome measures

Outcome measures
Measure
Treatment Arm 1
n=80 Participants
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
n=79 Participants
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
n=153 Participants
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
39 participants
39 participants
72 participants

Adverse Events

Treatment Arm 1

Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths

Treatment Arm 2

Serious events: 14 serious events
Other events: 79 other events
Deaths: 0 deaths

Treatment Arm 3

Serious events: 14 serious events
Other events: 153 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Treatment Arm 1
n=80 participants at risk
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
n=79 participants at risk
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
n=153 participants at risk
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
General disorders
Death
15.0%
12/80 • Number of events 12 • 24 months
biopsy, labs
17.7%
14/79 • Number of events 14 • 24 months
biopsy, labs
9.2%
14/153 • Number of events 19 • 24 months
biopsy, labs
General disorders
Graft loss
5.0%
4/80 • Number of events 4 • 24 months
biopsy, labs
1.3%
1/79 • Number of events 1 • 24 months
biopsy, labs
1.3%
2/153 • Number of events 2 • 24 months
biopsy, labs

Other adverse events

Other adverse events
Measure
Treatment Arm 1
n=80 participants at risk
Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 2
n=79 participants at risk
Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
Treatment Arm 3
n=153 participants at risk
Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
General disorders
thrombocytopenia
6.2%
5/80 • Number of events 6 • 24 months
biopsy, labs
50.6%
40/79 • Number of events 45 • 24 months
biopsy, labs
52.3%
80/153 • Number of events 85 • 24 months
biopsy, labs
General disorders
neutropenia
3.8%
3/80 • Number of events 4 • 24 months
biopsy, labs
50.6%
40/79 • Number of events 45 • 24 months
biopsy, labs
45.8%
70/153 • Number of events 75 • 24 months
biopsy, labs
General disorders
anemia
5.0%
4/80 • Number of events 5 • 24 months
biopsy, labs
50.6%
40/79 • Number of events 45 • 24 months
biopsy, labs
6.5%
10/153 • Number of events 13 • 24 months
biopsy, labs

Additional Information

Goran Klintmalm, MD Director

Baylor University Medical Center

Phone: 214-820-2050

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60