Trial Outcomes & Findings for Controlled Attenuation Parameter (CAP) in Liver Allografts (NCT NCT02798861)

NCT ID: NCT02798861

Last Updated: 2020-07-31

Results Overview

CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference

• Recruitment status: COMPLETED
• Target enrollment: 160 participants
• Primary outcome timeframe: Baseline (pre-procurement) to 6 months post liver transplant
• Results posted on: 2020-07-31

Participant Flow

Participant milestones

Measure	Allografts Livers assessed before procurement and after implantation.
Overall Study STARTED	160
Overall Study COMPLETED	137
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Measure	Allografts Livers assessed before procurement and after implantation.
Overall Study Lost to Follow-up	22
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Controlled Attenuation Parameter (CAP) in Liver Allografts

Baseline characteristics by cohort

Measure	CAP Assessment n=160 Participants Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
Age, Continuous	37 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	116 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	22 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown	14 Participants n=5 Participants
Region of Enrollment United States	160 participants n=5 Participants
ALT	36 IU/L n=5 Participants
AST	83 IU/L n=5 Participants
BMI	27 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants
CAP	235 dB/m n=5 Participants
LSM	7.25 kPa n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-procurement) to 6 months post liver transplant

Population: Here are considered the allografts that were transplanted and whose recipients consented to participate in study

CAP accuracy in quantification of liver steatosis to be determined using liver biopsies as reference

Outcome measures

Measure	CAP Assessment n=110 Participants Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient.
Controlled Attenuation Parameter (CAP) - Accuracy	220 dB/m Interval 176.0 to 262.0

SECONDARY outcome

Timeframe: Pretransplant to 6 months posttransplant

Population: Here are considered the allografts that were transplanted and whose recipients consented to participate in study

Liver stiffness measurement

Outcome measures

Measure	CAP Assessment n=110 Participants Controlled Attenuation Parameter with Fibroscan 402/530 before liver procurement and after liver transplantation to assess steatosis, and its association with clinical outcomes Fibroscan 402/530: Fibroscan 402/530 obtained before procurement in the donor and at 1 to 6 months post-transplant in the liver recipient.
LSM	6 kPa Interval 4.7 to 8.7

Adverse Events

CAP Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andres Duarte-Rojo

University of Pittsburgh

Phone: 412-647-7922

Email: duarterojoa@pitt.edu

Results disclosure agreements

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