Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03778411 · ClinicalTrials.gov registry record
Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.
A clinical trial of Advanced Chronic Liver Disease, NASH, sponsored by Indiana University.
- Completed
- Registry status
- 298
- Enrollment target
- 1
- Study location
NCT03778411: Completed study of Advanced Chronic Liver Disease, NASH, sponsored by Indiana University.
NCT03778411 is a study of Advanced Chronic Liver Disease, NASH that has completed, run by Indiana University. The registered enrollment target is 298 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03778411, a study of Advanced Chronic Liver Disease, NASH, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- 298 participants
- Enrollment target
- 1
- Study location
Study Summary
Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are post-liver transplant. The association between baseline SS values will be examined in relation to the manifestations of portal hypertension such as esophageal or gastric varices. Specific Aim: To examine the relationship between SS and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD). Proposed Study Design: This is a cross sectional study that evaluates the relationship between SS by VCTE in patients with cACLD and manifestations of portal hypertension.
Primary Outcome
The relationship between splenic stiffness (SS) and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD) will be measured with VCTE by the CAP score. CAP is measured in dB/M, with a score range from 100-400. A score of 225 or less is considered to indicate a normal amount of fat in the liver. As the score increases, the amount of steatosis (fat) in the liver is also thought to be elevated.
Conditions Studied
Interventions
- DEVICE VCTE with splenic stiffness measurement
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2023-03-03 |
What the finished NCT03778411 record still lists
NCT03778411 is an observational study that tracks outcomes without assigning an intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Advanced Chronic Liver Disease, NASH appearing as the primary indexed condition, and to 1 intervention - of which VCTE with splenic stiffness measurement is the first listed.
NCT03778411 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT03778411 about?
NCT03778411 is a clinical study titled "Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.". Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single ce...
What is the current status of trial NCT03778411?
This trial is currently completed. The enrollment target is 298 participants. The study started on 2020-12-01. Estimated completion is 2023-03-03.
What conditions does trial NCT03778411 study?
This clinical trial studies the following conditions: Advanced Chronic Liver Disease, NASH.
What interventions are being tested in trial NCT03778411?
The interventions under investigation include: VCTE with splenic stiffness measurement (DEVICE).
Who is sponsoring clinical trial NCT03778411?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03778411 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06305624 · 298 participants · NA
Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease
- NCT06754215 · 298 participants · NA
Smoking Cessation Intervention Development for Homeless Youth
- NCT06780111 · 298 participants · Phase 1
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
- NCT07209358 · 298 participants · NA
EDX110 Randomized Control Trial for Treatment of DFUs
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI