Cirrhosis Clinical Trial
Official title:
Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study
This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.
This study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial, of 20mg (or 10mg for participants of East Asian ancestry) of rosuvastatin by mouth, once daily. Participants will be randomized (1:1) to either once daily placebo or once daily rosuvastatin. Patients meeting all eligibility criteria will be assigned to a randomization arm prior to initiation of a 4-week lead-in phase of the study. All participants will undergo a 4-week, open-label active run-in phase to evaluate initial safety and adherence to rosuvastatin. During this active run-phase, all participants will receive target dose rosuvastatin-- 20 mg daily (10 mg daily for participants of East-Asian ancestry). After the active run-in phase, all participants will continue with their pre-assigned randomization (1:1) treatment of rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry) or matching placebo. The total duration of the study will be 96 weeks in the assigned treatment arm plus the 4-week lead-in period. The primary outcome will be the mean change in liver stiffness from the baseline measurement to the end of study liver stiffness, as measured by ultrasound-based vibration-controlled transient elastography (VCTE). There are 10 participating clinical centers, and we anticipate a total of 256 patients will be recruited for the initial lead-in as we estimate 20% of participants may dropout after the lead-in (256 x 0.8 = 204 for randomization into the study drug treatment phase). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05014594 -
Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT
|
Phase 2 | |
Not yet recruiting |
NCT03631147 -
The Effect of Rifaximin on Portal Vein Thrombosis
|
N/A | |
Completed |
NCT04939350 -
Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
|
||
Completed |
NCT02528760 -
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis
|
N/A | |
Recruiting |
NCT05484206 -
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
|
Phase 1 | |
Not yet recruiting |
NCT05538546 -
Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
|
||
Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
Recruiting |
NCT02983968 -
Use of the French Healthcare Insurance Database
|
||
Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
Completed |
NCT02596880 -
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
|
Phase 3 | |
Completed |
NCT02247414 -
Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection
|
Phase 4 | |
Completed |
NCT02016196 -
Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
|
Phase 3 | |
Withdrawn |
NCT01956864 -
Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer
|
Phase 1 | |
Completed |
NCT02113631 -
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
|
N/A | |
Completed |
NCT01362855 -
Advance Care Planning Evaluation in Hospitalized Elderly Patients
|
||
Completed |
NCT01447537 -
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
|
N/A | |
Active, not recruiting |
NCT01205074 -
¹³C-Methacetin Breath Test (MBT) Methodology Study
|
Phase 2/Phase 3 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01231828 -
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
|
N/A |