This trial tests the safety, effectiveness and tolerability of two drugs to treat cirrhosis with features of portal hypertension.
- Liver Cirrhosis
2 Primary · 11 Secondary · Reporting Duration: at Week 6 and Week 16
7 Treatment Groups
Part B: Treatment Group 4
1 of 7
Part A: Treatment Group 1
1 of 7
Part B: Treatment Group 1
1 of 7
Part B: Treatment Group 2
1 of 7
Part B: Treatment Group 3
1 of 7
Part A: Treatment Group 2
1 of 7
Part B: Treatment Group 5
1 of 7
140 Total Participants · 7 Treatment Groups
Primary Treatment: Part B: Treatment Group 4 · Has Placebo Group · Phase 2
Who is running the clinical trial?
Age 18 - 80 · All Participants · 26 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
How many individuals are partaking in the evaluation of this medication?
"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is currently accepting applications, which were first posted on October 31st 2022 and more recently modified on November 21st 2022. The study requires participants from 8 distinct sites for a total of 140 patients." - Anonymous Online Contributor
Are younger individuals eligible to register for this experiment?
"This medical study is seeking participants between the ages of 18 and 80, providing 76 opportunities for younger patients, and 412 potential spots for those aged 65 or above." - Anonymous Online Contributor
Has Part A: Treatment Group 1 been granted approval by the Food and Drug Administration?
"After rigorous assessment, our team at Power determined the safety of Part A: Treatment Group 1 to be a 2. This Phase 2 trial has collected evidence that suggests it is safe but none supporting its efficacy." - Anonymous Online Contributor
How many healthcare facilities are currently partaking in this research endeavor?
"At the moment, 8 distinct medical centers are enrolling participants for this clinical trial. These locations are located in Charleston, Rochester and San Diego among various other cities. To reduce travelling burdens, it is suggested that you select a site closest to your residence if you plan on joining the experiment." - Anonymous Online Contributor
Who is eligible to partake in the research study?
"This medical trial is seeking out 140 individuals, between the ages of 18 and 80 who have been diagnosed with liver cirrhosis. Furthermore, these potential participants must meet a variety of criteria such as not having taken any SGLT2 inhibitors or endothelin receptor antagonists within 30 days prior to enrolment; being on either no or a stable dose of beta blockers without major changes in dosage over the past month; verifying post-menopausal status through documentation and testing; confirmation that they are unable to bear children via hysterectomy or bilateral oophorectomy/salpingectomy (not tubal ligation); possessing Child" - Anonymous Online Contributor
What is the primary aim of this investigation?
"According to the trial sponsor, AstraZeneca, the primary outcome of this experiment will be Part B: HVPG response. Wherein a responder is defined as at least 20% decrease or reduction to 12 mmHg in HVPG from baseline to Week 6. The subsidiary outcomes that researchers are assessing include changes in total body water and fat mass volumes, percentage and absolute change of loop-diuretic equivalents use from baseline to Week 6., and also percentages/absolute change of HVGP from baseline until week six." - Anonymous Online Contributor
Are there any ongoing enlistments for this particular clinical investigation?
"According to clinicaltrials.gov, this experiment is actively recruiting subjects. The trial was initially published on October 31st 2022 and recently edited on November 21st 2022." - Anonymous Online Contributor