Part B: Treatment Group 4 for Liver Cirrhosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Research Site, Pasadena, CALiver CirrhosisPart B: zibotentan (dose C) + dapagliflozin - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests the safety, effectiveness and tolerability of two drugs to treat cirrhosis with features of portal hypertension.

Eligible Conditions
  • Liver Cirrhosis

Treatment Effectiveness

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: at Week 6 and Week 16

at Week 6
Part A: Absolute change in HVPG from baseline to Week 6.
Part A: Change in systolic and diastolic blood pressure from baseline to Week 6.
Part A: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6. Change in total body fat mass from baseline to Week 6.
Part A: Evaluation of change in body weight (kg) over time course of study. Percentage and absolute change from baseline in body weight at Week 6.
Part A: HVPG response, where a responder is defined as HVPG < 10 mmHg or a reduction in HVPG of ≥ 1.5 mmHg from baseline to Week 6.
Part A: Percent change in HVPG from baseline to Week 6.
Part A: Percentage and absolute change in accumulated dosage of loop-diuretic equivalents use from baseline to Week 6.
Part B: HVPG response, where a responder is defined as at least 20% decrease or a reduction to or below 12 mmHg in HVPG from baseline to Week 6.
Part B: Percentage and absolute change in HVPG from baseline to Week 6.
Week 16
Part B: Change in systolic and diastolic blood pressure from baseline to Week 6 and Week 16.
Part B: Change in total body water, extracellular water and intracellular water volumes from baseline to Week 6 and Week 16. Change in total body fat mass from baseline to Week 6 and Week 16.
Part B: Evaluation of change in body weight (kg) over time course of study. Percentage and absolute change from baseline in body weight at Week 6 and Week 16.
Part B: Percentage and absolute change in accumulated dosage of loop-diuretic equivalents use from baseline to Week 6 and Week 16.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

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

Experimental Treatment

140 Total Participants · 7 Treatment Groups

Primary Treatment: Part B: Treatment Group 4 · Has Placebo Group · Phase 2

Part B: Treatment Group 4
Drug
Experimental Group · 1 Intervention: Part B: zibotentan (dose B) + dapagliflozin · Intervention Types: Drug
Part A: Treatment Group 1
Drug
Experimental Group · 1 Intervention: Part A: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) · Intervention Types: Drug
Part B: Treatment Group 1
Drug
Experimental Group · 1 Intervention: Part B: Placebo (matching zibotentan capsule & matching dapagliflozin tablet) · Intervention Types: Drug
Part B: Treatment Group 2
Drug
Experimental Group · 1 Intervention: Part B: placebo (matching zibotentan capsule) + dapagliflozin · Intervention Types: Drug
Part B: Treatment Group 3
Drug
Experimental Group · 1 Intervention: Part B: zibotentan (dose A) + dapagliflozin · Intervention Types: Drug
Part A: Treatment Group 2
Drug
Experimental Group · 1 Intervention: Part A: zibotentan (dose B) + dapagliflozin · Intervention Types: Drug
Part B: Treatment Group 5
Drug
Experimental Group · 1 Intervention: Part B: zibotentan (dose C) + dapagliflozin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 6 and week 16

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,019 Previous Clinical Trials
240,381,008 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 26 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of bleeding from swollen veins in your body (varices).
You have had heart failure or high output heart failure in the past, which could be due to conditions such as hyperthyroidism or Paget's disease.
You have had a brain disorder called encephalopathy that was graded as moderate or severe.
You have heart failure caused by certain types of heart diseases that require specific treatment other than the one being studied. Examples of such diseases include pericardial disease, amyloidosis, congenital heart disease, primary hypertrophic cardiomyopathy, and cardiomyopathy caused by chemotherapy or infections.
You have a history of fluid buildup in your abdomen.
You have a past occurrence of fluid buildup in your lungs due to liver disease.
You have a history of a rare condition called portopulmonary syndrome.
You have heart failure caused by conditions like hyperthyroidism or Paget's disease that can cause your heart to work too hard.

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.