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Cholates Compound for Liver Disease
Phase 2
Waitlist Available
Led By James Trotter, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18 yr to 80 yr
End-stage liver disease patient or Living Liver Donor or Congenital Heart Disease patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial aims to improve the evaluation of patients with advanced liver disease. Currently, the assessment is limited to imaging, liver function tests, and liver biopsy. However, with advancements in treatments and liver transplantation
Who is the study for?
This trial is for adults aged 18 to 80 with end-stage liver disease, living liver donors, or those with congenital heart disease. Participants must be able to give written consent and follow study rules. Only patients with severe fibrosis as shown by specific tests or clinical evidence can join.Check my eligibility
What is being tested?
The trial is testing new quantitative liver function tests using cholates. These tests aim to better evaluate the condition of patients with advanced liver disease and could help in managing their treatment and predicting outcomes more accurately.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort or risks associated with blood draws or other non-invasive testing methods used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I have end-stage liver disease, am a living liver donor, or have congenital heart disease.
Select...
My liver disease is in an advanced stage, indicated by severe scarring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the effectiveness and accuracy of quantitative liver function testing using oral and IV cholate in patients with end-stage liver disease OR in patients who donate a portion of their liver
Secondary outcome measures
Compare presence and extent of the cholate clearances
Other outcome measures
Annual tests to measure changes in liver function
Side effects data
From 2009 Phase 3 trial • 85 Patients • NCT000070209%
Disease progression
9%
Pyrexia
6%
Upper respiratory tract infection
5%
Fracture
5%
Diarrhoea
5%
Convulsion
4%
Lethargy
3%
Dehydration
3%
Abdominal pain
3%
Ascites
3%
Constipation
3%
Urinary tract infection
3%
Cough
3%
Bronchopneumonia
3%
Otitis media
3%
Gastroenteritis viral
3%
Vitamin E deficiency
3%
Epistaxis
1%
Dermatitis allergic
1%
Musculoskeletal chest pain
1%
Ear infection
1%
Respiratory tract infection
1%
Coagulopathy
1%
Gastric ulcer
1%
Pneumoperitoneum
1%
Jaundice
1%
Amino acid level increased
1%
Nasal congestion
1%
Pulmonary congestion
1%
Hypotonia
1%
Abdominal discomfort
1%
Anal fistula
1%
Enteritis
1%
Gastrointestinal haemorrhage
1%
Inguinal hernia
1%
Cholelithiasis
1%
Cholestasis
1%
Portal hypertension
1%
Scoliosis
1%
Vitamin D deficiency
1%
Gastroenteritis
1%
Infection
1%
Rotavirus infection
1%
Injection site inflammation
1%
Malaise
1%
Ovarian cyst
1%
Occult blood
1%
Weight decreased
1%
Iron deficiency anaemia
1%
Apnoea
1%
Rash
1%
Decreased appetite
1%
Iron deficiency
1%
Malnutrition
1%
Nutritional condition abnormal
1%
Respiratory distress
1%
Hallucination
1%
Ovarian failure
1%
Contusion
1%
Pneumonia
1%
Varicella
1%
Respiratory disorder
1%
Nasopharyngitis
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cholic Acid
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cholates CompoundExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,221 Total Patients Enrolled
James Trotter, MDPrincipal InvestigatorBaylor Health Care System
3 Previous Clinical Trials
1,313 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals younger than 70 years old participate in this clinical research?
"This study is seeking individuals who are above 18 years of age and below the age of 80 to participate in the clinical trial."
Answered by AI
Are there currently opportunities for individuals to enroll as participants in this ongoing medical research study?
"I apologize for the misinformation. As per clinicaltrials.gov, this particular trial is not currently seeking patients. It was originally posted on July 1st, 2011 and last updated on January 28th, 2024. However, it's worth noting that there are presently 284 other trials actively enrolling participants at this time."
Answered by AI
Has the Food and Drug Administration granted approval for the usage of Cholates Compound?
"Based on the current assessment by our team at Power, the safety of Cholates Compound is rated as 2. This rating corresponds to a Phase 2 trial where there is some available data supporting its safety, although no evidence yet exists regarding its efficacy."
Answered by AI
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