Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT03823768
Eligibility Criteria:
Inclusion Criteria:
1. Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.
Exclusion Criteria:
1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
2. HIV positive (HIV ab +)
3. Unable to tolerate oral medications
4. Use of another investigational product within thirty days prior to receiving study medication
5. Moderate acute cellular rejection (RAI ≥ 5) within the past month
6. A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
7. Patients taking medications known to induce tremors or dopamine blocking agents
8. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03823768
Study Brief:
Protocol Section:
NCT03823768