Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01851252 | MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy | PHASE1 | COMPLETED | 19 | — | — | Oct 1, 2013 | Aug 1, 2017 | Dec 20, 2022 | 1 | Israel |
MBT baseline measure will be measured within a week before the anticipated HVPG procedure, but not on the same day. The HVPG will be measured approximately 30 minutes after i.v. propanolol is given and the MBT will be performed approximately one hour later.
MBT baseline measure will be measured within a week before the anticipated HVPG procedure, but not on the same day. The HVPG will be measured approximately 30 minutes after i.v. propanolol is given and the MBT will be performed approximately one hour later.
The MBT will be performed on subjects again after 60 days of oral beta blocker treatment and its results will be compared to previous MBT values.
| Arm | Type | Description |
|---|---|---|
| Methacetin (for BT) before / after Propanolol treatment. | EXPERIMENTAL | The methacetin breath test (MBT) will be performed before and after (within 2 hours) injection of Propanolol (BB) dose and once again after 60 days of oral administration of Propanolol. |
| Name | Type | Description |
|---|---|---|
| Methacetin (with Breath testing device) | DEVICE | The methacetin is enriched with carbon 13, a stable non- radioactive isotope, and has been found to be safe in hundreds of studies. The material is very similar to acetominophen. 75 milligrams (mm) of this material pre- dissolved in water are used. This material undergoes rapid metabolism by the liver. |
Inclusion Criteria: -\> 18 years old (M/F) -Diagnosis of cirrhosis: i. By liver biopsy ii. Or strong suspicion of cirrhosis by accepted criteria for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable spleno...