The Effects of Carvedilol in Patients with Severe Portal Hypertension with Non-response to Propranolol

A Multi-center, Phase IV Open-label Study to Evaluate the Effects of Carvedilol in Patients with Severe Portal Hypertension and Non-response or Poor Compliance to Propranolol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000624

Enrollment

Registered

2013-01-02

Start date

2013-01-10

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : carvedilol 6.25 mg/day - increasing the dose up to 25 mg/day at intervals of 2 weeks for 6 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) nonrresponder to propranolol used in patients enrolled A Randomized, Multi-center, Phase IV Open-label Study (Cris KCT0000102) to Evaluate the Long-term Effect of Carvedilol versus Propranolol on Reduction in Portal Pressure in Patients with Cirrhosis(CARPE study)" at end of treatment. Patients within 6 months after the end of CARPE study (2)Poor compliance to propranolol in CARPE study. Patients within 6 months with after the end of CARPE study

Exclusion criteria

Exclusion criteria: (1) systolic blood pressure 10 mg/dL (8) srum creatinine = 1.2 mg/dL (9) history of shunt or TIPS (10) IDDM (11) pregnancy, lactation (12) allergy to beta-blocker or alpha-blocker (13) unwilling to sign inform consent (14) Clinical investigator have determined that patient is difficult to perform the clinical trial.

Design outcomes

Primary

Measure	Time frame
reduction of hepatic pressure gradient	—

Secondary

Measure	Time frame
compliance;incidence of variceal bleeding;evaluation of non-invasive test	—

Countries

Korea, Republic of

Contacts

Public ContactTae Yeob Kim

Hanyang University Guri Hospital

Outcome results