NCT01954524

A Phase 1, Open-Label Study of Intravenous Sildenafil in Patients With Cirrhosis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and tolerability of a single dose intravenous bolus injection of Sildenafil in patients with moderate to severe cirrhosis and kidney disease will be determined.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	IV bolus injection of Sildenafil	Dose escalation will be performed (in different participants). The doses will be as follows: CTP class B cirrhosis: A single 5 and 10 mg IV bolus injections of Sildenafil. CTP class C cirrhosis: A single 2.5, 5, 8 and 10 mg IV bolus injections of Sildenafil.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-10-01
• Last updated: 2022-11-15

Locations

1 site across 1 country: United States