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

Phase 1

Terminated

• Conditions: Cirrhosis
• Interventions: Drug: IV bolus injection of Sildenafil

• Registration Number: NCT01954524
• Lead Sponsor: University of Maryland, Baltimore

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-26
• Study First Posted: 2013-10-01
• Study Start: 2014-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IV bolus injection of Sildenafil	IV bolus injection of Sildenafil	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with "suspected adverse reaction" of IV Sildenafil that is both "serious" and "unexpected" as a measure of safety and tolerability.	The total time to assess the primary outcome measure will be 48 hours after Sildenafil injection (starting from Sildenafil injection time until 48 hours after Sildenafil injection).

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States