NCT01619969

Celgosivir as a Treatment Against Dengue

Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.

Detailed description

Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1 to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days. While in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5, patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety assessments.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
DRUG	celgosivir	100 mg capsules, 400 mg loading dose 200 mg bid
DRUG	placebo	Capsules of identical appearance containing starch

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2012-06-15
• Last updated: 2013-12-02

Locations

1 site across 1 country: Singapore