Celgosivir as a Treatment Against Dengue

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborator: Duke-NUS Graduate Medical School

Criteria

Main Inclusion Criteria:

• Fever of ≥ 38°C of ≤ 48 hr duration.

• At least two of the following criteria indicating probable dengue infection:

• Live or work in or recent travel to dengue endemic area

• Nausea and vomiting

• Presence of rash

• Aches and pains, including headache, or retro-orbital, muscle or joint pain

• Positive NS1 strip assay

Main Exclusion Criteria:

• Clinical signs and symptoms for severe dengue

• Patients with certain abnormal laboratory values

• History of presently active intestinal disorders

• Severe diarrhea

• Current usage of anticoagulant drugs

• Other clinically significant acute illness

• History of severe drug and/or food allergies

• Exposure to investigational agent within 30 days prior to study drug administration

• Clinically significant abnormal physical exam unrelated to dengue fever

• Pregnancy