Celgosivir as a Treatment Against Dengue

Phase 1

Completed

• Conditions: Dengue Fever
• Interventions: Drug: celgosivir; Drug: placebo

• Registration Number: NCT01619969
• Lead Sponsor: Singapore General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-15
• Study Start: 2012-07
• Primary Completion: 2013-03
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-28
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celgosivir	celgosivir	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Virological Log Reduction (Virological Endpoint)	4 days
Fever Reduction (Clinical Endpoint)	4 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics - Clearance of drug (L/hr)	5 days	Clearance of drug (L/hr)
Safety-Proportion of patients experiencing adverse events and serious adverse events	14 days	The proportion of patients experiencing adverse events and serious adverse events
Quantitative NS1 and NS1 clearance	14 days	NS1 non-structural protein 1
Hematology	14 days	Leukocytes, platelets, hematocrit

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore