Celgosivir as a Treatment Against Dengue

Dengue Fever Clinical Trial

— CELADEN  

Official title:

Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619969
• Other study ID #: 2012/025/E
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 15, 2012
• Last updated: November 28, 2013
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Drug:
• celgosivir
100 mg capsules, 400 mg loading dose 200 mg bid
• placebo
Capsules of identical appearance containing starch

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

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

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological Log Reduction (Virological Endpoint)		4 days	No
Primary	Fever Reduction (Clinical Endpoint)		4 days	No
Secondary	Safety-Proportion of patients experiencing adverse events and serious adverse events	The proportion of patients experiencing adverse events and serious adverse events	14 days	Yes
Secondary	Quantitative NS1 and NS1 clearance	NS1 non-structural protein 1	14 days	No
Secondary	Hematology	Leukocytes, platelets, hematocrit	14 days	No
Secondary	Pharmacokinetics - Clearance of drug (L/hr)	Clearance of drug (L/hr)	5 days	No