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Celgosivir as a Treatment Against Dengue (CELADEN)

Primary Purpose

Dengue Fever

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
celgosivir
placebo
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dengue Fever

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Celgosivir

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Virological Log Reduction (Virological Endpoint)
Fever Reduction (Clinical Endpoint)

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2012
Last Updated
November 28, 2013
Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01619969
Brief Title
Celgosivir as a Treatment Against Dengue
Acronym
CELADEN
Official Title
Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Duke-NUS Graduate Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celgosivir
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
celgosivir
Other Intervention Name(s)
Bu-Cast
Intervention Description
100 mg capsules, 400 mg loading dose 200 mg bid
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Capsules of identical appearance containing starch
Primary Outcome Measure Information:
Title
Virological Log Reduction (Virological Endpoint)
Time Frame
4 days
Title
Fever Reduction (Clinical Endpoint)
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Safety-Proportion of patients experiencing adverse events and serious adverse events
Description
The proportion of patients experiencing adverse events and serious adverse events
Time Frame
14 days
Title
Quantitative NS1 and NS1 clearance
Description
NS1 non-structural protein 1
Time Frame
14 days
Title
Hematology
Description
Leukocytes, platelets, hematocrit
Time Frame
14 days
Title
Pharmacokinetics - Clearance of drug (L/hr)
Description
Clearance of drug (L/hr)
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subhash Vasudevan, PhD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
27509020
Citation
Sung C, Wei Y, Watanabe S, Lee HS, Khoo YM, Fan L, Rathore AP, Chan KW, Choy MM, Kamaraj US, Sessions OM, Aw P, de Sessions PF, Lee B, Connolly JE, Hibberd ML, Vijaykrishna D, Wijaya L, Ooi EE, Low JG, Vasudevan SG. Extended Evaluation of Virological, Immunological and Pharmacokinetic Endpoints of CELADEN: A Randomized, Placebo-Controlled Trial of Celgosivir in Dengue Fever Patients. PLoS Negl Trop Dis. 2016 Aug 10;10(8):e0004851. doi: 10.1371/journal.pntd.0004851. eCollection 2016 Aug.
Results Reference
derived
PubMed Identifier
24877997
Citation
Low JG, Sung C, Wijaya L, Wei Y, Rathore APS, Watanabe S, Tan BH, Toh L, Chua LT, Hou Y, Chow A, Howe S, Chan WK, Tan KH, Chung JS, Cherng BP, Lye DC, Tambayah PA, Ng LC, Connolly J, Hibberd ML, Leo YS, Cheung YB, Ooi EE, Vasudevan SG. Efficacy and safety of celgosivir in patients with dengue fever (CELADEN): a phase 1b, randomised, double-blind, placebo-controlled, proof-of-concept trial. Lancet Infect Dis. 2014 Aug;14(8):706-715. doi: 10.1016/S1473-3099(14)70730-3. Epub 2014 May 28.
Results Reference
derived

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Celgosivir as a Treatment Against Dengue

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