NCT01619969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

May 15, 2012

Last Update Submit

November 28, 2013

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (2)

  • Virological Log Reduction (Virological Endpoint)

    4 days

  • Fever Reduction (Clinical Endpoint)

    4 days

Secondary Outcomes (4)

  • Safety-Proportion of patients experiencing adverse events and serious adverse events

    14 days

  • Quantitative NS1 and NS1 clearance

    14 days

  • Hematology

    14 days

  • Pharmacokinetics - Clearance of drug (L/hr)

    5 days

Study Arms (2)

Celgosivir

EXPERIMENTAL
Drug: celgosivir

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

celgosivirDRUG

100 mg capsules, 400 mg loading dose 200 mg bid

Also known as: Bu-Cast
Celgosivir
placeboDRUG

Capsules of identical appearance containing starch

Placebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 27509020DERIVED

  • 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.

    PMID: 24877997DERIVED

MeSH Terms

Conditions

Dengue

Interventions

celgosivir

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Subhash Vasudevan, PhD

    Duke-NUS Graduate Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2012

First Posted

June 15, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

SG(1)