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Celgosivir as a Treatment Against Dengue

NCT ID: NCT01619969

Last Updated: 2013-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Dengue Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Celgosivir

Group Type EXPERIMENTAL

celgosivir

Intervention Type DRUG

100 mg capsules, 400 mg loading dose 200 mg bid

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Capsules of identical appearance containing starch

Interventions

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celgosivir

100 mg capsules, 400 mg loading dose 200 mg bid

Intervention Type DRUG

placebo

Capsules of identical appearance containing starch

Intervention Type DRUG

Other Intervention Names

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Bu-Cast

Eligibility Criteria

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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

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke-NUS Graduate Medical School

OTHER

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Subhash Vasudevan, PhD

Role: STUDY_DIRECTOR

Duke-NUS Graduate Medical School

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type DERIVED
PMID: 27509020 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24877997 (View on PubMed)

Other Identifiers

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2012/025/E

Identifier Type: -

Identifier Source: org_study_id