Clinical trial NCT01619969: Celgosivir as a Treatment Against Dengue
Official title: Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dengue Fever
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
First posted: 2012-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Virological Log Reduction (Virological Endpoint)
timeFrame: 4 days
measure: Fever Reduction (Clinical Endpoint)
timeFrame: 4 days
Secondary outcomes:
measure: Safety-Proportion of patients experiencing adverse events and serious adverse events
timeFrame: 14 days
measure: Quantitative NS1 and NS1 clearance
timeFrame: 14 days
measure: Hematology
timeFrame: 14 days
measure: Pharmacokinetics - Clearance of drug (L/hr)
timeFrame: 5 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Subhash Vasudevan, PhD
role: STUDY_DIRECTOR
References:
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.
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.