Celgosivir as a Treatment Against Dengue (CELADEN)

Singapore Health Services (SingHealth)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dengue Fever

Treatments: Drug: celgosivir; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01619969

2012/025/E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Celgosivir

Experimental group

Treatment:

Drug: celgosivir

Placebo

Placebo Comparator group

Treatment:

Drug: placebo