Celgosivir as a Treatment Against Dengue (CELADEN)

This study has been completed.
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01619969
First received: May 15, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Dengue Fever
Drug: celgosivir
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Virological Log Reduction (Virological Endpoint) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Fever Reduction (Clinical Endpoint) [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety-Proportion of patients experiencing adverse events and serious adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    The proportion of patients experiencing adverse events and serious adverse events

  • Quantitative NS1 and NS1 clearance [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    NS1 non-structural protein 1

  • Hematology [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Leukocytes, platelets, hematocrit

  • Pharmacokinetics - Clearance of drug (L/hr) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Clearance of drug (L/hr)


Enrollment: 50
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celgosivir Drug: celgosivir
100 mg capsules, 400 mg loading dose 200 mg bid
Other Name: Bu-Cast
Placebo Comparator: Placebo Drug: placebo
Capsules of identical appearance containing starch

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

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619969

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School
Investigators
Study Director: Subhash Vasudevan, PhD Duke-NUS Graduate Medical School
  More Information

No publications provided

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01619969     History of Changes
Other Study ID Numbers: 2012/025/E
Study First Received: May 15, 2012
Last Updated: November 28, 2013
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Dengue
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014