Clinical Trial: Celgosivir as a Treatment Against Dengue

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever

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 Summary: 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.
Sponsor: Singapore General Hospital

Current Primary Outcome:

  • Virological Log Reduction (Virological Endpoint) [ Time Frame: 4 days ]
  • Fever Reduction (Clinical Endpoint) [ Time Frame: 4 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety-Proportion of patients experiencing adverse events and serious adverse events [ Time Frame: 14 days ]
    The proportion of patients experiencing adverse events and serious adverse events
  • Quantitative NS1 and NS1 clearance [ Time Frame: 14 days ]
    NS1 non-structural protein 1
  • Hematology [ Time Frame: 14 days ]
    Leukocytes, platelets, hematocrit
  • Pharmacokinetics - Clearance of drug (L/hr) [ Time Frame: 5 days ]
    Clearance of drug (L/hr)


Original Secondary Outcome:

  • Safety-Proportion of patients experiencing adverse events and serious adverse events [ Time Frame: 14 days ]
    The proportion of patients experiencing adverse events and serious adverse events
  • Quantitative NS1 [ Time Frame: 14 days ]
  • Hematology [ Time Frame: 14 days ]
    Leukocytes, platelets, hematocrit
  • Pharmacokinetics - Clearance of drug (L/hr) [ Time Frame: 5 days ]
    Clearance of drug (L/hr)


Information By: Singapore General Hospital

Dates:
Date Received: May 15, 2012
Date Started: July 2012
Date Completion:
Last Updated: November 28, 2013
Last Verified: November 2013