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Phase IIb Trial of DB289 vs Pentamidine for Stage I African Trypanosomiasis
NCT00803933Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2003
- Primary completion
- Feb 2004
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- pafuramidine
- Conditions
- African trypanosomiasis (HAT)
01
Overview
Phase 2, randomised, open-label trial of pafuramidine in African trypanosomiasis (HAT) (2 arms), sponsored by Immtech Pharmaceuticals, Inc. Primary endpoints: Parasitological cure at 3 months after completion of treatment and Rate of occurrence of Grade 3 or higher adverse events at 12 days. Started Feb 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
DB289
Pafuramidine maleate 100 mg BID orally
Pentamidine
Pentamidine isethionate 4 mg/kg QD IM
03
Who it enrols
Patients aged 15-50 with confirmed early stage T. b. gambiense infection, weighing at least 35 kg. Excludes late stage disease, HIV, significant liver/heart/pulmonary disease, and pregnancy.
04
Endpoints
Primary
Parasitological cure at 3 months after completion of treatment
Rate of occurrence of Grade 3 or higher adverse events
Secondary
Incidence rate of adverse events (all Grades combined)
Number and percentage of subjects with parasitological cure, confirmed treatment failure, and suspected treatment failure
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