Trypanosomiasis, African Clinical Trial
Official title:
Phase II A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the
last decade, and in many places the demand largely surpasses the capacities of the treatment
centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be
administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There
are currently no drugs which might be used as a tool to support disease control that is
easily administered and has low toxicity.
This study aims to assess the efficacy of DB289, a new, oral drug for treatment of first
stage sleeping sickness. The project will be executed in the framework of an international
consortium consisting of more than a dozen partners from academia, industry, and the
Ministries of Health of Angola and the Democratic Republic of Congo.
This is a single-center, open label, non-controlled Phase IIa trial. Patients with first
stage T.b. gambiense sleeping sickness will receive 100 mg of DB289 orally twice a day for 5
days. Subjects meeting entry criteria will be enrolled at a single site.
A total of 30 patients will be enrolled in this trial. Enrollment is planned to begin third
quarter 2001 and be completed in 2-3 months.
The study will be conducted at the Trypanosomiasis Reference Center, Viana (ICCT), Angola,
and at the Trypanosomiasis Treatment Center in Maluku, Congo.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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