NCT00803933

Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Immtech Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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 that are easily administered and have low toxicity, and might thus be used as tools to support disease control. This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.

Conditions

• African Trypanosomiasis

Interventions

Type	Name	Description
DRUG	DB289	Pafuramidine maleate (DB289), 100 mg BID orally
DRUG	Pentamidine	Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-02-01
• Completion: 2005-06-01
• First posted: 2008-12-08
• Last updated: 2008-12-08

Locations

2 sites across 1 country: Republic of the Congo