NCT00803933|CompletedPhase 2
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
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Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
Sponsor study identifier
interventional
111
1 country
2
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2004
Actual (reported)Study Completion
June 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2005
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
February 2004
Actual (reported)June 2005
Actual (reported)December 4, 2008
Actual (reported)December 8, 2008
Actual (reported)The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
3 months
The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.
12 day
The secondary outcome measure was the incidence rate of adverse events (all Grades combined) during the 7- to 9-day observation period in Treatment Sequence 1 and during the 12-day observation period in Treatment Sequence 2.
12 day
The number and percentage of subjects with parasitological cure, subjects with confirmed (parasitological) treatment failure, and subjects with suspected treatment failure at 6, 12, and 24 months after completion of treatment.
6, 12, 24 months
Pafuramidine maleate (DB289), 100 mg BID orally
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM
CDTC Maluku
Gombé, Kinshasa, Republic of the Congo
Vanga Hospital
Gombé, Kinshasa, Republic of the Congo
Burri C, Yeramian PD, Allen JL, Merolle A, Serge KK, Mpanya A, Lutumba P, Mesu VK, Bilenge CM, Lubaki JP, Mpoto AM, Thompson M, Munungu BF, Manuel F, Josenando T, Bernhard SC, Olson CA, Blum J, Tidwell RR, Pohlig G. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies. PLoS Negl Trop Dis. 2016 Feb 16;10(2):e0004362. doi: 10.1371/journal.pntd.0004362. eCollection 2016 Feb.
Victor Kande, MD
Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine
111 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2008
First Posted
December 8, 2008
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2004
Actual (reported)Study Completion
June 2005
Actual (reported)Last Updated
December 8, 2008
Record last verified: 2008-12
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Source: ClinicalTrials.gov.
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