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COMPLETEDPHASE2

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

NCT00803933•Immtech Pharmaceuticals, Inc

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.

Eligibility

Age

15 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph node aspirate and greater than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
•2. Patient is 15 to 50 years old
•3. Patient has a minimal weight of 35 kilograms
•4. If the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy):
•1. she is not lactating,
•2. she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and
•3. she agrees to use a medically proven method of contraception (abstinence from sexual intercourse is an acceptable method) from the day of consent on until the end of the observation period (day 7).
•5. Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent

Exclusion Criteria

•1. The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination or a WBC count of \> 5mm-1
•2. Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders (A list of typical signs and symptoms is provided for guidance of the investigator in attachment 1)
•3. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
•4. Withdrawal of consent at any time during the study
•5. Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
•6. The subject has been previously treated for African Trypanosomiasis.
•7. The subject has been previously enrolled in the study. -

Locations (2)

CDTC Maluku

Gombé, Kinshasa, Republic of the Congo

Vanga Hospital

Gombé, Kinshasa, Republic of the Congo

Key Dates

Start Date

February 1, 2003

Primary Completion Date

February 1, 2004

Completion Date

June 1, 2005

Last Updated

December 8, 2008

Enrollment

111

ACTUAL participants

Conditions

African Trypanosomiasis

Interventions

DB289

DRUG

Pentamidine

DRUG

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure

NCT03112655

African TrypanosomiasisAfrican; Trypanosomiasis, West+2 more

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COMPLETEDPHASE2/PHASE3

Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

NCT02184689

Human African Trypanosomiasis (HAT)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Inclusion Criteria

Exclusion Criteria

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure

Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole