Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Launched by IMMTECH PHARMACEUTICALS, INC · Dec 5, 2008

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Eligibility criteria

• 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. -