Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00802594
Eligibility Criteria:
Inclusion Criteria:
1. The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph and less than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
2. Patient is 16 years old or more
3. Patient has a minimal weight of 45 kilograms
4. If 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), she is not lactating, she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and she agrees to use a medically proven method of contraception (abstinence from sexual intercourse acceptable) from the day of consent on until 7 Days after DB289 treatment completion (Study Day 12).
5. Patient has 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 positive (titer greater than 1/4) latex / IgM test, or a positive latex / T.b.g.
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 or significant ECG anomaly such as elongated QTc (corrected) interval above 430 msec for men or above 450 msec for women, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders.
3. Clinically significant abnormal laboratory value at screening including:
* Prothrombin Time \> 1.25 times upper limit of normal (ULN)
* Liver enzyme AST and ALT \> 2 times ULN
* Total bilirubin \> 1.5 times ULN
* Serum Creatinine \> 1.5 times ULN
4. Traumatic lumbar puncture (i.e. red blood cells visible in CSF)
5. Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
6. Withdrawal of consent at any time during the study
7. Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
8. The subject has been previously treated for African Trypanosomiasis.
9. The subject has been previously enrolled in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00802594
Study Brief:
Protocol Section:
NCT00802594