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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00802594 |
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Date of registration:
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03/12/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
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Scientific title:
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Phase II A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis |
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Date of first enrolment:
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August 2001 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00802594 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Angola
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Congo
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Contacts
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Name:
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Christian Burri, MSc, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Swiss Tropical & Public Health Institute |
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Key inclusion & exclusion criteria
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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.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Trypanosomiasis, African
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Intervention(s)
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Drug: DB289
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Primary Outcome(s)
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The primary outcome measure for safety analysis will be the rate of occurrence of Grade 3 or higher adverse events during the observation period.
[Time Frame: Day 12]
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The primary efficacy endpoint is the parasitological cure 24 hours after completion of treatment.
[Time Frame: Day 7]
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Secondary Outcome(s)
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The secondary outcome measure will be the incidence rate of adverse events (all Grades combined) during the observation period (as compared to literature values for pentamidine).
[Time Frame: Day 12]
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A secondary endpoint is the parasitological cure 3, 6, 12, 24 months after completion of treatment.
[Time Frame: 3, 6, 12, 24 months]
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Secondary ID(s)
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289-C-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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