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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: |
NCT00803933 |
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Date of registration:
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04/12/2008 |
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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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Trial of DB289 for the Treatment of Stage I African Trypanosomiasis
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Scientific title:
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Phase II b Trial of DB289 for the Treatment of Stage I African Trypanosomiasis |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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111 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00803933 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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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Congo
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Contacts
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Name:
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Victor Kande, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine |
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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 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. -
Age minimum:
15 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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African Trypanosomiasis
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Intervention(s)
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Drug: Pentamidine
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Drug: DB289
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Primary Outcome(s)
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The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.
[Time Frame: 3 months]
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The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.
[Time Frame: 12 day]
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Secondary Outcome(s)
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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.
[Time Frame: 12 day]
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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.
[Time Frame: 6, 12, 24 months]
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Secondary ID(s)
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289-C-006
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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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