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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: |
NCT00370825 |
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Date of registration:
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31/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combination Chemotherapy for the Treatment of Indian Kala-Azar
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Scientific title:
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Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis: Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00370825 |
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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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India
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Contacts
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Name:
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Shyam Sundar, 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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Banaras Hindu University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of active VL with consistent signs and symptoms (e.g., fever,
splenomegaly).
- Confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic
amastigotes.
- Male or female.
- Ages 12 to 65 years.
- Both newly diagnosed cases and patients who have received previous treatment (in the
latter case a 2-week wash-out will be required before starting the study treatment).
- WBC > 1,000/mm3.
- Hemoglobin = 4 g/dL
Exclusion Criteria:
- Pregnancy or breast-feeding.
- HIV positive serology.
- ASAT, ALAT, AP = 3 times upper limit of normal range.
- Bilirubin = 2 times upper limit of normal range.
- Prothrombin time = 5 seconds above control.
- Serum creatinine or BUN = 1.5 times upper limit of normal range.
- Any medical condition or situation that compromises compliance with study procedures.
- HIV
Age minimum:
12 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Visceral Leishmaniasis
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Intervention(s)
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Drug: Combination therapy with AmBisome and miltefosine
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Primary Outcome(s)
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Absence of clinical kala-azar at six month follow up
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Secondary ID(s)
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KAMRC0601
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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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