Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01067443 | Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa | PHASE2 | COMPLETED | 151 | — | — | Mar 1, 2010 | Jun 1, 2011 | Apr 24, 2017 | 3 | Kenya, Sudan |
| Arm | Type | Description |
|---|---|---|
| Amb+SSG | EXPERIMENTAL | AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11 |
| Amb+Milt | EXPERIMENTAL | AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11 |
| Milt | EXPERIMENTAL | Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 |
| Name | Type | Description |
|---|---|---|
| Liposomal amphotericin B (AmBisome®) and sodium stibogluconate | DRUG | AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11 |
| Liposomal amphotericin B + miltefosine | DRUG | AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11 |
| Miltefosine | DRUG | Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28 |
Inclusion Criteria: * Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy. * Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are ab...