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Miltefosine

Phase 2

Primary Visceral Leishmaniasis | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Apr 24, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment151

FDA Designations

No designations recorded

Clinical trial landscape

Miltefosine · 1 trial · 1 indication

Phase 2 1
NCT01067443Clinical 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 AfricaPrimary Visceral Leishmaniasis
COMPLETED151 Analytics
PHASE2COMPLETED
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
Primary Visceral Leishmaniasis
NCT01067443151
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Study Endpoints

Primary Endpoints

Initial cure: proportion cured at Day 28
Day 28

Secondary Endpoints

Final cure: proportion cured at day 210
6 months post treatment
Adverse events and serious adverse events occurring in the three study arms
up to day 60
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Amb+SSGEXPERIMENTALAmBisome® 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+MiltEXPERIMENTALAmBisome® 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
MiltEXPERIMENTALMonotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Interventions

NameTypeDescription
Liposomal amphotericin B (AmBisome®) and sodium stibogluconateDRUGAmBisome® 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 + miltefosineDRUGAmBisome® 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
MiltefosineDRUGMonotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
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Eligibility Criteria

Age Range7 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites3

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...

Countries:KenyaSudan
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Frequently asked questions about Miltefosine

What is Miltefosine used for?

Miltefosine is an investigational small molecule being studied for the treatment of Primary Visceral Leishmaniasis, a parasitic infection. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes Miltefosine?

Miltefosine is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.

What phase is Miltefosine in?

Miltefosine is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. One Phase 2 trial for the drug has been completed.

What clinical trials is Miltefosine in?

Miltefosine was studied in a completed Phase 2 clinical trial with the identifier NCT01067443. This trial assessed the safety and efficacy of Miltefosine alone and in combination with other treatments for Visceral Leishmaniasis in Kenya and Sudan, enrolling 151 participants aged 7 years and older.

How does Miltefosine work?

Miltefosine is a small molecule drug. Its specific molecular target has not been disclosed in the available information.