Safety and Efficacy of Oral Miltefosine in Patients With... | NCT01635777

Studies
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

NCT01635777

Sponsor

AB Foundation

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

37Actual

Phase

Phase 2

Conditions

PKDL

Interventions

Miltefosine
Miltefosine

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Jul 3, 2012

First Submission Date that Met QC Criteria

Jul 9, 2012

First Posted Date

Jul 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Name	Class
World Health Organization	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
12 weeks	Experimental	miltefosine 12 weeks	Drug: Miltefosine
8 weeks	Experimental	miltefosine 8 weeks	Drug: Miltefosine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Miltefosine	Drug	2.5 mg/kg/day for 12 weeks	12 weeks
Miltefosine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cure rate		12 months after end of treatment

Secondary Outcomes

Measure	Description	Time Frame
adverse events	gastrointestinal events: vomiting and diarrhea	during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12 years or older
nodules and papules consistent with post kala-azar dermal leishmaniasis
parasitological confirmation of Leishmania infection

Exclusion Criteria:

platelet count <100x 109/l,
leukocyte count <2.5 x 109/l ,
hemoglobin < 8.0 g/100 ml ,
liver function tests >3 times upper limit of normal range,
bilirubin >2 times upper limit of normal range,
serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range);
any non-compensated or uncontrolled condition,
lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
treatment with any anti-leishmanial drug within the previous 12 weeks.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Medical Sciences, Banaras Hindu University,		Varanasi		221005	India

Intervention Browse Module

MeSH Terms

ID	Term
C039128	miltefosine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided