NCT01635777

Brief Summary

Miltefosine efficacy will be \>85%

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

July 3, 2012

Last Update Submit

July 9, 2012

Conditions

PKDL

Keywords

PKDLmiltefosine

Outcome Measures

Primary Outcomes (1)

  • Cure rate

    12 months after end of treatment

Secondary Outcomes (1)

  • adverse events

    during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group

Study Arms (2)

12 weeks

EXPERIMENTAL

miltefosine 12 weeks

Drug: Miltefosine

8 weeks

EXPERIMENTAL

miltefosine 8 weeks

Drug: Miltefosine

Interventions

MiltefosineDRUG

2.5 mg/kg/day for 12 weeks

12 weeks

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Sciences, Banaras Hindu University,

Varanasi, 221005, India

Location

MeSH Terms

Interventions

miltefosine

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 10, 2012

Study Start

July 1, 2007

Primary Completion

October 1, 2009

Study Completion

December 1, 2010

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

IN(1)