PKDLPhase 2NCT01635777
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
A Phase 2 study testing Miltefosine in people with PKDL, run by AB Foundation at 1 site in India.
Trial summary
Miltefosine efficacy will be >85% Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- PKDL
- What is being tested?
- Miltefosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2007to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years or older
- nodules and papules consistent with post kala-azar dermal leishmaniasis
- parasitological confirmation of Leishmania infection
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Medical Sciences, Banaras Hindu University,
Varanasi, 221005
About this study
Miltefosine efficacy will be >85%
- Conditions
- PKDL
- Being tested
- Miltefosine
- Keywords
- PKDL, miltefosine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
2.5 mg/kg/day for 12 weeks
MiltefosineDrug
2.5 mg/kg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 12 weeks | Experimental | miltefosine 12 weeks Receives: Drug: Miltefosine |
| 8 weeks | Experimental | miltefosine 8 weeks Receives: Drug: Miltefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Measured: 12 months after end of treatment
Secondary outcomes (1)
adverse events
gastrointestinal events: vomiting and diarrhea
Measured: during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2007
- Primary completionOct 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PKDLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635777
- Sponsor's protocol ID
- Z015
- Status last verified
- Jul 2012
- First submitted
- 3 Jul 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
- ClinicalTrials.gov ID
- NCT01635777
- Acronym / sponsor ID
- Z015
- Conditions
- PKDL
- Keywords
- PKDL, miltefosine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AB FoundationUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jul 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Miltefosine efficacy will be >85%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 weeks | Experimental | Drug: Miltefosinemiltefosine 12 weeks |
| 8 weeks | Experimental | Drug: Miltefosinemiltefosine 8 weeks |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 12 years or older
- nodules and papules consistent with post kala-azar dermal leishmaniasis
- parasitological confirmation of Leishmania infection
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miltefosine2.5 mg/kg/day for 12 weeks | Drug | 12 weeks |
| Miltefosine2.5 mg/kg/day for 8 weeks | Drug | 8 weeks |
Primary outcome
Cure rate
Time frame: 12 months after end of treatment
1 secondary outcome
adverse events
Time frame: during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miltefosine in people with PKDL, run by AB Foundation at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: 12 months after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.