Trial · NCT01122771
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
NCT01122771, Phase 3, Completed, Drugs for Neglected Diseases
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh. Trials, record NCT01122771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01122771
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
- NCT number
- NCT01122771
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 602 participants, actual
- Lead sponsor
- Drugs for Neglected Diseases
- Conditions
- Visceral Leishmaniasis
- Interventions
- Liposomal amphotericin B, liposomal amphotericin B + miltefosine, liposomal amphotericin B + paromomycin, Miltefosine + Paromomycin
- First posted
- 2010-05-13
- Last updated
- 2016-01-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Definitive cure | 6 month post treatment | The primary endpoint variable is definitive cure at month 6, and is defined as no significant clinical signs or symptoms of VL at Day 45 including lack of fever \[axiliary temperature \< 99.5°F\] and at least one of the following: * improved Hb if the patient was anaemic at baseline (Hb\< 8g/dl) * spleen regression if the spleen was palpable on admission and absence of clinical signs and symptoms of VL (fever, weight loss, splenomegaly) at any time during 6 months post treatment period. |
| Secondary | Initial Cure | Day 45 | Initial Cure is defined as no significant clinical signs or symptoms of VL at Day 45 ie lack of fever \[axiliary temp \< 99.5°F and at least one of the following: * improved Hb if the patient was anaemic at baseline (Hb\< 8g/dl) * spleen regression if the spleen was palpable on admission |
| Secondary | Adverse events | Treatment | Assess safety during treatment and follow-up in different healthcare settings * in hospital setting based on clinical adverse events, laboratory parameters during treatment and 6 months follow-up * In UZHC setting based on clinical adverse events, limited laboratory parameters during treatment and 6 months follow-up |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28558062 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01122771
GET https://conductscience.org/api/trials/v1/NCT01122771/registered