Leishmaniasis, VisceralPhase 3NCT00876824
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
A Phase 3 study testing Amphotericin B Lipid emulsion and Liposomal Amphotericin B in people with Leishmaniasis, Visceral, run by Bharat Serums and Vaccines Limited at 4 sites in India.
Trial summary
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar). Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Leishmaniasis, Visceral
- What is being tested?
- Amphotericin B Lipid emulsion and Liposomal Amphotericin B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesIndia
- Study dates
- Jul 2009to Jan 2011
- Phase
- Phase 3
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients aged between 5 to 65 years (both inclusive).
- Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly)
- Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by rK39 dipstick test with confirmation by splenic or bone marrow aspirate smear examination.
- Non-pregnant, non-lactating females of age ≥5 years, and woman of childbearing potential who are willing to use acceptable methods of contraception
- Negative Urine pregnancy test (UPT) in all women
Who cannot join
- Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening.
- Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history).
- Concurrent diabetes, tuberculosis or bacterial pneumonia or any other infectious or major psychiatric disease.
- Pregnant or nursing women
- Patients receiving any of the medications prohibited by the study protocol.
- Simultaneous participation in another trial or received any IP <30 days prior to enrolment.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Study site
Muzaffarpur, Bihar, 842001
Study site
Muzaffarpur, Bihar, 842003
Study site
Patna, Bihar, 800001
Study site
Patna, Bihar, 800007
About this study
Official title: A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).
Read the detailed description
Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious, chronic disease that is characterized by irregular fever, anorexia, weight loss, cough, gross enlargement of the spleen and liver, mild anemia and emaciation. This may be preceded by rigors and vomiting. If untreated, Kala-azar, which is the most severe form of Leishmaniasis, has a mortality rate of nearly 100%.
The goal of the project is to establish that a single dose of AMPHOMUL® can be used to achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more affordable than current treatment, and is without the risk of drug resistance.
The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either treatment naive or treatment resistant to other antileishmanial drugs.
- Conditions
- Leishmaniasis, Visceral
- Being tested
- Amphotericin B Lipid emulsion, Liposomal Amphotericin B
- Keywords
- Black Fever, Kala-Azar, Amphotericin B lipid emulsion, Liposomal Amphotericin B
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin B Lipid emulsionDrug
Also called Amphomul
Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis
Liposomal Amphotericin BDrug
Also called AmBisome
Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B lipid emulsion | Experimental | Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion Receives: Drug: Amphotericin B Lipid emulsion |
| Liposomal Amphotericin B | Active comparator | Liposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B Receives: Drug: Liposomal Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months
Measured: Six months after dose administration
Secondary outcomes (1)
To assess the Number of AEs, SAEs, Incidence of IRTs, with no Incidence of nephrotoxicity and hepatotoxicity and no change in the Laboratory values for different parameters
Measured: within 30 to 45 days from drug administration and continue throughout duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, VisceralStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Serums and Vaccines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Technology
- Investigators
- Dr. Gautam Daftary, MBBS, Principal investigator, Bharat Serums and Vaccines Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876824
- Sponsor's protocol ID
- BSV-AMBE III-KA-0908
- Status last verified
- Jun 2011
- First submitted
- 6 Apr 2009
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sundar S, Pandey K, Thakur CP, Jha TK, Das VN, Verma N, Lal CS, Verma D, Alam S, Das P. Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study. PLoS Negl Trop Dis. 2014 Sep 18;8(9):e3169. doi: 10.1371/journal.pntd.0003169. eCollection 2014 Sep.
PubMed 25233346
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric, Randomized, Two Arm, Open Label Phase III Study To Assess Efficacy And Safety Of Infusion Of Amphomul® (Amphotericin B Emulsion) As Compared To Liposomal Amphotericin In Patients Of Visceral Leishmaniasis (Kala Azar)
- ClinicalTrials.gov ID
- NCT00876824
- Acronym / sponsor ID
- BSV-AMBE III-KA-0908
- Conditions
- Leishmaniasis, Visceral
- Keywords
- Black Fever, Kala-Azar, Amphotericin B lipid emulsion, Liposomal Amphotericin B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bharat Serums and Vaccines LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Technology
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Apr 2009 (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.
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).
Detailed description
Visceral Leishmaniasis, which is progressive and fatal if not treated, is an insidious, chronic disease that is characterized by irregular fever, anorexia, weight loss, cough, gross enlargement of the spleen and liver, mild anemia and emaciation. This may be preceded by rigors and vomiting. If untreated, Kala-azar, which is the most severe form of Leishmaniasis, has a mortality rate of nearly 100%.
The goal of the project is to establish that a single dose of AMPHOMUL® can be used to achieve a Definitive cure for Visceral Leishmaniasis leading to a short course therapy. The project will also seek to establish that AMPHOMUL ® is safe, at least as effective and more affordable than current treatment, and is without the risk of drug resistance.
The trial is a Prospective, Multicentric, Randomized, Two Arm, Open label Phase III study to Assess Efficacy and Safety of Infusion of Amphomul® (Amphotericin B Emulsion) as Compared to Liposomal Amphotericin B in Patients of Visceral Leishmaniasis (Kala azar)who are either treatment naive or treatment resistant to other antileishmanial drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B lipid emulsion | Experimental | Drug: Amphotericin B Lipid emulsionAmphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion |
| Liposomal Amphotericin B | Active comparator | Drug: Liposomal Amphotericin BLiposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged between 5 to 65 years (both inclusive).
- Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly)
- Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by rK39 dipstick test with confirmation by splenic or bone marrow aspirate smear examination.
- Non-pregnant, non-lactating females of age ≥5 years, and woman of childbearing potential who are willing to use acceptable methods of contraception
- Negative Urine pregnancy test (UPT) in all women
Key exclusion criteria (6 listed)
- Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening.
- Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history).
- Concurrent diabetes, tuberculosis or bacterial pneumonia or any other infectious or major psychiatric disease.
- Pregnant or nursing women
- Patients receiving any of the medications prohibited by the study protocol.
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 |
|---|---|---|
| Amphotericin B Lipid emulsionAlso: AmphomulAmphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis | Drug | Amphotericin B lipid emulsion |
| Liposomal Amphotericin BAlso: AmBisomeLiposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B | Drug | Liposomal Amphotericin B |
Primary outcome
Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months
Time frame: Six months after dose administration
1 secondary outcome
To assess the Number of AEs, SAEs, Incidence of IRTs, with no Incidence of nephrotoxicity and hepatotoxicity and no change in the Laboratory values for different parameters
Time frame: within 30 to 45 days from drug administration and continue throughout duration of study
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 2 Jun 2011.
- Derived from this study: PubMed 25233346Sundar S, Pandey K, Thakur CP, Jha TK, Das VN, Verma N, Lal CS, Verma D, Alam S, Das P. Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study. PLoS Negl Trop Dis. 2014 Sep 18;8(9):e3169. doi: 10.1371/journal.pntd.0003169. eCollection 2014 Sep.
Related trials for Leishmaniasis, Visceral
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
RecruitingObservational study
LEISH-PED: Study on Leishmaniasis in Children
Leishmania Infantum Disease, Leishmaniasis, Visceral
RecruitingObservational study
Recurrent Visceral Leishmaniasis in HIV Co-Infection
Hiv, Visceral Leishmaniasis
Active, not recruitingObservational study
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Visceral Leishmaniasis
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.
Dr. Gautam Daftary, MBBS principal investigator
Bharat Serums and Vaccines Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amphotericin B Lipid emulsion and Liposomal Amphotericin B in people with Leishmaniasis, Visceral, run by Bharat Serums and Vaccines Limited at 4 sites 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 5 inclusion and 6 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 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months (time frame: Six months after dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876824, which also lists 1 linked publication.
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 2 Jun 2011.