Visceral LeishmaniasisPhase 3NCT00628719
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
A Phase 3 study testing Liposomal Amphotericin B and amphotericin B deoxycholate in people with Visceral Leishmaniasis, run by Banaras Hindu University at 1 site in India.
Trial summary
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- Liposomal Amphotericin B and amphotericin B deoxycholate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2008to Mar 2009
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children and adults 2-65 years of age (inclusive) of either gender.
- Diagnosis of VL confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL.
- Biochemical and haematological test values as follows:
- Haemoglobin > 3.5g/100mL
- White blood cell count > 0.75 x109/L
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- Platelet count > 40 x 109/L
- AST, ALT and alkaline phosphatase < 5 times upper normal limit
- Prothrombin time < 4 seconds above control
- Serum creatinine levels - 1.5 times upper normal limit
- Serum potassium levels within normal limits
- HIV negative.
Who cannot join
- A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.
- Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- Proteinuria (> 2+).
- A history of allergy or hypersensitivity to amphotericin B
- Previous treatment for VL within two weeks of enrollment into the study.
- Prior treatment failures with amphotericin B.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.
Read the detailed description
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.
Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates
Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.
- Conditions
- Visceral Leishmaniasis
- Being tested
- Liposomal Amphotericin B, amphotericin B deoxycholate
- Keywords
- Visceral leishmaniasis, India, Liposomal Amphotericin B, Amphotericin B deoxycholate
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Amphotericin BDrug
Also called AmBisome
a single dose of 10 mg/kg of liposomal amphotericin B
amphotericin B deoxycholateDrug
amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | a single dose of 10 mg/kg of liposomal amphotericin B Receives: Drug: Liposomal Amphotericin B |
| 2 | Active comparator | amphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days. Receives: Drug: amphotericin B deoxycholate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final cure rate at six months after the end of treatment
Measured: One year
Secondary outcomes (1)
Initial cure after the end of treatment
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionMar 2009
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 Visceral LeishmaniasisStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Investigators
- Shyam Sundar, MD, Study director, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628719
- Sponsor's protocol ID
- AA KAMRC
- Status last verified
- Apr 2009
- First submitted
- 20 Feb 2008
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12. doi: 10.1056/NEJMoa0903627.
PubMed 20147716
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Controlled, Clinical Trial to Assess the Safety and Efficacy of Single Infusion of Liposomal Amphotericin B in Patients With Visceral Leishmaniasis
- ClinicalTrials.gov ID
- NCT00628719
- Acronym / sponsor ID
- AA KAMRC
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral leishmaniasis, India, Liposomal Amphotericin B, Amphotericin B deoxycholate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Mar 2008 (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 trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.
Detailed description
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of VL in India.
Primary objective: Comparison of the efficacy of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate with regards to final cure rates
Secondary objective:. Comparison of the safety of single dose of 10 mg/kg of liposomal amphotericin B to amphotericin B deoxycholate when administered in the proposed dosage regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Liposomal Amphotericin Ba single dose of 10 mg/kg of liposomal amphotericin B |
| 2 | Active comparator | Drug: amphotericin B deoxycholateamphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days. |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Children and adults 2-65 years of age (inclusive) of either gender.
- Diagnosis of VL confirmed by spleen or bone marrow aspirate.
- Clinical signs and symptoms compatible with VL.
- Biochemical and haematological test values as follows:
- Haemoglobin > 3.5g/100mL
Key exclusion criteria (6 listed)
- A history of intercurrent or concurrent diseases (e.g. chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular or CNS disease; diabetes; tuberculosis; other infectious or major psychiatric diseases) that may introduce variables that affect the outcome of the study.
- Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
- Proteinuria (> 2+).
- A history of allergy or hypersensitivity to amphotericin B
- Previous treatment for VL within two weeks of enrollment into the study.
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 |
|---|---|---|
| Liposomal Amphotericin BAlso: AmBisomea single dose of 10 mg/kg of liposomal amphotericin B | Drug | 1 |
| amphotericin B deoxycholateamphotericin B as a 1x test dose and then at a dose of 1 mg/kg/every other day for a total of 15 doses over 30 days. | Drug | 2 |
Primary outcome
Final cure rate at six months after the end of treatment
Time frame: One year
1 secondary outcome
Initial cure after the end of treatment
Time frame: six months
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 3 Apr 2009.
- Derived from this study: PubMed 20147716Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med. 2010 Feb 11;362(6):504-12. doi: 10.1056/NEJMoa0903627.
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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.
Shyam Sundar, MD study director
Banaras Hindu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal Amphotericin B and amphotericin B deoxycholate in people with Visceral Leishmaniasis, run by Banaras Hindu University 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 12 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 3 Apr 2009. 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 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?
Final cure rate at six months after the end of treatment (time frame: One year). 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 NCT00628719, 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 3 Apr 2009.