Visceral LeishmaniasisPhase 1NCT03636659

Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition

A Phase 1 study testing Amphotericin B Liposome and AmBisome (Amphotericin B) Liposome in people with Visceral Leishmaniasis, run by Aurobindo Pharma Ltd at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Visceral Leishmaniasis
What is being tested?: Amphotericin B Liposome and AmBisome (Amphotericin B) Liposome
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 3 sitesin 2 countries
Study dates: 2 May 2018to 5 Apr 2019
Phase: Phase 1
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients aged between 18 to 65 years (both inclusive)
Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration, weight loss and splenomegaly)
Presence of amastigotes (Leishmania Donovani bodies) at screening detected by rK39 dipstick test.
Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, or tubal ligation.
Ability to comply with all study requirements.
Patients with Hb ≥ 6.0 g/dl

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Patients with platelets count ≥ 60,000/mm3
Patients should be immunocompetent (e.g., white blood cell count ≥ 2500/ mm3)
Patients and/ or LAR must be give written informed consent
Patients with clinically acceptable results from all the screening laboratory parameters and investigations.

Who cannot join

Known allergy or hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations.
Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
Pregnant or lactating women
Patients requiring dose adjustment during the study.
Serum creatinine concentration greater than twice the upper limit of normal (ULN), AST or ALT value greater than 10 times the ULN
Patients who are required to be on concomitant therapy with IV fat emulsions, such as total parental nutrition (TPN).

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Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl).
Patient with clinically significant Hematopoietic, renal, hepatic and electrolyte disorders (Low level of Magnesium and potassium) will be excluded as per the discretion of Investigator
Patients with Clinically significant screening laboratory parameters in the opinion of the investigator.
Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
History of uncontrolled diseases, such as thyroidal dysfunction, angina pectoralis, serious cardiac arrhythmias, serious heart failure, neuropsychiatric infection or disease.
Patients with controlled and uncontrolled diabetes mellitus
Patients with Uncontrolled hypertension will be excluded.
Immunocompromised patients will be excluded from participating the study
Patients with known positivity for human immunodeficiency virus (HIV), HBsAg and HCV.
Positive results for drugs of abuse (benzodiazepines, opioids, amphetamines, cannabinoids, cocaine and barbiturates) in urine.
Positive results for alcohol as detected by alcohol breath analyzer.
History of difficulty with donating blood or difficulty in accessibility of veins.
An unusual or abnormal diet, for whatever reason e.g. religious fasting.
History of donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product in the study

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

India2 sites

Kala-Azar medical Research Centre
Muzaffarpur, Bihar, 842001
Rajendra Memorial Research Institute of Medical Sciences
Patna, Bihar, 800007

Other trials in India

Bangladesh1 site

International Centre for Diarrhoeal Disease Research b
Dhaka, 1212

Other trials in Bangladesh

About this study

Official title: Multi-Center, Open-Label, Randomized, Two Treatment, Parallel, Single Period, Multiple-Dose, Steady State, Global Bioequivalence Study of Amphotericin B Liposome for Injection 50mg /Vial in Patients With Visceral Leishmaniasis

Read the detailed description

Multi-Center, Open-Label, Randomized, Two treatment, Parallel, Single period, Multiple-Dose, Steady state, Global Bioequivalence study of Amphotericin B Liposome for Injection 50mg /vial of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) Liposome for Injection 50mg/vial of Astellas Pharma US, inc. in patients with Visceral Leishmaniasis under fed condition.Sufficient number of patients will be enrolled to have 140 evaluable patients. (90 to 100 patients from India and 40 to 50 patients from Bangladesh).

Conditions: Visceral Leishmaniasis
Being tested: Amphotericin B Liposome, AmBisome (Amphotericin B) Liposome
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 LiposomeDrug
Manufactured for: Auromedics Pharma LLC, USA
AmBisome (Amphotericin B) LiposomeDrug
Also called AmBisome
Marketed by: Astellas Pharma US, Inc. USA

Study groups in NCT03636659
Study group	Role	What they receive
Amphotericin B Liposome	Experimental	Amphotericin B Liposome for Injection 50 mg/vial, intravenous infusion at a dose of 3 mg/kg/day, OD for 5 days Receives: Drug: Amphotericin B Liposome
AmBisome Liposome	Active comparator	AmBisome Liposome for Injection 50 mg/ vial, intravenous infusion at a dose of 3 mg/kg/day, OD for 5 days Receives: Drug: AmBisome (Amphotericin B) Liposome

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval
To establish bioequivalence limits within 80-125 %
Measured: 05 days
Estimation of AUC0-tau, Area under the plasma concentration time curve over the steady state dosing interval
To establish bioequivalence limits within 80-125 %
Measured: 05 days

Secondary outcomes (6)

Evaluation of Cmin-ss
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Measured: 05 days
Evaluation of Cavg-ss
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Measured: 05 days
Evaluation of tmax-ss
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Measured: 05 days
Evaluation of Cpd
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Measured: 05 days
Evaluation of Percentage Fluctuation
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Measured: 05 days
Evaluation of Swing
Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated
Measured: 05 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20185 Apr 2019

First posted17 Aug 2018
Study start2 May 2018
Primary completion5 Apr 2019
Study completion5 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03636659
Sponsor's protocol ID: CR179-17
Other IDs: CTRI/2018/04/013350
Status last verified: Aug 2018
First submitted: 6 Aug 2018
Last updated: 26 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Open-Label, Randomized, Two Treatment, Parallel, Single Period, Multiple-Dose, Steady State, Global Bioequivalence Study of Amphotericin B Liposome for Injection 50mg /Vial in Patients With Visceral Leishmaniasis
ClinicalTrials.gov ID: NCT03636659
Acronym / sponsor ID: CR179-17
Conditions: Visceral Leishmaniasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Aurobindo Pharma LtdIndustry (pharma, biotech, devices)
Collaborators: Axis Clinicals Limited
Study start: 2 May 2018 (actual)
Primary completion: 5 Apr 2019 (actual)
Study completion: 5 Apr 2019 (actual)
First posted: 17 Aug 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Amphotericin B Liposome	Experimental	Drug: Amphotericin B LiposomeAmphotericin B Liposome for Injection 50 mg/vial, intravenous infusion at a dose of 3 mg/kg/day, OD for 5 days
AmBisome Liposome	Active comparator	Drug: AmBisome (Amphotericin B) LiposomeAmBisome Liposome for Injection 50 mg/ vial, intravenous infusion at a dose of 3 mg/kg/day, OD for 5 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male and female patients aged between 18 to 65 years (both inclusive)
Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration, weight loss and splenomegaly)
Presence of amastigotes (Leishmania Donovani bodies) at screening detected by rK39 dipstick test.
Female subjects of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e. barrier method, intrauterine device, or tubal ligation.
Ability to comply with all study requirements.

Key exclusion criteria (20 listed)

Known allergy or hypersensitivity reactions to any components of conventional or liposomal Amphotericin B formulations.
Any condition which the investigator thinks may prevent the patient from completing the study therapy and subsequent follow-up.
Pregnant or lactating women
Patients requiring dose adjustment during the study.
Serum creatinine concentration greater than twice the upper limit of normal (ULN), AST or ALT value greater than 10 times the ULN

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 LiposomeManufactured for: Auromedics Pharma LLC, USA	Drug	Amphotericin B Liposome
AmBisome (Amphotericin B) LiposomeAlso: AmBisomeMarketed by: Astellas Pharma US, Inc. USA	Drug	AmBisome Liposome

Primary outcome

Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval
Time frame: 05 days
To establish bioequivalence limits within 80-125 %
Estimation of AUC0-tau, Area under the plasma concentration time curve over the steady state dosing interval
Time frame: 05 days
To establish bioequivalence limits within 80-125 %

6 secondary outcomes

Evaluation of Cmin-ss
Time frame: 05 days
Evaluation of Cavg-ss
Time frame: 05 days
Evaluation of tmax-ss
Time frame: 05 days
Evaluation of Cpd
Time frame: 05 days
Evaluation of Percentage Fluctuation
Time frame: 05 days
Evaluation of Swing
Time frame: 05 days

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 26 Aug 2019.
Individual participant dataSharing planned: No

Related trials for Visceral Leishmaniasis

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
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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.

Nagesh Meda, M.Pharm study chair

Aurobindo Pharma Ltd

Dr. Subhra Lahiri, Ph.D study director

Axis Clinicals Limited

Dr. Sajid Mohd, MD study director

Axis Clinicals Limited

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Amphotericin B Liposome and AmBisome (Amphotericin B) Liposome in people with Visceral Leishmaniasis, run by Aurobindo Pharma Ltd at 3 sites in 2 countries.

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 10 inclusion and 20 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India, Bangladesh. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval (time frame: 05 days). The study lists 2 primary outcomes in all. 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 NCT03636659.

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 26 Aug 2019.