Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03636659
Other study ID # CR179-17
Secondary ID CTRI/2018/04/013
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2, 2018
Est. completion date April 5, 2019

Study information

Verified date August 2018
Source Aurobindo Pharma Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date April 5, 2019
Est. primary completion date April 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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

- 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.

Exclusion Criteria:

- 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).

- 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

Study Design


Intervention

Drug:
Amphotericin B Liposome
Manufactured for: Auromedics Pharma LLC, USA
AmBisome (Amphotericin B) Liposome
Marketed by: Astellas Pharma US, Inc. USA

Locations

Country Name City State
Bangladesh International Centre for Diarrhoeal Disease Research b Dhaka
India Kala-Azar medical Research Centre Muzaffarpur Bihar
India Rajendra Memorial Research Institute of Medical Sciences Patna Bihar

Sponsors (2)

Lead Sponsor Collaborator
Aurobindo Pharma Ltd Axis Clinicals Limited

Countries where clinical trial is conducted

Bangladesh,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimation of Cmax-ss, Maximum concentration over the steady state dosing interval To establish bioequivalence limits within 80-125 % 05 days
Primary Estimation of AUC0-tau, Area under the plasma concentration time curve over the steady state dosing interval To establish bioequivalence limits within 80-125 % 05 days
Secondary Evaluation of Cmin-ss Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated 05 days
Secondary Evaluation of Cavg-ss Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated 05 days
Secondary Evaluation of tmax-ss Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated 05 days
Secondary Evaluation of Cpd Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated 05 days
Secondary Evaluation of Percentage Fluctuation Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated 05 days
Secondary Evaluation of Swing Summary statistics, ANOVA, Ratio Analysis, 90% Confidence Interval, Inter subject variability and Power will be calculated 05 days
See also
  Status Clinical Trial Phase
Terminated NCT02839603 - Asymptomatic Leishmania Infection in HIV Patients
Completed NCT00370825 - Combination Chemotherapy for the Treatment of Indian Kala-Azar Phase 2
Recruiting NCT05426577 - Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Completed NCT01069198 - A Community Trial for Visceral Leishmaniasis (VL) N/A
Completed NCT00604955 - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Phase 4
Completed NCT01032187 - Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children Phase 4
Completed NCT00371995 - Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar Phase 2
Completed NCT00342823 - Immunogenetics of Visceral Leishmaniasis N/A
Completed NCT04003532 - LAMP Assay for the Diagnosis of Visceral Leishmaniasis
Terminated NCT01980199 - Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan Phase 2
Completed NCT00255567 - Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis Phase 3
Not yet recruiting NCT06118749 - Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study
Recruiting NCT04342715 - A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Completed NCT02431143 - Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa Phase 2
Completed NCT01122771 - Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh Phase 3
Not yet recruiting NCT01566552 - Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis Phase 4
Completed NCT00696969 - Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis Phase 3
Completed NCT00318721 - Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar N/A
Completed NCT00216346 - Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Phase 3
Completed NCT02011958 - Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. Phase 3