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To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

Information source: Bharat Serums and Vaccines Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leishmaniasis, Visceral

Intervention: Amphotericin B Lipid emulsion (Drug); Liposomal Amphotericin B (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bharat Serums and Vaccines Limited

Official(s) and/or principal investigator(s):
Dr. Gautam Daftary, MBBS, Principal Investigator, Affiliation: Bharat Serums and Vaccines Ltd

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).

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months

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

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.

Eligibility

Minimum age: 5 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Locations and Contacts

Muzaffarpur, Bihar 842001, India

Muzaffarpur, Bihar 842003, India

Patna, Bihar 800001, India

Patna, Bihar 800007, India

Additional Information

Starting date: July 2009
Last updated: June 1, 2011

Page last updated: August 20, 2015

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