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
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting
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
Overall contact:
Mr. Taref Kanthawala, M.Sc., Phone: +91-22-66560900, Ext: 925, Email: taref.kanthawala@bharatserums.com
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, Control: Active Control, 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
Mr. Taref Kanthawala, M.Sc., Phone: +91-22-66560900, Ext: 925, Email: taref.kanthawala@bharatserums.com
Muzaffarpur, Bihar 842001, India; Recruiting
Muzaffarpur, Bihar 842003, India; Recruiting
Patna, Bihar 800007, India; Recruiting
Patna, Bihar 800001, India; Recruiting
Additional Information
Starting date: July 2009
Last updated: October 21, 2009
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