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

Sponsor:	Bharat Serums and Vaccines Limited
Collaborator:	Ministry of Science and Technology
Information provided by:	Bharat Serums and Vaccines Limited
ClinicalTrials.gov Identifier:	NCT00876824

Purpose

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).

Condition	Intervention	Phase
Leishmaniasis, Visceral	Drug: Amphotericin B Lipid emulsion Drug: Liposomal Amphotericin B	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis

Drug Information available for: Lipids Amphotericin B

U.S. FDA Resources

Further study details as provided by Bharat Serums and Vaccines Limited:

Primary Outcome Measures:

Clinical and parasitological cure at end of treatment and final cure (no relapse) at six months [ Time Frame: Six months after dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: within 30 to 45 days from drug administration and continue throughout duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	July 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Amphotericin B lipid emulsion: Experimental Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A Drug: Amphotericin B lipid emulsion	Drug: Amphotericin B Lipid emulsion Amphotericin B lipid emulsion (Amphomul) 15 mg/kg on day 1 in group A for treatment of Visceral Leishmaniasis
Liposomal Amphotericin B: Active Comparator Liposomal Amphotericin B in visceral leishmaniasis - 15mg/kg on day 1 in Group B	Drug: Liposomal Amphotericin B Liposomal Amphotericin B in visceral leishmaniasis - 15 mg/kg on day 1 in group B

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

Ages Eligible for Study:	5 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876824

Contacts

Contact: Mr. Taref Kanthawala, M.Sc.

+91-22-66560900 ext 925

taref.kanthawala@bharatserums.com

Locations

India, Bihar
	Recruiting
Muzaffarpur, Bihar, India, 842001
	Recruiting
Muzaffarpur, Bihar, India, 842003
	Recruiting
Patna, Bihar, India, 800007
	Recruiting
Patna, Bihar, India, 800001

Sponsors and Collaborators

Bharat Serums and Vaccines Limited

Ministry of Science and Technology

Investigators

Principal Investigator:

Dr. Gautam Daftary, MBBS

Bharat Serums and Vaccines Ltd

More Information

No publications provided

Responsible Party:	Bharat Serums and Vaccines Ltd ( Dr. Gautam V. Daftary )
Study ID Numbers:	BSV-AMBE III-KA-0908
Study First Received:	April 6, 2009
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00876824 History of Changes
Health Authority:	India: Drugs Controller General of India; India: Ministry of Science and Technology

Keywords provided by Bharat Serums and Vaccines Limited:

Black Fever
Kala-Azar
Amphotericin B lipid emulsion
Liposomal Amphotericin B

Additional relevant MeSH terms:

Leishmaniasis
Abelcet
Anti-Infective Agents
Protozoan Infections
Amphotericin B
Antiprotozoal Agents
Skin Diseases, Parasitic
Skin Diseases
Mastigophora Infections
Liposomal amphotericin B
Pharmacologic Actions

Anti-Bacterial Agents
Antiparasitic Agents
Skin Diseases, Infectious
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Leishmaniasis, Visceral
Sarcomastigophora Infections
Parasitic Diseases
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010