To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- 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 ]
- 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 ]
| Enrollment: | 500 |
| Study Start Date: | July 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Amphotericin B lipid emulsion
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
Other Name: Amphomul
|
|
Active Comparator: Liposomal Amphotericin B
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
Other Name: AmBisome
|
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 |
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| India | |
| Muzaffarpur, Bihar, India, 842001 | |
| Muzaffarpur, Bihar, India, 842003 | |
| Patna, Bihar, India, 800007 | |
| Patna, Bihar, India, 800001 | |
| Principal Investigator: | Dr. Gautam Daftary, MBBS | Bharat Serums and Vaccines Ltd |
More Information
No publications provided
| Responsible Party: | Dr. Gautam V. Daftary, Bharat Serums and Vaccines Ltd |
| ClinicalTrials.gov Identifier: | NCT00876824 History of Changes |
| Other Study ID Numbers: | BSV-AMBE III-KA-0908 |
| Study First Received: | April 6, 2009 |
| Last Updated: | June 1, 2011 |
| 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 Leishmaniasis, Visceral Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Amphotericin B |
Liposomal amphotericin B Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013