CTRI/2009/091/000058已完成3 期
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 AmBisome In Patients Of Visceral Leishmaniasis (Kala Azar)
Bharat Serums and Vaccines Ltd0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female patients aged between 5 to 65 years (both inclusive).
- •2.Patient/patient's legally acceptable representative (LAR) is willing and able to give written informed consent to participate in the study.
- •3.Clinical signs and symptoms of Visceral Leishmaniasis (fever of over 2 weeks duration and splenomegaly)
- •4.Presence of amastigotes (Leishmania-Donovani bodies) at prescreening detected by recombinant K39 protein (rK39) dipstick test with confirmation of Kala-azar by splenic or bone marrow aspirate smear examination.
- •5.No previous treatment for Visceral Leishmaniasis within 30 days from screening.
- •6.Non-pregnant, non-lactating females of age equal to or greater than 5 years, and woman of childbearing potential (any woman who has reached menarche) who are willing to use acceptable methods of contraception like long term acting injections ex. Depo-Provera.
- •7.Negative Urine pregnancy test (UPT) in all women physiologically capable of becoming pregnant (any woman who has reached menarche)
- •8.Hemoglobin equal to or greater than 5 g/dL
- •9.White blood cells (WBC) count equal to or greater than 1000/cmm
- •10.Platelet count equal to or greater than 50000/cmm
- •11.Alanine amino transferase (ALT), aspartate amino transferase (AST) and alkaline phosphatase equal to or less than 2.5 times the upper limit of normal (ULN)
- •12.Prothrombin time equal to or less than 4 seconds above the control.
- •13.Normal serum creatinine and serum potassium levels
- •14.Negative tests for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B surface antigen (HBsAg).
排除标准
- •1.Patients with past history of treatment with Amphotericin B or any other drug for Visceral Leishmaniasis within 30 days prior to screening.
- •2.Patients positive for HIV, HCV and HBsAg infection, immunocompromised patients (through history).
- •3.A history or evidence of any concurrent disease that may be serious or life threatening, significant hematological, cardiac, hepatic, renal, respiratory, neurological or metabolic disease or any condition which, in the opinion of the investigator, may constitute a safety concern or interfere with the evaluation of the study objectives or may prevent the patient from the completing study therapy or subsequent follow-up
- •4.Concurrent diabetes, tuberculosis or bacterial pneumonia (on chest X-ray, erythrocyte sedimentation rate (ESR) at screening, past history) or any other infectious or major psychiatric disease.
- •5.Patients with concurrent Malaria will not be included in the trial. Parascreen antigen test for detection of malarial parasites will be performed at screening visit. Patients diagnosed with malaria could be rescreened for enrollment in the trial after adequate treatment of Malaria; and if the parascreen antigen test for detection of malarial parasites is found negative then the patient could be enrolled in the trial.
- •6.History of major surgery within 2 weeks prior to screening
- •7.Blood urea nitrogen (BUN) and serum creatinine >1.5 times ULN, and serum bilirubin >1.5 times ULN
- •8.Proteinurea equal to or greater than 2+
- •9.Pregnant or nursing women
- •10.History of alcoholism or illicit drug use/ abuse, or any condition associated with poor compliance
- •11.Known hypersensitivity to Amphotericin B, inactive ingredients of Amphomul® formulation, inactive ingredients of AmBisome formulation.
- •12.Patients receiving any of the medications prohibited by the study protocol.
- •13.Simultaneous participation in another trial or received any IP less than 30 days prior to enrolment.
- •14.Any condition which in the investigator's opinion may prevent the patient from completing the study therapy or follow-up
研究者
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