6 completed, 1 withdrawn. 7 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 6, Withdrawn 1 |
| Phase 2 | 2 | Completed 1, Withdrawn 1 |
Follow AmBisome: new trials by email Literature Review of AmBisome trials Research Report on AmBisome
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Bioequivalence of Amphotericin B Liposome for Injection Amphotericin B liposome for injection, AmBisome - Bioequivalence | Phase 1 | Completed | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | 32 | 2023-06-02 | 2023-09-28 |
| Pharmacokinetics and Safety of AmBisome and DKF-5122 AmBisome, DKF-5122 - Invasive Fungal Infections, Neutropenic Fever | Phase 1 | Completed | Dongkook Pharmaceutical Co., Ltd. | 38 | 2020-09-07 | 2023-03-01 |
| Nebulised Liposomal Amphotericin for Invasive Pulmonary Aspergillosis (NAIFI01 Study) Amphotericin B Liposomal 50 MG, Placebo - Invasive Pulmonary Aspergillosis | Phase 1 | Completed | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | 13 | 2019-10-18 | 2023-06-15 |
| Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition Amphotericin B Liposome, AmBisome (Amphotericin B) Liposome - Visceral Leishmaniasis | Phase 1 | Completed | Aurobindo Pharma Ltd | 140 | 2018-05-02 | 2019-08-26 |
| An Bioequivalence Study to Compare Two 2 mg/ml Liposomal Amphotericin B Injections in Healthy Subjects Liposomal Amphotericin B, AmBisome - Normal Healthy Subjects | Phase 1 | Completed | Taiwan Liposome Company | 36 | 2012-02-01 | 2013-11-27 |
| High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals Fluconazole, Amphotericin B - Cryptococcal Meningitis, HIV Infections | Phase 1 / Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 168 | 2010-04-16 | 2021-11-04 |
| SCH708980 With and Without AmBisome for Visceral Leishmaniasis SCH708980 Anti-IL-10 monoclonal, AmBisome - Leishmaniasis, Effects of Immunotherapy | Phase 1 / Phase 2 | Withdrawn | National Institute of Allergy and Infectious Diseases (NIAID) | 2013-08-28 |
Febrile Neutropenia (1) · HIV Infections (1) · Invasive Fungal Infections (1) · Invasive Pulmonary Aspergillosis (1) · Leishmaniasis (1) · Leishmaniasis, Visceral (1) · Meningitis (1) · Meningitis, Cryptococcal (1)
National Institute of Allergy and Infectious Diseases (NIAID) (2) · Aurobindo Pharma Ltd (1) · CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (1) · Dongkook Pharmaceutical Co., Ltd. (1) · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (1) · Taiwan Liposome Company (1)
India (3) · Bangladesh (1) · China (1) · Kenya (1) · Peru (1) · South Africa (1) · South Korea (1) · Spain (1) · Thailand (1) · Uganda (1) · United States (1) · Zimbabwe (1)
David Sacks, PhD (1) · Dr. Dinesh Mondal, MD (1) · Dr. Krishna Pandey, MD (1) · Dr. Sajid Mohd, MD (1) · Dr. Shyam Sundar, MD (1) · Dr. Subhra Lahiri, Ph.D (1) · Nagesh Meda, M.Pharm (1) · Robert A. Larsen, MD (1) · Shyam Sundar, MD (1) · Sonsoles Sancho (1) · Umesh G. Lalloo, MD, FRCP (1) · XiaoAi He (1)