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Open-label, Randomized Clinical Trial in Kenya to Determine the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Vs. Praziquantel in the Treatment of S. Mansoni in Children

The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.

开始日期2009-10-01

申办/合作机构

Kenya Medical Research Institute

[+1]

NCT00764036 / Completed临床1期IIT

Prospective Open Uncontrolled Phase I Study of Compatibility, Safety&Pharmacokinetics of Artesunate, a Semisynthetic Derivative of Artemisinin From the Chinese Herb Artemisia Annua in Patients With Metastatic/Locally Advanced Breast Cancer

The purpose of this study is to evaluation the tolerability of an add-on therapy with artesunate with a duration of 4 weeks in patients with advanced breast cancer.

开始日期2008-10-01

申办/合作机构

Heidelberg University (EMCL)

[+2]

NCT00510159 / Completed临床2/3期

Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children

The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.

开始日期2007-08-01

申办/合作机构

Dafra Pharma NV

100 项与 Dafra Pharma NV 相关的临床结果

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0 项与 Dafra Pharma NV 相关的专利（医药）

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2

项与 Dafra Pharma NV 相关的文献（医药）

2015-01-01·EBioMedicine1区 · 医学

A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer

1区 · 医学

ArticleOA

作者: Kumar, Devinder ; Saeed, Mohamed E M ; Ster, Irina Chis ; Kovacsevics, Hajnalka ; Jansen, Herwig ; Finlayson, Caroline ; Ganapathi, Senthil ; Kremsner, Peter G ; Krishna, Sanjeev ; Efferth, Thomas ; Cowan, Matt

BACKGROUNDArtesunate is an antimalarial agent with broad anti-cancer activity in in vitro and animal experiments and case reports. Artesunate has not been studied in rigorous clinical trials for anticancer effects.AIMTo determine the anticancer effect and tolerability of oral artesunate in colorectal cancer (CRC).METHODSThis was a single centre, randomised, double-blind, placebo-controlled trial. Patients planned for curative resection of biopsy confirmed single primary site CRC were randomised (n = 23) by computer-generated code supplied in opaque envelopes to receive preoperatively either 14 daily doses of oral artesunate (200 mg; n = 12) or placebo (n = 11). The primary outcome measure was the proportion of tumour cells undergoing apoptosis (significant if > 7% showed Tunel staining). Secondary immunohistochemical outcomes assessed these tumour markers: VEGF, EGFR, c-MYC, CD31, Ki67 and p53, and clinical responses.FINDINGS20 patients (artesunate = 9, placebo = 11) completed the trial per protocol. Randomization groups were comparable clinically and for tumour characteristics. Apoptosis in > 7% of cells was seen in 67% and 55% of patients in artesunate and placebo groups, respectively. Using Bayesian analysis, the probabilities of an artesunate treatment effect reducing Ki67 and increasing CD31 expression were 0.89 and 0.79, respectively. During a median follow up of 42 months 1 patient in the artesunate and 6 patients in the placebo group developed recurrent CRC.INTERPRETATIONArtesunate has anti-proliferative properties in CRC and is generally well tolerated.

2014-02-01·Journal of Pharmaceutical Analysis2区 · 医学

LC–UV/MS quality analytics of paediatric artemether formulations

2区 · 医学

ArticleOA

作者: Burvenich, Christian ; Vergote, Valentijn ; D'Hondt, Matthias ; Jansen, Herwig ; Vandercruyssen, Kirsten ; De Spiegeleer, Bart

A highly selective and stability-indicating HPLC-method, combined with appropriate sample preparation steps, is developed for β-artemether assay and profiling of related impurities, including possible degradants, in a complex powder for oral suspension. Following HPLC conditions allowed the required selectivity: a Prevail organic acid (OA) column (250 mm×4.6 mm, 5 μm), flow rate set at 1.5 mL/min combined with a linear gradient (where A=25 mM phosphate buffer (pH 2.5), and B=acetonitrile) from 30% to 75% B in a runtime of 60 min. Quantitative UV-detection was performed at 210 nm. Acetonitrile was applied as extraction solvent for sample preparation. Using acetonitrile-water mixtures as extraction solvent, a compartmental behaviour by a non-solving excipient-bound fraction and an artemether-solubilising free fraction of solvent was demonstrated, making a mobile phase based extraction not a good choice. Method validation showed that the developed HPLC-method is considered to be suitable for its intended regulatory stability-quality characterisation of β-artemether paediatric formulations. Furthermore, LC-MS on references as well as on stability samples was performed allowing identity confirmation of the β-artemether related impurities. MS-fragmentation scheme of β-artemether and its related substances is proposed, explaining the m/z values of the in-source fragments obtained.

100 项与 Dafra Pharma NV 相关的药物交易

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100 项与 Dafra Pharma NV 相关的转化医学

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