Ache Lab 
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 6 Products   9 Diseases   6 Products   3 Trials   158 News 
  • ||||||||||  ACH-000029 / Ache Lab, Otsuka
    Enrollment change, Trial termination:  To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects (clinicaltrials.gov) -  Feb 1, 2023   
    P1,  N=8, Terminated, 
    Not yet recruiting --> Recruiting | Trial completion date: Dec 2025 --> Jul 2025 N=24 --> 8 | Recruiting --> Terminated; Based on the unblinded clinical data, the trial was terminated.
  • ||||||||||  Alenia (budesonide/formoterol) / Ache Lab
    Pharmacovigilance in Brazil: safety of budesonide-formoterol (TP-13 in thematic poster area) -  Jun 22, 2022 - Abstract #ERS2022ERS_3900;    
    Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Jul 2022 --> Jan 2023 Considering this analysis, we can conclude that the use of a wide-spread molecule, such as budesonide-formoterol combination in Brazil, was associated with a few occurrence of adverse events and, when reported, were mostly non-serious events.
  • ||||||||||  ACH-000029 / Ache Lab, Otsuka
    Enrollment open:  To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects (clinicaltrials.gov) -  May 23, 2022   
    P1,  N=24, Recruiting, 
    Considering this analysis, we can conclude that the use of a wide-spread molecule, such as budesonide-formoterol combination in Brazil, was associated with a few occurrence of adverse events and, when reported, were mostly non-serious events. Not yet recruiting --> Recruiting
  • ||||||||||  cyclosporine / Generic mfg.
    [VIRTUAL] USE OF ERYTHROPOETIN IN AUTOIMMUNE HEMOLYTIC ANEMIA: A CASE REPORT () -  Oct 27, 2021 - Abstract #HEMO2021HEMO_1698;    
    Introduction Autoimmune hemolytic anemia (AIHA) is a disorder caused by autoantibodies directed against erythrocytes of the self. Diagnosis is made through laboratory tests and clinical evidence of hemolysis. However, it is a clinically heterogeneous disease in clinical and therapeutic terms, which makes its treatment difficult. Case report ASA, female, 74 years old, with a history of systemic arterial hypertension, hypothyroidism, asthma and obesity, using simvastatin, levothyroxine , losartan, hydrochlorthiazide and alenia. Hospitalization history in 2017 for AHAI using corticosteroids and cyclophosphamide. He was hospitalized for severe, symptomatic anemia with progressive dyspnea for five months without bleeding episodes. Laboratory tests showed a hemoglobin concentration of 4.1 g/L and reticulocytopenia of 4,400 mm3/L. The direct Coombs test was positive, immunoglobulin G eluate was reactive in all cells and cryoagglutinins were negative, classifying as warm AHAI. Treatment with prednisone was started, a transfusion of packed red blood cells was performed, and bone marrow was collected. The result of the spinal cord and investigation with CT scans that did not demonstrate findings that supported the idea of ​​a secondary AHAI. As there was no improvement with the use of prednisone, cyclosporine was started. At the outpatient return visit one month later, the patient maintained the reported dyspnea and the tests showed a hemoglobin concentration of 4.5 g/L and cyclosporine 383 ng/mL, within the therapeutic target. Erytopoietin (EPO) was started due to therapeutic failure and liver decompensation side effects of immunosuppressive therapy. One month after starting EPO therapy, the hemoglobin concentration was 6.1 g/dL, reaching 14.5 g/L within three months of treatment. After discontinuing EPO, the hemoglobin concentration remained stable in the last two months of evaluation and the patient had no more symptoms.Discussion AHAI causes decompensated hemolysis caused by the immune system acting against the body itself. In most cases, there is a good reticulocytic response, and the combination of severe hemolysis and medullary response can lead to high peripheral reticulocytosis. Cases of low erythroid response, such as the one shown, with reticulocytopenia, are uncommon and the cause is still uncertain, and may present severe cases due to the lack of compensatory mechanisms. In addition, reticulocytopenia may be associated with bone marrow hyperplasia or hypoplasia, which may indicate an interaction of autoantibodies with bone marrow lineages. Recent studies prove the benefit of EPO administration, with increased reticulocyte count and hemoglobin concentrations. As there are cases of refractoriness to first and second-line treatments using corticosteroids and immunosuppressants, erythropoietin presents itself as a promising therapeutic alternative. The use of erythropoietic stimulation promotes a rapid response to anemia and is less toxic than currently used medications. Therefore, the use of this treatment as a third line was an important tool that changed the prognosis of the patient presented, characterizing a good therapeutic response.
  • ||||||||||  Trezete (ezetimibe/rosuvastatin) / Ache Lab
    Enrollment open:  TREZETE: Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia (clinicaltrials.gov) -  Jun 9, 2021   
    P=N/A,  N=120, Recruiting, 
    Case report ASA, female, 74 years old, with a history of systemic arterial hypertension, hypothyroidism, asthma and obesity, using simvastatin, levothyroxine , losartan, hydrochlorthiazide and alenia. Hospitalization history in 2017 for AHAI using corticosteroids and cyclophosphamide. He was hospitalized for severe, symptomatic anemia with progressive dyspnea for five months without bleeding episodes. Laboratory tests showed a hemoglobin concentration of 4.1 g/L and reticulocytopenia of 4,400 mm3/L. The direct Coombs test was positive, immunoglobulin G eluate was reactive in all cells and cryoagglutinins were negative, classifying as warm AHAI. Treatment with prednisone was started, a transfusion of packed red blood cells was performed, and bone marrow was collected. The result of the spinal cord and investigation with CT scans that did not demonstrate findings that supported the idea of ​​a secondary AHAI. As there was no improvement with the use of prednisone, cyclosporine was started. At the outpatient return visit one month later, the patient maintained the reported dyspnea and the tests showed a hemoglobin concentration of 4.5 g/L and cyclosporine 383 ng/mL, within the therapeutic target. Erytopoietin (EPO) was started due to therapeutic failure and liver decompensation side effects of immunosuppressive therapy. One month after starting EPO therapy, the hemoglobin concentration was 6.1 g/dL, reaching 14.5 g/L within three months of treatment. After discontinuing EPO, the hemoglobin concentration remained stable in the last two months of evaluation and the patient had no more symptoms.Discussion AHAI causes decompensated hemolysis caused by the immune system acting against the body itself. In most cases, there is a good reticulocytic response, and the combination of severe hemolysis and medullary response can lead to high peripheral reticulocytosis. Cases of low erythroid response, such as the one shown, with reticulocytopenia, are uncommon and the cause is still uncertain, and may present severe cases due to the lack of compensatory mechanisms. In addition, reticulocytopenia may be associated with bone marrow hyperplasia or hypoplasia, which may indicate an interaction of autoantibodies with bone marrow lineages. Recent studies prove the benefit of EPO administration, with increased reticulocyte count and hemoglobin concentrations. As there are cases of refractoriness to first and second-line treatments using corticosteroids and immunosuppressants, erythropoietin presents itself as a promising therapeutic alternative. The use of erythropoietic stimulation promotes a rapid response to anemia and is less toxic than currently used medications. Therefore, the use of this treatment as a third line was an important tool that changed the prognosis of the patient presented, characterizing a good therapeutic response. Not yet recruiting --> Recruiting
  • ||||||||||  nitazoxanide / Generic mfg.
    Trial primary completion date:  A Two Week Nitazoxanidebased Quadruple Regimen (clinicaltrials.gov) -  Jan 3, 2018   
    P3,  N=100, Recruiting, 
    Trial completion date: Oct 2018 --> Apr 2020 | Trial primary completion date: Aug 2018 --> Feb 2020 Trial primary completion date: Dec 2017 --> Dec 2022
  • ||||||||||  nitazoxanide / Generic mfg.
    Trial primary completion date:  Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori (clinicaltrials.gov) -  Apr 25, 2017   
    P3,  N=120, Recruiting, 
    Integrating patient navigation into population health management activities for low-income and racial/ethnic minority patients might improve equity of cancer care. Trial primary completion date: Dec 2016 --> Dec 2018
  • ||||||||||  Trezete (ezetimibe/rosuvastatin) / Ache Lab
    Trial completion, Enrollment change, Trial initiation date, Trial primary completion date:  Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia (clinicaltrials.gov) -  Oct 26, 2016   
    P3,  N=129, Completed, 
    Trial primary completion date: Dec 2016 --> Dec 2018 Not yet recruiting --> Completed | N=200 --> 129 | Initiation date: Feb 2012 --> Mar 2013 | Trial primary completion date: Oct 2012 --> Nov 2014
  • ||||||||||  ACH15 / Ache Lab
    Enrollment change, Trial initiation date, Trial termination, Trial primary completion date:  Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug (clinicaltrials.gov) -  Oct 19, 2016   
    P1,  N=22, Terminated, 
    Not yet recruiting --> Completed | N=200 --> 129 | Initiation date: Feb 2012 --> Mar 2013 | Trial primary completion date: Oct 2012 --> Nov 2014 N=60 --> 22 | Initiation date: Apr 2013 --> May 2015 | Not yet recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Apr 2017
  • ||||||||||  nitazoxanide / Generic mfg.
    Trial primary completion date:  A Two Week Nitazoxanidebased Quadruple Regimen (clinicaltrials.gov) -  Oct 18, 2016   
    P3,  N=100, Recruiting, 
    N=60 --> 22 | Initiation date: Apr 2013 --> May 2015 | Not yet recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Apr 2017 Trial primary completion date: Sep 2016 --> Dec 2017
  • ||||||||||  ACH24 / Ache Lab
    Enrollment change, Trial withdrawal:  Efficacy and Safety of ACH24 in the Treatment of Vitiligo (clinicaltrials.gov) -  Mar 16, 2016   
    P3,  N=0, Withdrawn, 
    Trial primary completion date: Dec 2016 --> Dec 2017 N=94 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  nitazoxanide / Generic mfg.
    Trial primary completion date:  A Two Week Nitazoxanidebased Quadruple Regimen (clinicaltrials.gov) -  Mar 10, 2016   
    P3,  N=100, Recruiting, 
    N=94 --> 0 | Not yet recruiting --> Withdrawn Trial primary completion date: Jan 2016 --> Sep 2016