A5020001100- Hemophilia Treatment and Research
- Platelet Disorders and Treatments
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
- Blood Coagulation and Thrombosis Mechanisms
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Diabetes Treatment and Management
- Chronic Myeloid Leukemia Treatments
- HIV/AIDS drug development and treatment
- Pharmacogenetics and Drug Metabolism
- Hepatitis C virus research
- Drug-Induced Hepatotoxicity and Protection
- Pharmacological Effects and Toxicity Studies
- Lipoproteins and Cardiovascular Health
- Diabetes Management and Research
- Connexins and lens biology
- Acne and Rosacea Treatments and Effects
- Antiplatelet Therapy and Cardiovascular Diseases
- Pharmacology and Obesity Treatment
- Atrial Fibrillation Management and Outcomes
- Skin Protection and Aging
- HIV Research and Treatment
- Long-Term Effects of COVID-19
- Biosimilars and Bioanalytical Methods
- Cell Adhesion Molecules Research
- Vasculitis and related conditions
Roche (Switzerland)
2015-2024
Centre hospitalier Emile Roux
2021
Heidelberg University
2017
University Hospital Heidelberg
2017
University of Bonn
1988-2015
Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine
1994
Hôpital Saint-Louis
1994
Emicizumab (ACE910) bridges activated factor IX and X to restore the function of VIII, which is deficient in persons with hemophilia A. This phase 3, multicenter trial assessed once-weekly subcutaneous emicizumab prophylaxis A VIII inhibitors.
Emicizumab is a bispecific monoclonal antibody that bridges activated factor IX and X to replace the function of missing VIII, thereby restoring hemostasis. In phase 3, multicenter trial, we investigated its use as prophylaxis in persons who have hemophilia A without VIII inhibitors.We randomly assigned, 2:2:1 ratio, participants 12 years age or older had been receiving episodic treatment with receive subcutaneous maintenance dose emicizumab 1.5 mg per kilogram body weight week (group A) 3.0...
In rheumatoid arthritis (RA), interleukin-6 (IL-6) concentration is elevated, which may cause reduced cytochrome P450 (CYP) activity and increased exposure (peak plasma area under the concentration-vs.-time curve (AUC)) to certain drugs. Tocilizumab reverse IL-6-induced suppression of CYP3A4 activity. this study, simvastatin was significantly at 1 5 weeks after tocilizumab infusion in 12 patients with RA. The mean effect ratio for AUClast 43% (90% confidence interval (CI), 34–55%) week (day...
Prophylaxis with emicizumab, a subcutaneously administered bispecific humanized monoclonal antibody, promotes effective hemostasis in persons hemophilia A (PwHAs). The primary efficacy, safety, and pharmacokinetics of emicizumab were reported previously, but long-term data limited. Here, from 401 pediatric adult PwHAs with/without factor VIII (FVIII) inhibitors who enrolled the phase 3 HAVEN 1, 2, 3, 4 studies (NCT02622321, NCT02795767, NCT02847637, NCT03020160) have been pooled to establish...
Abstract Emicizumab, a bispecific monoclonal antibody, bridges activated factor IX (FIXa) and FX, replacing the function of missing FVIIIa to restore effective hemostasis in persons with hemophilia A (PwHA). Here we assess pharmacokinetic (PK) pharmacodynamic (PD) biomarkers PwHA FVIII inhibitors Phase III HAVEN 1 study (NCT02622321). Blood samples from 112 receiving 1.5 mg/kg once-weekly subcutaneous emicizumab were analyzed at central laboratories. Emicizumab concentrations for PK analysis...
Emicizumab is a subcutaneously administered humanized, bispecific, monoclonal antibody approved for prophylaxis in people with hemophilia A.
Subcutaneous emicizumab enables prophylaxis for people with hemophilia A (HA) from birth, potentially reducing risk of bleeding and intracranial hemorrhage (ICH). HAVEN 7 (NCT04431726) is the first clinical trial dedicated to infants, designed investigate efficacy, safety, pharmacokinetics, pharmacodynamics in those aged ≤12 months severe HA without factor VIII (FVIII) inhibitors. Participants this phase 3b received 3 mg/kg maintenance dose every 2 weeks 52 are continuing during 7-year...
Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I-I/II studies, emicizumab reduced bleeding frequency in patients with severe hemophilia A, regardless presence VIII inhibitors, at once-weekly subcutaneous doses 0.3, 1, and 3 mg/kg.
Aims To investigate the pharmacodynamics, pharmacokinetics and safety of multiple ascending doses RG 7697, a dual glucose‐dependent insulinotropic polypeptide/glucagon‐like peptide‐1 agonist, in patients with type 2 diabetes mellitus (T2 D ). Methods A total 56 T2 received once‐daily subcutaneous (s.c.) injection 7697 (0.25‐2.5 mg) or placebo for 14 days randomized, double‐blind, dose‐escalation study. Adverse events ( AE s), vital signs, ECG s routine laboratory variables were intensively...
Emicizumab is a humanised, bispecific monoclonal antibody mimicking the cofactor function of activated factor (F)VIII. It indicated for routine prophylaxis bleeding episodes in persons with haemophilia A (PwHA) with/without FVIII inhibitors.
OBJECTIVES: Rifampin is a potent inducer of the cytochrome P450 3A4 isoenzyme (CYP3A4) that metabolizes most protease inhibitor (PI) antiretrovirals. This study was designed to evaluate steady-state pharmacokinetics and tolerability coadministration PIs saquinavir ritonavir (a CYP3A4 used as pharmacoenhancer other PIs) rifampin when coadministered in healthy HIV-negative volunteers. METHODS: In an open-label, randomized, one sequence, two-period crossover involving 28 volunteers, arm 1...
Inclacumab, a novel monoclonal antibody against P-selectin in development for the treatment and prevention of atherosclerotic cardiovascular diseases, was administered an ascending single-dose study as intravenous infusion to evaluate safety, pharmacokinetics, pharmacodynamics. Fifty-six healthy subjects were enrolled this randomized, double-blind placebo-controlled study. Each dose level (0.03–20 mg/kg) investigated separate groups 8 (6 on inclacumab, 2 placebo). Platelet–leukocyte...
Aims To evaluate the pharmacodynamics, pharmacokinetics and safety of single subcutaneous (s.c.) injection ascending doses RG 7697, a dual glucose‐dependent insulinotropic polypeptide/glucagon‐like peptide‐1 agonist, in healthy subjects. Methods A total 51 volunteers were enrolled this double‐blind, placebo‐controlled study investigating 7697 ranging from 0.03 to 5 mg. Adverse events ( AE s) monitored drug concentrations, fasting glycaemic variables, vital signs, ECG , antibody formation...
Emicizumab is a bispecific monoclonal antibody developed for routine prophylaxis of bleeding in people with hemophilia A (PwHA). This work characterizes the pharmacokinetics emicizumab adult and pediatric PwHA, identifies factors contributing to its between-person variabilities, compares following different dosing regimens, makes descriptive assessment exposure–bleeding events relationship. population pharmacokinetic model was developed, using database 389 PwHA from five clinical studies....
Summary Aim The oral MDM2 antagonist idasanutlin inhibits the p53-MDM2 interaction, enabling p53 activation, tumor growth inhibition, and increased survival in xenograft models. Methods We conducted a Phase I study of (microprecipitate bulk powder formulation) to determine maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics, food effect, clinical activity patients with advanced malignancies. Schedules investigated were once weekly for 3 weeks (QW × 3), daily days (QD or...