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0 Diseases |  |
5 Trials |
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5 Trials |  |
56 News |  |
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Enrollment change: Protect-NOW: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients (clinicaltrials.gov) - Nov 2, 2023
P=N/A, N=200, Recruiting, Sponsor: Octapharma
N=140 --> 200
- | Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Observational data, Journal, Real-world evidence, Real-world: Design of a Real-World Observational Study in Previously Untreated and Minimally Treated Hemophilia A Patients: Protect-NOW. (Pubmed Central) - May 14, 2023
P=N/A
The secondary objectives are to assess utilization patterns (including dosage and frequency of administration) and the effectiveness in surgical prophylaxis. Conclusions ?The Protect-NOW study will provide information on the treatment of PUPs and MTPs in routine clinical practice, which will help guide clinical decision making for treating these patients in the future.
- ANALYSIS OF FACTOR VIII LEVELS IN HAEMOPHILIA A TREATED PATIENTS - PRELIMINARY RESULTS OF PHARMACOKINETIC STUDY () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_390;
Our study results demonstrated that in EHL treated patients FVIII levels are higher at particular time points when comparing to SHL-products. In future perspective, implementing available tools like WAPPS-Hemo (Web Accessible Population Pharmacokinetics Service
- Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
A snapshot analysis of a prospective, non-interventional study to evaluate real-life prophylactic treatment schedules of factor VIII concentrates (#153) (foyer) - Feb 8, 2023 - Abstract #GTH2023GTH_388;
No inhibitor formation or any other adverse drug reactions were observed. Conclusion This snapshot analysis with a long observation time of a median of 31.5 months delivered important data on the ABR in real-life treatment of haemophilia A. It further confirms the outstanding tolerability and efficacy of the concentrates investigated.
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Trial completion date, Trial primary completion date: Protect-NOW: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients (clinicaltrials.gov) - Jul 8, 2022
P=N/A, N=140, Recruiting, Sponsor: Octapharma
Conclusion This snapshot analysis with a long observation time of a median of 31.5 months delivered important data on the ABR in real-life treatment of haemophilia A. It further confirms the outstanding tolerability and efficacy of the concentrates investigated. Trial completion date: Jun 2023 --> Jun 2030 | Trial primary completion date: Jun 2023 --> Jun 2030
- | Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Journal: Immune Tolerance Induction (ITI) with a pdFVIII/VWF Concentrate (octanate) in 100 Patients in the Observational ITI (ObsITI) Study. (Pubmed Central) - Jun 22, 2022
PS and CS were achieved in a median of 5.55 and 11.25 months, respectively. Conclusions ITI with pdFVIII/VWF led to rapid eradication of FVIII inhibitors, normalization of FVIII pharmacokinetics in the majority of patients, and a significant reduction in bleeding rates.
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
Practical utilisation of Octapharma FVIII concentrates in previously untreated and minimally treated haemophilia A patients entering routine clinical treatment – The Protect-NOW Study (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_2182;
P=N/A
Recruitment is ongoing, and additional sites are being initiated. Conclusion(s): Protect-NOW is collecting real-world data on the effectiveness and safety of Octapharma FVIII products in routine clinical practice in PUPs and MTPs.
- Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Dose optimisation in children with severe haemophilia A on long-term octanate® prophylaxis (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1143;
The estimated time to 1% FVIII activity for children on a 72-h dosing interval was 78 h in those with no previous BEs (Group 1) and 70 h in those with previous BEs (Group 2). For patients on a 96-h dosing interval, the values were 116 h in children without previous BEs (Group 3) and 111 h in those with previous BEs (Group 4).
- | Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Journal: Evaluation of the digestion and transport profiles and potential immunocompetence of puerarin and its acylated derivatives. (Pubmed Central) - Nov 25, 2021
The apparent permeability coefficients of puerarin, puerarin acetate, puerarin propanoate, puerarin butyrate, puerarin hexanoate, puerarin octanate and puerarin laurate were 1.62 ± 0.09, 1.70 ± 0.15, 1.89 ± 0.19, 1.86 ± 0.18, 2.29 ± 0.12, 4.06 ± 1.01 and 2.32 ± 0.88 × 10-6 cm s-1, respectively, in Caco-2 cell monolayers...These findings suggested that a better absorption could be predicted after oral intake using PAES. Meanwhile, the concentration of esters and their metabolites (puerarin) found in the digestion and transport profiles directly affected their potential immunocompetence.
- || Haemoctin (human plasma derived coagulation factor VIII) / ADMA Biologics, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
El mejor factor es el que llega a tu vena amigo. Acá solo plasmarico de Octanate y de Haemoctin para la Hemofilia A. (Twitter) - Nov 2, 2021
- Hemlibra (emicizumab-kxwh) / Roche
A patient with FVIII inhibitors on emicizumab prophylaxis switching to immune tolerance induction laboratory issues (RIALTO) - Oct 24, 2021 - Abstract #BIC2021BIC_65;
Residual emicizumab activity after discontinuation needs to be taken into consideration when performing clot-based coagulation assays in further follow-up of patients. Regarding inhibitor testing, unlike clotting assay, both chromogenic methods enabled reliable quantification.
- || Clinical, Journal: Design of an international investigator-initiated study on MOdern Treatment of Inhibitor-positiVe pATiEnts with haemophilia A (MOTIVATE). (Pubmed Central) - Oct 1, 2021
P=N/A, P4
It is planned to enrol 120 patients who will be followed for up to 5 years. Optional sub-studies will explore factors that may influence ITI results as well as the impact of different treatment approaches on important aspects of patient health, including joint and bone health and the risk of thrombotic events.
- Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
[VIRTUAL] PRactical Utilisation of Octapharma FVIII Concentrates in Previously Untreated and Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment with Nuwiq®, octanate® or wilate® – The Protect-NOW Study (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_987;
Results : As of March 2021, 37 patients have been enrolled in the study from 13 sites in Belarus, Canada, France, Germany, Italy, Lithuania, Spain and the United Kingdom, with additional sites to be initiated. Conclusions : Protect-NOW is collecting clinically relevant information on the outcomes of PUPs and MTPs treated with Octapharma‘s FVIII products in a real-world setting.
- || Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Clinical, Review, Journal: Personalised Prophylaxis in a Child with Haemophilia A and Type 1 Diabetes. (Pubmed Central) - Jun 3, 2021
rFVIII was well tolerated, with no treatment-related adverse events observed. This case illustrates the importance of treatment personalisation for young patients and their families managing concomitant diseases.
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Trial completion date, Trial primary completion date: Protect-NOW: Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients (clinicaltrials.gov) - Jan 25, 2021
P=N/A, N=140, Recruiting, Sponsor: Octapharma
This case illustrates the importance of treatment personalisation for young patients and their families managing concomitant diseases. Trial completion date: Jun 2022 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023
- [VIRTUAL] PHARMACOKINETIC DIFFERENCES IN HEMOPHILIA A BASED ON FVIII PRODUCT AND ON ASSAY TYPE () - Jan 8, 2021 - Abstract #EAHAD2021EAHAD_16;
It is still uncertain whether “Elocta” correlates with higher FVIII levels on CSA and if this fact was relevant for our statistically significant results in t1/2 of EHL in CSA. Interestingly, plasma‐derived product presented higher t1/2 than recombinant products, even though n.s. Although the number of studied patients was low to draft definitive conclusions, making comparison analysis between products more difficult, we observed minimal FVIII measurement discrepancies among OSA and CSA.
- | Enrollment change, Trial withdrawal: RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - Dec 17, 2020
P=N/A, N=0, Withdrawn, Sponsor: City of Hope Medical Center
Interestingly, plasma‐derived product presented higher t1/2 than recombinant products, even though n.s. Although the number of studied patients was low to draft definitive conclusions, making comparison analysis between products more difficult, we observed minimal FVIII measurement discrepancies among OSA and CSA. N=148 --> 0 | Active, not recruiting --> Withdrawn
- || Trial completion, Trial completion date, Trial primary completion date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Dec 17, 2020
P=N/A, N=3, Completed, Sponsor: City of Hope Medical Center
N=148 --> 0 | Active, not recruiting --> Withdrawn Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Oct 2020 | Trial primary completion date: Jun 2020 --> Oct 2020
- ||| Enrollment open, Trial initiation date: MOTIVATE: Treatment of Hemophilia A Patients With FVIII Inhibitors (clinicaltrials.gov) - Jun 1, 2020
P=N/A, N=120, Recruiting, Sponsor: Emory University
Active, not recruiting --> Completed | Trial completion date: Jun 2020 --> Oct 2020 | Trial primary completion date: Jun 2020 --> Oct 2020 Not yet recruiting --> Recruiting | Initiation date: Jun 2020 --> Mar 2020
- [VIRTUAL] MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A - MOTIVATE (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_1010;
MOTIVATE will collect real-world clinical experience on current approaches for the management of haemophilia A with inhibitors. The results will help facilitate discussions on the optimal treatment approach for people with haemophilia A and inhibitors.
- Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
[VIRTUAL] Immune Tolerance Induction with Octanate® in Patients with Haemophilia A and Inhibitors: An Ongoing Case Series from a Malaysian Centre (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_1009;
These data indicate a high success rate and rapid achievement of negative inhibitor titres with octanate® in patients with severe haemophilia A and inhibitors. Moderate dose regimens for ITI can successfully eradicate inhibitors and make ITI feasible in countries with limited resources.
- Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
[VIRTUAL] Immune Tolerance Induction (ITI) with a Single Factor VIII/von Willebrand Factor Concentrate in Haemophilia A Patients with Inhibitors - Update from the ObsITI Study (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_970;
P=N/A
Moderate dose regimens for ITI can successfully eradicate inhibitors and make ITI feasible in countries with limited resources. ITI with octanate® led to a rapid and safe eradication of FVIII inhibitors and normalisation of FVIII pharmacokinetics in largely poor prognosis patients.
- || Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Clinical, Review, Journal: octanate: over 20 years of clinical experience in overcoming challenges in haemophilia A treatment. (Pubmed Central) - Apr 30, 2020
No relapses were observed. Here we present an overview of the clinical data with octanate® that support its use in a range of patient populations and clinical indications.
- Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Immune tolerance induction (ITI) with a single factor VIII/von willebrand factor concentrate in haemophilia A patients with inhibitors – Data from the obsiti study () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_329;
P=N/A
Here we present an overview of the clinical data with octanate® that support its use in a range of patient populations and clinical indications. ITI with octanate® was successful in a large proportion of patients and led to rapid, sustained eradication of FVIII inhibitors.
- Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Impact of factor VIII gene (F8) mutation on immune tolerance induction (ITI) outcomes in haemophilia A patients with inhibitors in the ObsITI study () - Feb 4, 2020 - Abstract #EAHAD2020EAHAD_312;
P=N/A
Amongst patients treated with octanate® for ITI in the ongoing ObsITI study, the likelihood of ITI success and time to achieve success appeared to be related to the type of F8 gene mutation. Patients with large deletions appeared less likely to achieve ITI success than patients with other mutations, and the time to achieve success was longer.
- |||| New P4 trial: An international investigator trial to capture different approaches in the treatment of Hemophilia A Patients With FVIII Inhibitors (EUDRACT) - Jan 28, 2020
P4, N=120, , Sponsor: HZRM
- NovoEight (turoctocog alfa) / Novo Nordisk
VWf containing therapeutic concentrates induce FXII activation, leading to kallikrein activation and bradykinin formation in vitro (Lloyd) - Dec 17, 2019 - Abstract #GTH2020GTH_28;
Further research aims to analyse the role of vWF FXII interaction in more detail. Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany
- || Trial initiation date: MOTIVATE: Treatment of Hemophilia A Patients With FVIII Inhibitors (clinicaltrials.gov) - Dec 12, 2019
P=N/A, N=120, Not yet recruiting, Sponsor: Emory University
Part of the work was supported by a grant of Bayer Vital GmbH, 51368 Leverkusen, Germany Initiation date: Nov 2019 --> Feb 2020
- | New trial: MOTIVATE: Treatment of Hemophilia A Patients With FVIII Inhibitors (clinicaltrials.gov) - Jul 16, 2019
P, N=120, Not yet recruiting, Sponsor: Emory University
- | Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Journal: Effect of Silane Treatment on Mechanical Properties of Polyurethane/Mesoscopic Fly Ash Composites. (Pubmed Central) - Apr 27, 2019
In view of the accidents such as rock mass breakage, roof fall and coal slide in coal mines, polyurethane/mesoscopic fly ash (PU/MFA) reinforcement materials were produced from polymethylene polyphenylene isocyanate (PAPI), the polyether polyol, flame retardant, and MFA using stannous octanate as a catalyst...The results show that the compression property, fracture toughness, maximum flexural strength, and bond strength of PU/MFA composites increase by 21.6%, 10.1%, 8.8%, and 19.3%, respectively, compared with the values before the modification. Furthermore, the analyses of scanning electron microscope and dynamic mechanics suggest that the coupling agent GPTMS can successfully improve the mechanical properties of PU/MFA composites because it eliminates the stress concentration and exerts a positive effect on the crosslink density and hardness of PU/MFA composites.
- | New P4 trial: Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients. Implementatie van farmacokinetisch gestuurd doseren van profylaxe bij hemofilie patienten. (EUDRACT) - Dec 21, 2018
P4, N=50, , Sponsor: Erasmus University Medical Center
- || Trial initiation date: RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - Apr 11, 2017
P=N/A, N=148, Active, not recruiting, Sponsor: City of Hope Medical Center
Furthermore, the analyses of scanning electron microscope and dynamic mechanics suggest that the coupling agent GPTMS can successfully improve the mechanical properties of PU/MFA composites because it eliminates the stress concentration and exerts a positive effect on the crosslink density and hardness of PU/MFA composites. Initiation date: Jun 2009 --> Sep 2009
- Trial initiation date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Apr 11, 2017
P=N/A, N=3, Active, not recruiting, Sponsor: City of Hope Medical Center
Initiation date: Jun 2009 --> Sep 2009 Initiation date: Jun 2009 --> Sep 2009
- Enrollment closed, Trial primary completion date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Apr 1, 2015
P=N/A, N=3, Active, not recruiting, Sponsor: City of Hope Medical Center
Initiation date: Jun 2009 --> Sep 2009 Completed --> Active, not recruiting | Trial primary completion date: Feb 2015 --> Jun 2020
- Trial completion, Enrollment change, Trial primary completion date: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - Mar 5, 2015
P=N/A, N=3, Completed, Sponsor: City of Hope Medical Center
Completed --> Active, not recruiting | Trial primary completion date: Feb 2015 --> Jun 2020 Active, not recruiting --> Completed | N=50 --> 3 | Trial primary completion date: Jun 2020 --> Feb 2015
- Enrollment closed: RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - May 4, 2014
P=N/A, N=50, Active, not recruiting, Sponsor: City of Hope Medical Center
Active, not recruiting --> Completed | N=50 --> 3 | Trial primary completion date: Jun 2020 --> Feb 2015 Recruiting --> Active, not recruiting
- || Enrollment closed: RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - May 16, 2013
P=N/A, N=148, Active, not recruiting, Sponsor: City of Hope Medical Center
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting