IPERCOLESTEROLEMIA FAMILIARE PDF

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Print Download. Examples: Cancer AND drug name. Pneumonia AND sponsor name. How to search [pdf]. For these items you should use the filters and not add them to your search terms in the text field. Print Download Summary.

Review by the Competent Authority or Ethics Committee in the country concerned. As of 1. EU Clinical Trials Register. Search tools. Select Date Range: to. Select Rare Disease:. IMP with orphan designation in the indication. Orphan Designation Number:. Results Status: Trials with results Trials without results.

Clear advanced search filters. Date on which this record was first entered in the EudraCT database:. View results. Title of the trial for lay people, in easily understood, i.

A clinical study to assess the safety and efficacy of AMG on low density cholesterol in subjects with homozygous familial hypercholesterolemia or PCSK9 mutations.

The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product. Combination product that includes a device, but does not involve an Advanced Therapy.

Homozygous Familial Hypercholesterolemia. Hypercholesterolemia high cholesterol , familial. To characterize the safety and tolerability of long-term administration of AMG among patients with severe familial hypercholesterolemia.

Subjects participating in the apheresis substudy will complete a separate informed consent. The apheresis substudy will provide additional information for treatment with AMG in this grevious patient population. Approximately 10 subjects will participate in the substudy. Subjects in the substudy will be required to visit the study site for additional blood draws and assessments. Fasting lipids, PCSK9, PK, vital signs, concomitant medication changes, and adverse events will be evaluated and will include a total of 17 additional visits during the study.

I soggetti che accetteranno di partecipare al sottostudio di aferesi forniranno un consenso informato separato. Si prevede che circa 10 soggetti parteciperanno al sottostudio.

Nello specifico: test lipidico a digiuno, PCSK9, PK, segni vitali, cambiamenti nei farmaci concomitanti, e valutazione degli eventi avversi, per un totale di 17 visite addizionali nel corso dello studio. I soggetti con aferesi dovranno avere un programma di aferesi allineato con il dosaggio Q2W di AMG Subjects will be eligible for the study if they: - Completed study or another qualifying Amgen parent protocol, did not experience a treatment related serious adverse event that led to IP discontinuation, and are still taking investigational product at the end of the study, or - Have severe familial hypercholesterolemia due to genetic causes beyond LDL receptor mutations , such as PCSK9 gain of function mutations, as evidenced by genetic or functional evidence and have not participated in a parent protocol.

Non-parent study subjects that meet inclusion criteria 4. Aver completato lo studio o un protocollo di studio originario qualificante su AMG , non aver riportato eventi avversi seri correlati al trattamento che abbiano portato alla sospensione del prodotto sperimentale PS e siano ancora in trattamento con il prodotto sperimentale alla fine di quello studio. Tutti gli altri soggetti: 2. Possono essere arruolati altri soggetti con ipercolesterolemia familiare omozigote che soddisfino i criteri di inclusione ed esclusione dello studio dopo la chiusura dello stesso.

I soggetti con ipercolesterolemia familiare omozigote non eleggibili per un altro studio AMG per esempio soggetti in aferesi possono essere eleggibili alla partecipazione previa approvazione del Medical Monitor Amgen. I soggetti con ipercolesterolemia familiare severa con cause genetiche diverse dalle mutazioni del recettore delle LDL per esempio mutazioni di PCSK9 con guadagno di funzione che non hanno partecipato a uno studio originario su AMG possono essere eleggibili previa approvazione del Medical Monitor di Amgen.

Le donne in premenopausa devono essere disposte ad adottare almeno un metodo contraccettivo di elevata efficacia durante il trattamento e per altre 15 settimane dopo la fine del trattamento. Subject incidence of treatment emergent adverse events. From baseline to week 24 Q4W, at interval visits week 16 and 20 and quaterly after week 24 until EoS. Dal basale alla settimana 24 Q4W, a visite alternate settimana 16 e 20 e trimestrale dopo la settimana 24 fino EoS.

Altra frequenza di somministrazione. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial. The study will continue for 5 years or until AMG becomes commercially available, whichever is earlier. Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.

The plans for treatment or care after the subject has ended participation in the trial are not different from the expected normal treatment of this condition. I piani terapeutici o le cure forniti al soggetto una volta terminata la partecipazione allo studio, non differiscono dal trattamento di routine della patologia.

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Clinical trials

A spiegare questa associazione sono i numerosi fattori di rischio Il trial PolyIran, uno studio a due bracci, pragmatico, randomizzato a cluster, innestato all'interno del Golestan Cohort Study GCS , uno studio di coorte di Fattori di rischio e danno cardiovascolare nel paziente diabetico - Ipertrigliceridemia: rischio vascolare e di pancreatite - La sfida quotidiana per raggiungere il goal di LDL - New mechanisms in atherosclerosis - Lipidi e aterogenesi: non solo colesterolo. Vuoi far parte della nostra grande famiglia per ricevere supporto e condividere la tua esperienza?

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Only comments seeking to improve the quality and accuracy of information on the Orphanet website are accepted. For all other comments, please send your remarks via contact us. Only comments written in English can be processed. An Orphanet summary for this disease is currently under development. However, other data related to the disease are accessible from the Additional Information menu located at the bottom of this page. Additional information. Other search option s Alphabetical list.

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