AnalytischDenker schreef op 11 maart 2021 14:38:
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Mooi, we kunnen dus in ieder geval concluderen dat er in aanstaande juni twee voor Pharming relevante studies (Covid en APDS) voor afronding staan gepland !Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open-label, parallel-group, controlled, multi-center clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).
Actual Study Start Date : August 6, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021
clinicaltrials.gov/ct2/show/NCT044146... Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Part I of the study was a non-randomized, open-label, within-patient up-titration study.
Part II is a randomized, subject, investigator and sponsor-blinded, placebo-controlled, fixed dose study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Part I was a non-randomized, open-label study Part II is a randomized subject, investigator and sponsor-blinded, placebo controlled study
Primary Purpose: Treatment
Official Title: An Open-label, Non-randomized, Within-patient Dose-finding Study Followed by a Randomized, Subject, Investigator and Sponsor-blinded Placebo Controlled Study to Assess the Efficacy and Safety of CDZ173 in Patients With APDS/PASLI
Actual Study Start Date : August 24, 2015
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
clinicaltrials.gov/ct2/show/NCT024351...