Offene Studien

AL Amyloidose

CAELUM Cardiac Amyloid Reaching for Extended Survival

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis
ClinicalTrials.gov Identifier:    NCT04512235 https://clinicaltrials.gov/ct2/show/NCT04512235
Studienzentren in Deutschland: Berlin, Düsseldorf, Essen, Hamburg, Heidelberg, Münster, Würzburg.

 

CAELUM Cardiac Amyloid Reaching for Extended Survival

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis
ClinicalTrials.gov Identifier: NCT04504825 https://clinicaltrials.gov/ct2/show/NCT04504825
Studienzentren in Deutschland: Berlin, Düsseldorf, Essen, Hamburg, Heidelberg, Münster, Würzburg.

 

CLINICAL RESEARCH PROTOCOL

Study Title: A Phase 3, Randomized, Multicenter, Double-Blind,
Placebo-Controlled, Efficacy and Safety Study of
Birtamimab Plus Standard of Care vs. Placebo Plus
Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis
ClinicalTrials.gov Identifier: NCT04973137; https://clinicaltrials.gov/ct2/show/NCT04973137
Studienzentren in Deutschland: Heidelberg

Transthyretin-Amyloid Neuropathie

Neuro-TTRansform (ION 682884 CS3)

A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy 2019-001698-10 ( EudraCT Number )
ClinicalTrials.gov Identifier: NCT04136184 https://clinicaltrials.gov/ct2/show/NCT04136184
Studienzentren in Deutschland: Essen, Heidelberg, Würzburg, Münster.

Transthyretin-Amyloid Kardiopathie

NI-006

A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy Followed by an Open-Label Extension.
2019-001932-80 ( EudraCT Number )
ClinicalTrials.gov Identifier:    NCT04360434 https://clinicaltrials.gov/ct2/show/NCT04360434
Studienzentren in Deutschland: Heidelberg.

HELIOS-B

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
2019-003153-28 ( EudraCT Number )
ClinicalTrials.gov Identifier: NCT04153149 https://clinicaltrials.gov/ct2/show/NCT04153149
Studienzentren in Deutschland: Essen, Göttingen, Heidelberg, Leipzig, Würzburg.

CARDIO-TTRansform

A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM).
2019-002835-27 ( EudraCT Number )
ClinicalTrials.gov Identifier: NCT04136171 https://clinicaltrials.gov/ct2/show/NCT04136171