- |||||||||| Soliris (eculizumab) / Alexion Pharma
Clinical, Review, Journal: Clinical guides for atypical hemolytic uremic syndrome in Japan. (Pubmed Central) - Mar 23, 2019 Recent clinical and molecular findings have resulted in several proposed classifications and definitions of thrombotic microangiopathy and aHUS. Based on recent advances in this field and the emerging international consensus to exclude secondary TMAs from the definition of aHUS, we have redefined aHUS and proposed diagnostic algorithms, differential diagnosis, and therapeutic strategies for aHUS.
- |||||||||| SB12 (eculizumab biosimilar) / AffaMed Therap, Samsung
Enrollment open: Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects (clinicaltrials.gov) - Nov 20, 2018 P1, N=240, Recruiting, Early initiation of ECU may not alter the disease process enough to restore organ function, but it may prolong survival. Not yet recruiting --> Recruiting
- |||||||||| Soliris (eculizumab) / AstraZeneca
Clinical, Journal: A case of atypical hemolytic uremic syndrome in a second renal transplant. (Pubmed Central) - Oct 31, 2018 Interestingly, he developed early de novo donor specific antibodies (DSA) after the second renal transplant in context of likely recurrent aHUS. Terminal complement inhibition with eculizumab resulted in prompt improvement of renal allograft function.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion date, Trial initiation date, Trial primary completion date: Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation (clinicaltrials.gov) - Oct 22, 2018 P1, N=10, Not yet recruiting, Terminal complement inhibition with eculizumab resulted in prompt improvement of renal allograft function. Trial completion date: Oct 2020 --> Dec 2020 | Initiation date: Aug 2018 --> Nov 2018 | Trial primary completion date: Oct 2019 --> Dec 2019
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion, Enrollment change: Complement Inhibitor Eculizumab in Clinical Islet Transplantation (clinicaltrials.gov) - Oct 4, 2018 P2, N=3, Completed, Trial completion date: Oct 2020 --> Dec 2020 | Initiation date: Aug 2018 --> Nov 2018 | Trial primary completion date: Oct 2019 --> Dec 2019 Recruiting --> Completed | N=10 --> 3
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury (clinicaltrials.gov) - Sep 1, 2018 P2, N=57, Completed, Not yet recruiting --> Recruiting Recruiting --> Completed | N=40 --> 57 | Trial completion date: May 2019 --> Dec 2017 | Trial primary completion date: Mar 2018 --> Apr 2017
- |||||||||| Soliris (eculizumab) / AstraZeneca
Enrollment closed: An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients (clinicaltrials.gov) - Aug 22, 2018 P3, N=119, Active, not recruiting, Recruiting --> Completed | N=40 --> 57 | Trial completion date: May 2019 --> Dec 2017 | Trial primary completion date: Mar 2018 --> Apr 2017 Enrolling by invitation --> Active, not recruiting
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Soliris (eculizumab) / AstraZeneca
Trial completion date, Trial primary completion date: DUET: The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation (clinicaltrials.gov) - Jul 18, 2018 P4, N=20, Enrolling by invitation, Recruiting --> Completed | Trial completion date: Jun 2019 --> Jun 2018 | Trial primary completion date: Jun 2019 --> Jun 2018 Trial completion date: Mar 2018 --> Dec 2019 | Trial primary completion date: Oct 2017 --> Dec 2018
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion date, Trial primary completion date: An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients (clinicaltrials.gov) - Jul 2, 2018 P3, N=132, Enrolling by invitation, Our experience underscores the importance of considering the diagnosis of intestinal TA-TMA in patients with refractory post-transplant diarrhea and GI bleeding, even if all classic features are not present. Trial completion date: Dec 2018 --> Jun 2020 | Trial primary completion date: Dec 2018 --> Jun 2020
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion, Phase classification, Trial completion date, Trial primary completion date: Identification and Treatment of Thrombotic Microangiopathies in Allogeneic Stem Cell Transplants (clinicaltrials.gov) - Mar 30, 2018 P, N=200, Completed, Short-term patient and graft outcomes were worse for those with treated AMR. Recruiting --> Completed | Phase classification: PN/A --> P | Trial completion date: Jun 2017 --> Mar 2018 | Trial primary completion date: Jun 2017 --> Mar 2018
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion date, Trial primary completion date: A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) (clinicaltrials.gov) - Mar 7, 2018 P3, N=132, Active, not recruiting, Recruiting --> Completed | Phase classification: PN/A --> P | Trial completion date: Jun 2017 --> Mar 2018 | Trial primary completion date: Jun 2017 --> Mar 2018 Trial completion date: Dec 2017 --> May 2018 | Trial primary completion date: Dec 2017 --> May 2018
- |||||||||| Soliris (eculizumab) / AstraZeneca
Enrollment change, Trial completion date, Trial termination: Eculizumab for Prevention of Delayed Graft Function (DGF) in Kidney Transplantation (clinicaltrials.gov) - Feb 27, 2018 P2, N=21, Terminated, Trial completion date: Dec 2017 --> May 2018 | Trial primary completion date: Dec 2017 --> May 2018 N=48 --> 21 | Active, not recruiting --> Terminated | Trial completion date: Dec 2018 --> Dec 2017; Based on results from Alexion PROTECT DGF study
- |||||||||| Soliris (eculizumab) / Alexion Pharma
Journal: Terminal complement blockade after HSCT is safe without meningococcal vaccination. (Pubmed Central) - Jan 31, 2018 The incidence of bacterial and fungal blood stream infections were similar in patients treated with eculizumab (n=30) as compared to those with HSCT-associated TMA who did not receive any complement blocking therapy (n=39). Our data indicate that terminal complement blockade in the early post-transplant period can be performed without meningococcal vaccination while using appropriate antimicrobial prophylaxis until complement function is restored after therapy completion.
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial completion: EAGLE: Eculizumab in Primary MPGN (clinicaltrials.gov) - Jan 17, 2018 P2, N=10, Completed, The possible effect of complement blockade is discussed. Active, not recruiting --> Completed
- |||||||||| Soliris (eculizumab) / AstraZeneca
Biomarker, Enrollment closed: Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment (clinicaltrials.gov) - Nov 7, 2017 P4, N=330, Active, not recruiting, Recruiting --> Active, not recruiting Enrolling by invitation --> Active, not recruiting
- |||||||||| Soliris (eculizumab) / AstraZeneca
Trial primary completion date: EAGLE: Eculizumab in Primary MPGN (clinicaltrials.gov) - Oct 19, 2017 P2, N=10, Active, not recruiting, Trial primary completion date: Jun 2018 --> Jun 2019 Trial primary completion date: Sep 2017 --> Dec 2017
- |||||||||| Soliris (eculizumab) / AstraZeneca, Ultomiris IV (ravulizumab-cwvz IV) / AstraZeneca
Enrollment closed: ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Na (clinicaltrials.gov) - Jul 31, 2017 P3, N=246, Active, not recruiting, Recruiting --> Completed | N=15 --> 10 | Trial primary completion date: Dec 2017 --> Aug 2017 Recruiting --> Active, not recruiting
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