Clinical Trials
414
17 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1884
Active, not recruiting
7
1.7%
Completed
219
52.9%
Enrolling By Invitation
1
0.2%
No Longer Available
1
0.2%
Not yet recruiting
9
2.2%
Recruiting
64
15.5%
Suspended
2
0.5%
Terminated
61
14.7%
Unknown
2
0.5%
Withdrawn
48
11.6%
No approval data available
- Anteris Technologies has secured CMS reimbursement eligibility for its PARADIGM Trial under the TAVR National Coverage Determination, facilitating U.S. site activation for the pivotal study. - The first U.S. patients have been successfully enrolled and treated in the PARADIGM Trial at Montefiore Medical Center, marking a significant milestone for the global study. - The PARADIGM Trial will evaluate the DurAVR® THV, the first biomimetic transcatheter heart valve, against commercially available TAVRs in approximately 1,000 patients with severe calcific aortic stenosis. - The study aims to assess non-inferiority on a primary composite endpoint of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure.
- Real-world registry data from over 1,000 patients shows the Evoque transcatheter tricuspid valve replacement system achieved a 30-day mortality rate of 3.1% with 98.4% device implant success. - Extended TRILUMINATE trial data from 847 patients demonstrates TriClip edge-to-edge repair maintains excellent safety with 0.5% all-cause mortality and significant quality-of-life improvements. - Both tricuspid valve intervention technologies show improved safety profiles compared to their pivotal trials, with reduced bleeding rates and maintained efficacy in broader patient populations. - Long-term follow-up data remains critical to fully establish the clinical value of these interventions, as neither has yet demonstrated reduction in hard endpoints like heart failure hospitalizations.
- Ursodeoxycholic acid (UDCA), while groundbreaking, leaves up to 40% of Primary Biliary Cholangitis patients with inadequate response, highlighting the need for additional treatment options. - Recent accelerated approvals of PPAR agonists seladelpar and elafibranor offer new hope, with seladelpar showing the first clinically meaningful improvements in pruritus symptoms. - Real-world effectiveness and safety profiles of these new treatments remain to be established, as rare but serious side effects typically only emerge with broader clinical use.
- Hoth Therapeutics has received IRB approval from Montefiore Medical Center and Dana-Farber Cancer Institute for its Phase 2a trial of HT-001. - The Phase 2a trial will assess the efficacy, safety, and tolerability of topical HT-001 for skin toxicities related to EGFR inhibitor treatments. - This First-in-Human trial aims to provide a new therapeutic option for cancer patients suffering from EGFRi-associated skin toxicities. - Hoth Therapeutics reports a strong cash position with over $9 million and no planned capital raise for the remainder of 2024.
- A multicenter real-world study of 110 patients treated with teclistamab demonstrated a 62% overall response rate and 51% very good partial response rate, comparable to the pivotal MajesTEC-1 trial despite treating a more heavily pretreated population. - The incidence of severe cytokine release syndrome and neurotoxicity was substantially higher in real-world practice (3.6% and 4.5% respectively) compared to clinical trials (0.6% each), likely due to higher disease burden in routine practice. - Primary intravenous immunoglobulin prophylaxis significantly reduced infection rates by approximately 70%, with patients receiving IVIG showing lower cumulative incidence of grade 3 or higher infections compared to those without prophylaxis. - Analysis of FDA adverse event data across BCMA-targeted therapies revealed teclistamab had the highest rates of life-threatening events and death, with infections being the predominant cause of non-relapse mortality.
