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Clinical Trial News

NIH Launches Influenza Human Challenge Study to Advance Vaccine Development

  • The National Institute of Allergy and Infectious Diseases (NIAID) has initiated a clinical trial where healthy adults will be deliberately infected with influenza virus under controlled conditions at four research sites across the US.
  • The study aims to assess how pre-existing influenza antibodies affect the timing, magnitude, and duration of flu symptoms, with up to 80 volunteers aged 18-50 participating in the trial.
  • Participants will receive a nasal spray containing the InfluenzaA/Bethesda/MM2/H1N1 strain and remain under observation for at least seven days, with preliminary results expected by May 2020.

H1N1v Virus Challenge Study in Healthy Subjects

NCT04044352CompletedPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)
Posted 10/22/2019

The TREATT Trial: Evaluating Tranexamic Acid in Haematological Malignancies

The TREATT trial investigates the use of tranexamic acid (TXA) in patients with haematological malignancies to reduce bleeding and the need for platelet transfusions. This multinational, randomized, double-blind, placebo-controlled trial aims to assess the effectiveness and safety of TXA during periods of severe thrombocytopenia.

Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study

NCT02650791CompletedPhase 3
Ottawa Hospital Research Institute
Posted 10/1/2016

American Trial Using Tranexamic Acid in Thrombocytopenia

NCT02578901CompletedPhase 3
University of Washington
Posted 6/1/2016

TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

NCT03136445CompletedPhase 3
NHS Blood and Transplant
Posted 6/1/2015

Final Analysis from RESONATE: Up to Six Years of Follow-up on Ibrutinib vs Ofatumumab in CLL

The final analysis of the RESONATE study, with up to six years of follow-up, highlights the efficacy and safety of ibrutinib compared to ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ibrutinib demonstrated significantly longer progression-free survival (PFS) and overall survival (OS) benefits, especially in high-risk patients. The study also noted the long-term tolerability of ibrutinib, with a decrease in adverse events over time.

MRD Negativity as a Surrogate Endpoint for PFS in Newly Diagnosed Multiple Myeloma

  • Meta-analysis of six randomized trials with 3,283 NDMM patients supports MRD negativity as a surrogate endpoint for progression-free survival (PFS).
  • Treatment effect on MRD negativity strongly correlates with the treatment effect on PFS, indicating its potential to predict clinical benefit.
  • The study suggests MRD status can be used in clinical trials for NDMM, potentially accelerating drug development and approval processes.
  • These findings align with FDA workshop guidelines, supporting MRD negativity as a Level 3 surrogate endpoint for PFS in NDMM.

A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma

NCT00531453CompletedPhase 2
Millennium Pharmaceuticals, Inc.
Posted 10/1/2007

Focused Ultrasound Successfully Opens Blood-Brain Barrier in ALS Patients: Groundbreaking Trial Results

  • Sunnybrook researchers have demonstrated the safety of using focused ultrasound to temporarily open the blood-brain barrier in ALS patients, marking a world-first clinical achievement published in Nature Communications.
  • The groundbreaking technique successfully targeted the motor cortex—a brain region critically affected by ALS—potentially creating a non-invasive pathway for delivering therapeutics directly to affected neural tissues.
  • Following these promising Phase I results, researchers are preparing to advance to Phase II trials that will involve the delivery of actual ALS therapeutics through the temporarily opened blood-brain barrier.

Small Clinical Trial Shows Drug Cocktail Reverses Biological Age by 2.5 Years

  • A small clinical trial of nine men aged 51-65 demonstrated that a combination of growth hormone and two diabetes medications reversed biological age by an average of 2.5 years as measured by epigenetic clocks.
  • The study, led by Gregory Fahy at Intervene Immune and analyzed by UCLA geneticist Steve Horvath, originally aimed to restore thymus gland tissue but unexpectedly showed broader anti-aging effects.
  • Participants showed rejuvenated immune systems with improved blood cell counts and thymus tissue regeneration, though researchers emphasize the preliminary nature of results from this small, uncontrolled study.
  • The biological age reversal effects accelerated after nine months of treatment and remained largely intact six months after the trial ended, suggesting potential durability of the intervention.

Clinical Trial Retention Crisis: 30% Dropout Rate Costs Industry Billions and Delays Drug Development

  • Global clinical trials face a critical challenge with 30% average dropout rates, while less than 5% of eligible participants initially enroll, significantly impacting drug development timelines and costs.
  • Clinical trial complexity has increased over the past decade, with more frequent visits and data collection requirements, while rare disease focus has narrowed the eligible patient pool.
  • Removing logistical barriers and providing comprehensive patient support services could significantly improve retention rates, according to Greenphire CEO Jim Murphy.

Minimal Residual Disease Status Validated as Surrogate Endpoint for Progression-Free Survival in Newly Diagnosed Multiple Myeloma

  • Meta-analysis of six randomized studies confirms minimal residual disease (MRD) status as a surrogate endpoint for progression-free survival (PFS) in newly diagnosed multiple myeloma (NDMM).
  • The treatment effect on MRD-negative response strongly correlated with the hazard ratio for PFS, demonstrating a high coefficient of determination of 0.97.
  • Findings support the use of MRD status to accelerate drug development by providing a faster prediction of survival outcomes in NDMM patients.
  • The study included 3283 patients and 2208 MRD samples, reinforcing the robustness of MRD as a surrogate marker for PFS.

Doxycycline Prophylaxis Shows Promise in Preventing Bacterial STIs Among High-Risk Populations

• Doxycycline prophylaxis demonstrates potential in preventing bacterial sexually transmitted infections (STIs), particularly among gay, bisexual, and other men who have sex with men. • Studies indicate that doxycycline prophylaxis can significantly reduce the incidence of syphilis and chlamydia, but further research is needed to confirm efficacy. • Ongoing studies are exploring optimal doxycycline dosage, regimen, and formulation, as well as long-term safety and the potential for antimicrobial resistance. • Experts emphasize the need for more robust data on community acceptability, behavioral risk compensation, and cost-effectiveness before broad recommendations can be made.

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