Clinical trials: Immune-related Adverse Events
Drug/Agent Toxicity by Tissue/Organ, Lymphoma
Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
RATIONALE: Denileukin diftitox may be able to deliver cancer-killing substances directly to T-cell lymphoma cells. Dexamethasone may decrease the side effects of denileukin diftitox.
- Trial name
- NCT00006345
- Testing
- denileukin diftitox, dexamethasone
- Where
- 11 sites in United States
- Sponsor
- Ligand Pharmaceuticals
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Cancer
A Study of ApricityRx™ for Management of IR-AEs in Patients on Immuno-Oncology Therapy
Study of ApricityRx™ for Management of IR-AEs for patients on I-O therapy. Patients currently receiving immunotherapy will be asked to consent to participate in ApricityRx software platform mobile telephone application to report…
- Trial name
- NCT04571398
- Testing
- ApricityRx mobile application
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Apricity Health, Inc
Candidiasis, Esophageal, HIV Infections
A Study of the Side Effects of L-743,872 in Men With Candidal Esophagitis
The purpose of this study is to see if it is safe to give L-743,872 to men with candidal esophagitis, an AIDS-related yeast infection in the esophagus.
- Trial name
- NCT00005921
- Testing
- L-743,872
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection
This study will investigate whether the simplified regimen of a once daily fixed dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate [DF]) will be associated with a reduced rate of adverse events, seen…
- Trial name
- NCT00323544
- Testing
- zidovudine and lamivudine (Combivir®), emtricitabine and tenofovir DF
- Where
- United Kingdom
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Acute Lymphoblastic Leukemia, Pediatric, Adverse Drug Event
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia
This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.
- Trial name
- NCT04770922
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Cipherome, Inc.
Aspirin Exacerbated Respiratory Disease (AERD)
Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease
The primary objective of the study is to determine the safety of oral ifetroban compared to placebo as measured by a > 20% decrease in FEV1 compared to baseline following a dose of Investigational Medicinal Product (IMP) (Study…
- Trial name
- NCT02216357
- Testing
- Ifetroban, Oral Capsule
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cumberland Pharmaceuticals
Hypersensitivity Reactions
Post-market Safety Study of LUMISIGHT
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with…
- Trial name
- NCT07572162
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Relapsing-Remitting Multiple Sclerosis (RRMS)
Brimonidine Tartrate for the Treatment of Injection Related Erythema
The primary objective of this study is to evaluate the Injection Related Erythema (IRE) mitigation effect of a single administration of brimonidine tartrate in comparison with a vehicle gel (placebo).
- Trial name
- BRITE (NCT02568111)
- Testing
- peginterferon beta-1a, brimonidine tartrate, Vehicle Gel
- Sponsor
- Biogen
Colitis, Hepatitis
PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.
- Conditions
- Colitis, Hepatitis, Melanoma (Skin Cancer)
- Trial name
- PHOENIX-ECP (NCT07619898)
- Testing
- methoxsalen, Extracorporeal photopheresis (ECP), Vedolizumab
- Volunteers
- 112 people
- Sponsor
- Therakos LLC
Pustular Psoriasis (PP), Generalized Pustular Psoriasis (GPP)
Evaluating Legit.Health Plus Support for Improving Diagnosis of Generalized Pustular Psoriasis and Other Skin Conditions Among Primary Care Physicians and Dermatologists
This study aims to determine if an artificial intelligence (AI) medical device can help healthcare professionals more accurately diagnose rare and complex skin conditions.
- Conditions
- Pustular Psoriasis (PP), Generalized Pustular Psoriasis (GPP), Eczema Atopic Dermatitis, Acute Generalized Exanthematous Pustulosis
- Trial name
- LegitHealth BI (NCT07428915)
- Testing
- AI-based medical device for aided diagnosis in Dermatology
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- AI Labs Group S.L
Melanoma
Retrospective Assessment of AE-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma
This was a retrospective cohort study using Truven Health Analytics' MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefit administrative claims databases.
- Trial name
- NCT05874817
- Where
- United States
- Volunteers
- 17,517 people
- Sponsor
- Novartis Pharmaceuticals
Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic…
- Trial name
- NCT05137847
- Testing
- Remitoro
- Where
- 3 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Eisai Inc.
Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens.
- Conditions
- Stevens-Johnson Syndrome, Graft Versus Host Disease in Eye, Sjogren's Syndrome, Dry Eye
- Trial name
- NCT04313725
- Testing
- Tangible Boost
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Tangible Science
Multiple Sclerosis, Relapsing-Remitting
A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis
The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms (FLS) as reported by the relapsing-remitting…
- Trial name
- PERFECT (NCT03347370)
- Testing
- SC Peginterferon beta-1a, SC interferon beta-1a, SC interferon beta-1b
- Where
- Germany
- Volunteers
- 626 people
- Sponsor
- Biogen
HIV Infections
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables.
- Trial name
- NCT06970223
- Testing
- Cabotegravir long-acting, Lenacapavir long-acting
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Cancer, Immunotherapy
A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.
The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs)…
- Conditions
- Cancer, Immunotherapy, PD-1, PD-L1
- Trial name
- PROWES (NCT06635954)
- Where
- 3 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Oxford Biodynamics Inc.
Asthma, Aspirin-Induced
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD).
- Trial name
- NCT03028350
- Testing
- Ifetroban Oral Capsule
- Where
- 16 sites in United States
- Volunteers
- 54 people
- Sponsor
- Cumberland Pharmaceuticals
Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
Patients diagnosed with Stevens-Johnson syndrome and Toxic Epidermal Necrolysis were confirmed based on the investigators national diagnostic criteria.
- Trial name
- NCT01696500
- Testing
- Intravenous immunoglobulin
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Nihon Pharmaceutical Co., Ltd
CVI - Common Variable Immunodeficiency
A Study to Evaluate the Benefit of RUCONEST® in Subjects Who Experience ADRs Related to IVIG Infusions
Patients receiving intravenous immunoglobulin (IVIG) therapy for primary immunodeficiency and neurologic conditions may experience adverse drug reactions (ADRs). The mechanism of the ADR is unknown.
- Trial name
- NCT03576469
- Testing
- C1-esterase inhibitor [recombinant] (C1-INH-R)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- IMMUNOe Research Centers