Clinical trials: Drug Reactions
Tumor Infiltrating Lymphocytes, Safety
A Phase I Study of GC101 TIL in Advanced Solid Tumors
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study.
- Conditions
- Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy
- Trial name
- MIZAR-001 (NCT05417750)
- Testing
- TIL therapy
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Shanghai Juncell Therapeutics
Drug Hypersensitivity
Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase.
- Trial name
- NCT00198458
- Testing
- Vitrase
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
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
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
Injection Site Reaction
Prospective Study to Assess Tissue Responses After Injection With Biostimulatory Products
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints.
- Trial name
- NCT06093815
- Testing
- Injection
- Where
- Spain
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Drug-induced Liver Injury
Rechallenge, Potential Drug Induced Liver Injury (Kaiser)
Drug re-administration or rechallenge should be avoided after drug-induced liver injury (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug and patient subjects.
- Trial name
- NCT01584765
- Testing
- Prescription drugs with known hepatotoxicity
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Drug-Induced Liver Injury
Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury
The purpose of this study is to investigate the safety, effective dosage and treatment of Magnesium Isolycyrrhizinate Injection to cure the acute drug-induced liver injury compared with the Tiopronin Injection.
- Trial name
- NCT02734966
- Testing
- Magnesium Isoglycyrrhizinate Injection 100mg OD, Magnesium Isoglycyrrhizinate Injection 200mg OD, Tiopronin Injection
- Where
- 8 sites in China
- Volunteers
- 174 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Dyskinesia, Medication-induced, Dyskinesia, Drug-Induced
Safety and Tolerability of Single and Repeated Dose of IMM02-KORA in PD-associated Dyskinesia
The goal of this clinical trial is to test Safety and tolerability of single and repeated dose of IMM02-KORA in subjects with PD-associated dyskinesia.
- Trial name
- KORA-LID-1 (NCT07905976)
- Testing
- IMM02-KORA
- Volunteers
- 15 people
- Sponsor
- Immunis, Inc.
Genetics of Drug Metabolism
Utility of PharmacoGenomics for Reducing Adverse Drug Effects
UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency…
- Trial name
- UPGRADE (NCT02081872)
- Where
- 41 sites in United States
- Volunteers
- 279,000 people
- Sponsor
- Companion Dx Reference Lab, LLC
Type 2 Diabetes Mellitus
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period.
- Trial name
- NCT00365781
- Testing
- ISIS 113715
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
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
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.
Adverse Drug Event
NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden
A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.
- Trial name
- NCT04740645
- Testing
- NOCDURNA Cohort, LUTS Cohort
- Where
- 3 sites in Denmark, Germany and 1 more
- Volunteers
- 1,099,551 people
- Sponsor
- Ferring Pharmaceuticals
Parkinson Disease, Dyskinesia, Drug-Induced
Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy
This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind…
- Conditions
- Parkinson Disease, Dyskinesia, Drug-Induced, Dyskinesias
- Trial name
- NCT05116813
- Testing
- Dipraglurant
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Addex Pharma S.A.
Carcinoid Syndrome
Telotristat Etiprate for Carcinoid Syndrome Therapy
The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.
- Trial name
- TELECAST (NCT02063659)
- Testing
- Telotristat etiprate
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 76 people
- Sponsor
- Lexicon Pharmaceuticals
COVID, Drug Effect
Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations
This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance…
- Conditions
- COVID, Drug Effect, Drug Interaction, Adverse Drug Event
- Trial name
- NCT04378881
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Tabula Rasa HealthCare
Cancer, Drug Induced Liver Injury
Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy
Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality.
- Trial name
- NCT05789797
- Testing
- Remaxol
- Where
- 5 sites in Russia
- Volunteers
- 368 people
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
Healthy Volunteer Study
An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device.
- Trial name
- NCT04836572
- Testing
- 3M 1529 Adhesive Tape
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- SQ Innovation, Inc.
Mucositis, Nephrotoxicity
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients.
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Trial name
- NCT03480971
- Testing
- Tempol
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Matrix Biomed, Inc.
Drug-Related Side Effects and Adverse Reactions, Iatrogenic Disorder
Association Between Genetic Variant Scores and DOACs (DARES2)
The study's objective is to evaluate the predictive accuracy of Cipherome's algorithm in predicting and preventing serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).
- Trial name
- NCT04597593
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.