Clinical trials: Toxicity
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Cancer
App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3
The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with…
- Trial name
- NCT06322992
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Daynamica, Inc.
Sickle Cell Disease, Umbilical Cord Blood
US Phase I Study of ECT-001-CB in Patients With Sickle-Cell Disease
The application of experimental hematopoietic cell transplantation (HCT) therapy in sickle-cell disease (SCD) must strike a balance between the underlying disease severity and the possibility of a direct benefit of the treatment…
- Conditions
- Sickle Cell Disease, Umbilical Cord Blood, Hematopoietic Cell Proliferation
- Trial name
- NCT04594031
- Testing
- ECT-001-CB (UM171-Expanded Cord Blood Transplant)
- Where
- 2 sites in United States
- Sponsor
- ExCellThera inc.
Osteosarcoma
Investigation of [6R] 5,10-methylenetetrahydrofolate (Arfolitixorin) as Rescue Therapy for Osteosarcoma Patients Treated With HDMTX.
An open-label, multicenter, phase I/II clinical trial to identify the [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) dose with most favorable safety prospect and confirmed ability to mitigate high-dose methotrexate induced…
- Trial name
- NCT01987102
- Testing
- Calcium Folinate, [6R] 5,10-methylenetetrahydrofolate (arfolitixorin)
- Where
- 5 sites in Czechia, Hungary and 2 more
- Volunteers
- 18 people
- Sponsor
- Isofol Medical AB
Hairy Cell Leukemia
US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of…
- Trial name
- PROXY (NCT04125290)
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- AstraZeneca
Serotonin Syndrome
Azilect + Antidepressant Chart Review
To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD…
- Trial name
- STACCATO (NCT00955604)
- Testing
- Group R+AD Rasagiline + Antidepressant, Group R Rasagiline, Group AD Anti-PD + Antidepressant
- Volunteers
- 1,500 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Mercury Poisoning
NBMI Treatment in Patients With Mercury Toxicity
NBMI (N1, N3-Bis-(2-Mercaptoethyl) Isophthalamide) is a new metal chelator drug proposed as an alternative to the current chelators, and it is widely different; compared to the current chelators, consisting of two cysteamine…
- Trial name
- NBMI-Hg-COL (NCT04183595)
- Testing
- (N1, N3-bis(2- mercaptoethyl)isophthalamide), Excipients microcrystalline cellulose, silica and magnesium stearate
- Where
- Colombia
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- EmeraMed
Solid Tumors
Panitumumab in Children With Solid Tumors
The primary objective of this study was to evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric patients with solid tumors.
- Trial name
- NCT00658658
- Testing
- Panitumumab
- Where
- 11 sites in United States
- Volunteers
- 31 people
- Sponsor
- Amgen
Toxicity
Case Control Study of Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure to Lapaquistat Acetate
The purpose of this study is to examine the genetic contribution to the mechanism of lapaquistat acetate- induced hepatic abnormalities.
- Trial name
- NCT00890448
- Testing
- Pharmacogenomic whole blood sampling
- Where
- 19 sites in United States, Argentina and 12 more
- Volunteers
- 66 people
- Sponsor
- Takeda
Meningitis, Cryptococcal, HIV Infections
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.
- Trial name
- NCT00002306
- Testing
- Fluconazole
- Where
- 14 sites in United States
- Sponsor
- Pfizer
Transfusional Iron Overload
A Protocol to Allow Treatment With ICL670 for Patients With or at Risk of Life-threatening Complications of Transfusional Iron Overload Who Are Unable to Tolerate Other Iron Chelators Because of Documented Severe Toxicity
The purpose of this open-label, non-comparative, multi-center protocol was to further evaluate safety and to provide treatment with ICL670 to patients who had or were at risk of life threatening complications due to transfusional…
- Trial name
- NCT01044186
- Testing
- ICL670
- Where
- 18 sites in United States, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Neoplasms
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group…
- Trial name
- NCT01971476
- Testing
- volasertib
- Where
- 5 sites in Belgium, Czechia and 3 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Radiosensitivity, Pediatric Cancer
Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology
Analysis of the individual radiosensitivity in pediatric oncology
- Conditions
- Radiosensitivity, Pediatric Cancer, Radiation Toxicity
- Trial name
- FOCUSO (NCT06033183)
- Testing
- Blood sample
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- Neolys
Severe Hepatic Veno-Occlusive Disease
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of…
- Trial name
- NCT00358501
- Testing
- Defibrotide
- Where
- 25 sites in United States, Canada
- Volunteers
- 134 people
- Sponsor
- Jazz Pharmaceuticals
Systemic Fungal Infections
Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with…
- Trial name
- MYCOS (NCT01686607)
- Testing
- Parenteral micafungin application, Other parenteral antifungal drugs
- Where
- 6 sites in United States
- Volunteers
- 40,110 people
- Sponsor
- Astellas Pharma Europe B.V.
EBV-induced Lymphomas, EBV-associated Malignancies
Biological Therapy in Treating Patients at High-Risk or With Lymphoma, Lymphoproliferative Disease, or Malignancies
The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
- Conditions
- EBV-induced Lymphomas, EBV-associated Malignancies, Transplant Patients With EBV Viremia at High Risk of Developing a Recurrent EBV Lymphoma
- Trial name
- NCT00002663
- Testing
- Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs)
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Atara Biotherapeutics
Relapsed or Refractory Classical Hodgkin Lymphoma
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
- Trial name
- NCT05216835
- Testing
- Sabestomig (AZD7789)
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Toxicity Due to Chemotherapy
Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
The purpose of this study is to provide emergency treatment of adult and pediatric patients: Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or Who exhibit early-onset, severe or…
- Trial name
- NCT01432301
- Testing
- uridine triacetate
- Sponsor
- Wellstat Therapeutics
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Cervical Cancer
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice…
- Trial name
- NCT01851772
- Testing
- Treatment with Electronic Brachytherapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Xoft, Inc.