Clinical trials: Safety and Tolerability
Chronic Graft-versus-host-disease
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received…
- Trial name
- AGAVE-201 (NCT04710576)
- Testing
- Axatilimab
- Where
- 121 sites in United States, Australia and 14 more
- Volunteers
- 296 people
- Sponsor
- Syndax Pharmaceuticals
ADHD, Attention Deficit Hyperactivity Disorder
Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
- Trial name
- NCT00585910
- Testing
- Atomoxetine and OROS Methylphenidate
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Massachusetts General Hospital
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Malaria
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally…
- Trial name
- NCT03521973
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Gabon
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Attention Deficit Disorder With Hyperactivity
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
- Trial name
- NCT00151983
- Testing
- Methylphenidate Transdermal System
- Where
- 18 sites in United States
- Volunteers
- 175 people
- Sponsor
- Noven Therapeutics
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
Prophylaxis of Avian Influenza
Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years
Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination
- Trial name
- NCT00537524
- Testing
- H5N1 Influenza Vaccine
- Where
- Finland
- Volunteers
- 471 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Obese Adolescents, Obesity
A Study of XW003 Injection in Chinese Adolescents With Obesity
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity
- Trial name
- NCT07143227
- Testing
- XW003 injection
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
Healthy Subjects, Pneumococcal Infections
Study Evaluating Pneumococcal Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
- Trial name
- NCT00205803
- Testing
- 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
- Where
- United States
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Primary Immune Deficiency
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases
- Trial name
- NCT04640142
- Testing
- Newnorm
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 50 people
- Sponsor
- Octapharma
Malaria
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
Background: Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies.
- Trial name
- NCT03989102
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 324 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Inherited Retinal Diseases
Safety and Efficacy Study of PUMCH-E101 Injection in Subjects with RDH12 Retinopathy
The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E101 injection in subjects with RDH12 retinopathy.
- Trial name
- NCT06749639
- Testing
- PUMCH-E101 Injection(Low dose), PUMCH-E101 Injection(High dose)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peking Union Medical College Hospital
Secondary Hyperparathyroidism
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label, active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet HCl for the treatment of Secondary…
- Trial name
- NCT01479088
- Testing
- Cinacalcet HCl
- Where
- 5 sites in Italy
- Volunteers
- 30 people
- Sponsor
- ENRICO VERRINA
Cystic Fibrosis
Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P.
- Trial name
- NCT03905642
- Testing
- Arikayce™
- Where
- 11 sites in Belgium, Hungary and 5 more
- Volunteers
- 49 people
- Sponsor
- Insmed Incorporated
Gaucher Disease, Type 1, Gaucher Disease, Type 3
Phase 1/2 Study of CAN103 in Subjects With Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by deficient activity of the enzyme acid β-glucosidase, causing glucosylceramide to accumulate within macrophages and leading to hepatosplenomegaly, anemia…
- Trial name
- NCT05447494
- Testing
- Low-dose CAN103, High-dose CAN103
- Where
- China
- Volunteers
- 40 people
- Sponsor
- CANbridge (Suzhou) Bio-pharma Co., Ltd.
Influenza
Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Liquid Formulation (CAIV-T), Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
The primary objective of the study was to determine if intranasally administered influenza virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles…
- Trial name
- NCT00192166
- Testing
- CAIV-T
- Where
- Singapore
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Primary Immunodeficiency (PID)
Subcutaneous Ig NextGen 16% in PID Patients
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP.
- Trial name
- NCT00391131
- Testing
- IgNextGen 16%
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 35 people
- Sponsor
- CSL Limited
Tuberculosis, HIV
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
Single-arm, multi-center, Phase I/II clinical trial, in two groups. Individuals with HIV infection taking Efavirenz (EFV), nevirapine (NVP) or lopinavir/ritonavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTI)…
- Trial name
- DOLPHIN KIDS (NCT05122767)
- Testing
- Dolutegravir, 3HP
- Where
- 2 sites in South Africa
- Volunteers
- 92 people
- Sponsor
- The Aurum Institute NPC
Pediatric Hypertension With or Without CKD
Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.
- Trial name
- NCT01617681
- Testing
- VAL489
- Where
- 27 sites in Belgium, Brazil and 7 more
- Volunteers
- 127 people
- Sponsor
- Novartis Pharmaceuticals
Graft Versus Host Disease in Eye
Evaluation of 0.05% CsA and 0.1% FK506 Eye Drops in Ocular GVHD Treatment
It is planned to explore the efficacy and safety of local 0.05% cyclosporine eye drops in the treatment of chronic graft-versus-host eye disease.
- Trial name
- NCT05294666
- Testing
- Cyclosporine, tacrolimus
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Peking University Third Hospital
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