Clinical trials: Safety
Malignant Pleural Mesothelioma
Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma
This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard of care chemotherapy (pemetrexed and cisplatin).
- Trial name
- NCT01675765
- Testing
- Immunotherapy plus chemotherapy, Immunotherapy with cyclophosphamide plus chemotherapy
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Aduro Biotech, Inc.
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Influenza
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune…
- Trial name
- NCT01229371
- Testing
- Inflexal V influenza vaccine (CSL HA Antigen) 2010, Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011
- Where
- 2 sites in Switzerland
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Dermatitis, Dermatitis, Atopic
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis.
- Conditions
- Dermatitis, Dermatitis, Atopic, Eczema, Skin Diseases
- Trial name
- NCT03627767
- Testing
- PF-04965842 100 mg, PF-04965842 200 mg
- Where
- 235 sites in United States, Argentina and 19 more
- Volunteers
- 1,235 people
- Sponsor
- Pfizer
Herpes Zoster, Herpes Zoster Vaccine
Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of the GSK Biologicals HZ/su candidate vaccine when its first dose is co-administered with Pneumovax 23™ vaccine in adults aged 50 years or…
- Trial name
- NCT02045836
- Testing
- Herpes Zoster vaccine GSK 1437173A, Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 865 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Allergic Conjunctivitis
The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
- Trial name
- NCT04207736
- Testing
- Reproxalap Ophthalmic Solution (0.25%), Vehicle Ophthalmic Solution
- Where
- Canada
- Volunteers
- 95 people
- Sponsor
- Aldeyra Therapeutics, Inc.
Multiple Myeloma
A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma
The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone…
- Trial name
- NCT00622336
- Testing
- CC-5013, Lenalidomide
- Where
- 7 sites in Russia, Ukraine
- Volunteers
- 330 people
- Sponsor
- Celgene
Asthma
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of…
- Trial name
- NCT01147744
- Testing
- Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, GSK2190915 10mg
- Where
- 84 sites in United States, Bulgaria and 4 more
- Volunteers
- 700 people
- Sponsor
- GlaxoSmithKline
Papillomavirus Infections
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.
- Trial name
- NCT00380367
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Transplantation
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00400400
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil
- Where
- 53 sites in United States
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Thyroid Eye Disease
Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study
The overall objective is to evaluate the safety and efficacy of teprotumumab in the treatment of thyroid eye disease (TED) in participants who participated in the lead-in study HZNP-TEP-301 (NCT03298867; OPTIC) and who were…
- Trial name
- OPTIC-X (NCT03461211)
- Testing
- Teprotumumab
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 51 people
- Sponsor
- Amgen
Polycythemia Vera (PV)
Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply
This is a Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.
- Trial name
- NCT04182100
- Testing
- P1101, Low-dose aspirin, Phlebotomy
- Where
- 8 sites in Japan
- Volunteers
- 29 people
- Sponsor
- PharmaEssentia Japan K.K.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer
Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.
- Trial name
- NCT05021900
- Testing
- Tenalisib 800mg, Tenalisib 1200mg
- Where
- 3 sites in Georgia
- Volunteers
- 40 people
- Sponsor
- Rhizen Pharmaceuticals SA
Pain, Knee Osteoarthritis
A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR) tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with moderate to severe chronic pain due to…
- Trial name
- NCT00486811
- Testing
- Tapentadol ER (100 to 250 mg twice daily), Oxycodone CR (20 to 50 mg twice daily)
- Where
- 100 sites in Austria, Croatia and 11 more
- Volunteers
- 990 people
- Sponsor
- Grünenthal GmbH
Type 2 Diabetes
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin…
- Trial name
- NCT01034111
- Testing
- Sitagliptin phosphate, Metformin
- Volunteers
- 30 people
- Sponsor
- Merck Sharp & Dohme LLC
Osteoarthritis of the Knee
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects…
- Trial name
- NCT02067611
- Testing
- X0002
- Where
- 20 sites in United States
- Volunteers
- 216 people
- Sponsor
- Lina Xu
Moderate to Severe Ulcerative Colitis
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo.
- Trial name
- NCT04090411
- Testing
- Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, Induction- PF-06480605 450 mg SC Q4W
- Where
- 166 sites in United States, Australia and 21 more
- Volunteers
- 246 people
- Sponsor
- Hoffmann-La Roche
Pompe Disease
First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221
This is an international, multi-center, open-label study designed to evaluate if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults with Pompe disease.
- Trial name
- NCT02675465
- Testing
- ATB200, AT2221
- Where
- 19 sites in United States, Australia and 4 more
- Volunteers
- 29 people
- Sponsor
- Amicus Therapeutics
Ileostomy - Stoma, Inflammatory Bowel Diseases
Stoma Closure and Reinforcement Trial ll
Hernia formation at sites of ostomy closure is a common complication. The investigator believes that using evidence based hernia repair techniques as a preventive measure during closure of ostomies will reduce the incidence of…
- Trial name
- SCAR-ll (NCT04916067)
- Testing
- Mesh Implantation
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
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