Clinical trials: Response Evaluation
Multicentric Castleman's Disease
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial…
- Trial name
- NCT01024036
- Testing
- Siltuximab, Best Supportive Care (BSC)
- Where
- 56 sites in United States, Australia and 21 more
- Volunteers
- 79 people
- Sponsor
- Janssen Research & Development, LLC
High Risk MDS
Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.
The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with…
- Trial name
- NCT02159040
- Testing
- Azacitidine, Azacitidine plus Deferasirox
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Novartis Pharmaceuticals
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Biliary Cirrhosis (PBC)
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).
- Trial name
- NCT02609048
- Testing
- Experimental: Seladelpar 50 mg, Experimental: Seladelpar / MBX-8025 200 mg
- Where
- 49 sites in United States, Canada and 3 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Colon Cancer, Colorectal Cancer
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic…
- Conditions
- Colon Cancer, Colorectal Cancer, Rectal Cancer, Cancer
- Trial name
- PRECEPT (NCT00411450)
- Testing
- Panitumumab, FOLFIRI
- Volunteers
- 116 people
- Sponsor
- Amgen
Influenza, Human
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A)…
- Trial name
- NCT05823974
- Testing
- F2C22C/DL001Z, F2B22A/DL001Z, F2B22B/DL001Z
- Where
- 41 sites in United States, Belgium and 2 more
- Volunteers
- 1,275 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Uterine Cervical Neoplasms
FLT PET Imaging for Cervical Cancer
Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor. This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis.
- Trial name
- NCT01075412
- Testing
- [F18]Fluorothymidine
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Iowa
Respiratory Syncytial Virus
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age.
- Trial name
- NCT06060457
- Testing
- mRNA-1345, Fluzone HD
- Where
- 34 sites in United States
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Major Depressive Disorder
Study to Evaluate the Effect and Safety of Quetiapine Extended Release (XR) (FK949E) in Major Depressive Disorder
In this study, quetiapine XR or placebo will be administered orally for 6 weeks to major depressive disorder patients with lack of response to existing antidepressants, with the aim of evaluating the efficacy of quetiapine XR and…
- Trial name
- NCT01725282
- Testing
- quetiapine extended release (XR)
- Where
- 3 sites in Japan
- Volunteers
- 172 people
- Sponsor
- Astellas Pharma Inc
Multiple Myeloma
UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide
Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for…
- Trial name
- NCT00574080
- Testing
- Interim/Maintenance Dexamethasone, Induction/Consolidation Dexamethasone, Induction/Consolidation Cisplatin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arkansas
HIV Infections
Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART
LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in…
- Trial name
- NCT00270205
- Testing
- LC002 standard vaccination, LC002 high-dose vaccination
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cervical Intraepithelial Neoplasia
A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.
- Trial name
- NCT05496231
- Testing
- HPV9 High formulation, HPV9 Medium formulation, HPV9 Low formulation
- Where
- 68 sites in United States, Bulgaria and 6 more
- Volunteers
- 1,080 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Gout
Combining Lesinurad With Allopurinol in Inadequate Responders
This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to…
- Trial name
- CLEAR 1 (NCT01510158)
- Testing
- Lesinurad, Allopurinol
- Where
- 165 sites in United States
- Volunteers
- 607 people
- Sponsor
- Ardea Biosciences, Inc.
Metastatic Melanoma
RFT-5-dgA in Patients With Metastatic Melanoma
Background: CD4+ cells are white blood cells that regulate the immune system by controlling the strength and quality of the immune response. CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses.
- Trial name
- NCT00314093
- Testing
- RFT5pdgA
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Texas Southwestern Medical Center
Ulcerative Colitis
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection.
- Trial name
- NCT01482884
- Testing
- tralokinumab
- Where
- 28 sites in Czechia, France and 4 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice
This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites.
- Trial name
- EUREKA (NCT02499263)
- Where
- 19 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- AbbVie
Diabetes Mellitus, Type 1
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo.
- Trial name
- DEFEND-2 (NCT01123083)
- Testing
- Otelixizumab
- Where
- Italy
- Volunteers
- 179 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rhinitis
SB705498 Proof of Concept Chamber Challenge in Subjects With Non Allergic Rhinitis
The purpose of this study is to assess the pharmacodynamic (PD) effects (Total Symptom Score (TSS) and its individual components: rhinorrhoea, nasal congestion, post-nasal drip) of intranasal, repeat dose SB-705498 in…
- Trial name
- NCT01424514
- Testing
- SB-705498
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Colitis, Ulcerative
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who…
- Trial name
- NCT02611830
- Testing
- Vedolizumab 300 mg IV, Vedolizumab 108 mg SC
- Where
- 174 sites in United States, Argentina and 29 more
- Volunteers
- 383 people
- Sponsor
- Takeda