Clinical trials: Immune Tolerance
Prader Willi Syndrome
Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants
The Prader-Willi syndrome (PWS) includes severe neonatal hypotonia with impaired suckling leading to failure to thrive in the most severe cases, subsequently followed by an early onset of morbid obesity with hyperphagia and…
- Trial name
- OTBB2 (NCT02205034)
- Testing
- oxytocin
- Where
- France
- Volunteers
- 18 people
- Sponsor
- University Hospital, Toulouse
Type 2 Diabetes
Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids…
- Trial name
- NCT01633177
- Testing
- Vitamin D3, Omega-3 fatty acid (fish oil)
- Where
- United States
- Volunteers
- 22,220 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Liver Transplant, Liver Transplantation
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation
The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
- Trial name
- OPTIMAL (NCT02533180)
- Testing
- Immunosuppression withdrawal
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Diabetes, Hyperglycemia
Insulin Secretion in Diabetes Before and After Glycemic Control
The objective of this project is to understand defects in insulin secretion that contribute to abnormal glucose metabolism in patients with diabetes.
- Trial name
- NCT00469833
- Testing
- insulin glargine
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Peanut Hypersensitivity
Peanut Oral Immunotherapy in Children
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children.
- Trial name
- IMPACT (NCT01867671)
- Testing
- Peanut Oral Immunotherapy - Liquid Extract, Peanut Oral Immunotherapy - Peanut Flour
- Where
- 5 sites in United States
- Volunteers
- 146 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Haemophilia A
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients…
- Trial name
- NCT03588741
- Testing
- Turoctocog alfa
- Where
- 14 sites in Austria, Bulgaria and 5 more
- Volunteers
- 1 people
- Sponsor
- Novo Nordisk A/S
Safety Issues, Tolerance
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy Subjects
This is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in…
- Conditions
- Safety Issues, Tolerance, Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
- Trial name
- NCT05427253
- Testing
- C106 solution
- Where
- Sweden
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vicore Pharma AB
Allergic Rhinoconjunctivitis, Grass Pollen Allergy
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
The primary objective of this study is to assess whether the combination of grass allergen sublingual immunotherapy (SLIT) and dupilumab for 2 years is more effective than double placebo in suppressing the nasal allergen…
- Trial name
- GRADUATE (NCT04502966)
- Testing
- Dupixent®, Grazax®
- Where
- United Kingdom
- Volunteers
- 199 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cystic Fibrosis
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.
- Trial name
- NCT02875366
- Testing
- LUM/IVA
- Where
- 12 sites in Australia, United Kingdom
- Volunteers
- 70 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Progressive Desmoids Tumors
PAZOPANIB Efficacy and Tolerance in Desmoids Tumors
Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at diagnosis is about 30 years.
- Trial name
- DESMOPAZ (NCT01876082)
- Testing
- PAZOPANIB treatment, Active Comparator: Vinblastine and Methotrexate
- Where
- France
- Volunteers
- 72 people
- Sponsor
- Institut Bergonié
Prediabetic State
Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
The purpose of this study is to determine if, in a subset of patients treated with a beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour oral glucose tolerance test (OGTT) compared to fasting…
- Trial name
- NCT01099397
- Testing
- Oral glucose tolerance test
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Florida
Multiple Myeloma
Elotuzumab, Lenalidomide and Dexamethasone in Treatment of Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients
This is a phase 2, single arm, open-label, multicenter study to evaluate the feasibility and tolerance of the combination of elotuzumab, lenalidomide, and dexamethasone in the induction, consolidation, and maintenance treatment…
- Trial name
- NCT02843074
- Testing
- elotuzumab, Lenalidomide, Dexamethasone
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- SCRI Development Innovations, LLC
Diabetes Mellitus, Type 1
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 [Ala-Ala],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection.
- Trial name
- AbATE (NCT00129259)
- Testing
- Anti-CD3 mAb, Diabetes Standard of Care Treatment, Iron supplementation
- Where
- 7 sites in United States
- Volunteers
- 83 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Ulcerative Colitis, Crohn's Disease
Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate
Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron…
- Trial name
- NCT01991314
- Testing
- Ferrous sulphate
- Where
- United Kingdom
- Volunteers
- 90 people
- Sponsor
- Queen Mary University of London
Performance of Colonoscopy, Tolerance of Colonoscopy
Abdominal Binder in Colonoscopies Performed by Trainees
This randomized trial will be conducted to evaluate the effectiveness and safety of an abdominal binder use during colonoscopy performed by gastrointestinal endoscopy fellow trainees.
- Trial name
- NCT05617521
- Testing
- Abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt), Loose abdominal binder (Revive 3-in-1 Postpartum Recovery Support Belt)
- Where
- Mexico
- Volunteers
- 211 people
- Sponsor
- Hospital Central Norte PEMEX
Skin Care
A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin
To determine the local cutaneous and ocular tolerance of a developmental cosmetic facial serum in healthy females with sensitive facial skin under normal conditions of use.
- Trial name
- NCT03640832
- Testing
- Developmental Serum, Physiogel Calming Relief Anti-Redness Serum
- Where
- Germany
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Ovarian Neoplasms
A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian…
- Trial name
- NCT00727961
- Testing
- Pegylated Liposomal Doxorubicin hydrochloride
- Volunteers
- 58 people
- Sponsor
- Merck Sharp & Dohme LLC
Acne Vulgaris
Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl…
- Trial name
- NCT00926367
- Testing
- Clindamycin and benzoyl peroxide, benzoyl peroxide 2.5% and adapalene 0.1% gel
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Stiefel, a GSK Company
Pre-diabetes, Impaired Fasting Glucose
Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy
The investigators hypothesize that sitagliptin will significantly reduce impairments in insulin secretion and insulin resistance resulting from short-term oral glucocorticoid therapy.
- Conditions
- Pre-diabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
- Trial name
- NCT01488279
- Testing
- Dexamethasone 2.5 mg and Sitagliptin 100 mg
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Vermont
Peanut Hypersensitivity, Food Allergy
FARE Peanut SLIT and Early Tolerance Induction
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization.
- Conditions
- Peanut Hypersensitivity, Food Allergy, Food Hypersensitivity, Peanut Allergy
- Trial name
- FARE/SLIT (NCT02304991)
- Testing
- Liquid Peanut Extract
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- University of North Carolina, Chapel Hill