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Glassia Medical Research Studies

Up-to-date List of Glassia Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Glassia Medical Research Studies

Rank Status Study
1 Recruiting Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation.
Condition: Alpha 1 Antitrypsin Deficiency
Intervention: Drug: Alpha-1 Antitrypsin (human)
Outcome Measures: CHANGES IN CYTOKINE PROFILE IN BRONCHOALVEOLAR LAVAGE;   CHANGES IN SERUM INFLAMMATORY MARKERS;   EFFECT OF DOUBLE DOSE ZEMAIRA ON ELASTIN DEGRADATION;   EFFECT OF DOUBLE DOSE ZEMAIRA ON NEUTROPHIL APOPTOSIS AND MIGRATION;   CHANGES IN NEUTROPHILIC LUNG INFILTRATION;   NUMBER OF ADVERSE EVENTS REPORTED;   CHANGES IN METABOLIC AND COAGULATION PROFILES
2 Not yet recruiting A Research Trial of Aralast in New Onset Diabetes (RETAIN) - Part II
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Alpha 1-Antitrypsin (AAT, Aralast NP);   Drug: Placebo
Outcome Measures: Mixed-Meal Tolerance Test (MMTT)-stimulated 2-hour C-peptide Area under the curve (AUC);   MMTT-stimulated peak and 4-hour C-peptide AUC;   MMTT-stimulated 2-hour C-peptide AUC assessed longitudinally;   Insulin use in units per kilogram body weight per day;   Hypoglycemic events occurring from randomization;   Glycosylated hemoglobin (HbA1C) levels;   Emergence of anti-AAT antibodies;   Frequency and severity of all AEs (including infusion reactions, hypersensitivity reactions, and viral infections);   Changes in D-dimer levels indicating alteration in coagulant/anticoagulant balance;   Pharmacokinetic parameters of Aralast NP
3 Unknown  The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 Diabetes
Conditions: Diabetes;   Type 1 Diabetes
Intervention: Drug: Alpha 1-Antitrypsin (AAT, Aralast NP)
Outcome Measures: To assess participant safety & feasibility of study drug administration;   To assess AAT treatment on the maintenance of c-peptide production;   Assess the effects of AAT on glycemic variability and A1c.
4 Recruiting Phase II-III Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
Condition: New Onset Type-1 Diabetes
Interventions: Biological: Alpha-1 Antitrypsin;   Other: Placebo
Outcome Measures: Beta cell function;   Glycemic control;   Insulin dose;   Hypoglycemic episodes;   Safety parameters
5 Recruiting Alpha 1 Anti-Trypsin in Treating Patients With Acute Graft-Versus-Host Disease
Condition: Graft Versus Host Disease
Interventions: Other: laboratory biomarker analysis;   Other: pharmacological study;   Biological: alpha-1-proteinase inhibitor human
Outcome Measures: Number (percentage) of patients at each dosing cohort who experience no toxicity and in whom GVHD is stable or improved;   Change in plasma concentrations of alpha-1-proteinase inhibitor human at each dosing cohort;   Changes in pro-inflammatory cytokine levels at the messenger ribonucleic acid (mRNA) (by > polymerase chain reaction [PCR]) and protein (by enzyme-linked immunosorbent assay [ELISA]) levels at each dosing cohort;   Number (percentage) of patients at each dosing cohort with occurrence of infections;   Number (percentage) of patients at each dosing cohort with progression of GVHD;   Number (percentage) of patients at each dosing cohort experiencing an unexpected severe adverse event
6 Recruiting A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease
Condition: Graft vs Host Disease
Intervention: Drug: Alpha-1-Antitrypsin (AAT)
Outcome Measures: Response to Treatment;   Complete Response to Treatment;   Infection Rates;   Six month survival without additional GVHD therapy;   Analysis of plasma cytokine levels;   Analysis of plasma levels for Alpha-1-Antitrypsin (AAT)
7 Recruiting Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
Condition: Pulmonary Emphysema in Alpha-1 PI Deficiency
Interventions: Biological: Alpha1-proteinase inhibitor (human), modified process (Alpha-1 MP);   Other: 0.9% Sodium Chloride for Injection, USP
Outcome Measures: Change from Baseline in Whole lung PD15 (15th percentile point);   Adverse Events (AEs);   Serious Adverse Events (SAEs);   Discontinuations from the study due to AEs;   Severe COPD Exacerbations;   Change from Baseline in PD15 of the basal lung region
8 Recruiting Polygen Defi-Alpha: Genetic Polymorphisms Study in Children With Alpha-1 Antitrypsin Deficiency, Included in the DEFI-ALPHA Cohort
Condition: Children With a Deficiency of Alpha-1 Antitrypsin
Intervention: Other: blood sampling
Outcome Measures: presence of mutations / polymorphisms in genes SERPINA1, Ermani and KPNB1 (with haplotype interpretation) in children with hepatic complications;   measurement and interpretation of serum IL-8
9 Not yet recruiting Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
Interventions: Biological: 180 mg/kg Alpha1-PI;   Biological: 90 mg/kg Alpha1-PI;   Biological: Placebo
Outcome Measures: C-peptide Area Under the concentration-time Curve (AUC);   Number of subjects who discontinue due to Adverse Events (AEs);   Change from baseline for HbA1c levels;   Number of severe hypoglycemic episodes;   Serum alpha1-PI AUC;   Mean trough serum alpha1-PI
10 Recruiting Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
Intervention: Drug: Alpha 1-Antitrypsin
Outcome Measures: C reactive protein;   Left ventricular end-systolic volume change
11 Recruiting Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses
Condition: Neuromyelitis Optica
Interventions: Drug: Alpha1-antitrypsin;   Drug: methylprednisolone
Outcome Measures: Mean change in disability from baseline/nadir to week 24 as assessed by Opticospinal Impairment Score (OSIS) subscale.;   Mean change in disability from baseline/nadir to week 24 as assessed by Expanded Disability Status Scale (EDSS).;   For patients experiencing optic neuritis, mean change in visual acuity from baseline/nadir to week 24 as assessed by Sloan 2.5% low contrast visual acuity chart.;   Mean change in retinal nerve fiber layer from baseline/nadir to week 24 as assessed by optical coherence tomography (OCT).;   Mean change in length of spinal cord lesion from baseline/nadir to week 24 as assessed by magnetic resonance imaging (MRI) T2 sequences.
12 Recruiting Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency
Conditions: Alpha-1-antitrypsin Deficiency;   Liver Cirrhosis
Interventions: Drug: Drug-Carbamazepine (Tegretol XR);   Drug: Carbamazepine (Tegretol XR) Placebo
Outcome Measures: The primary outcome will be to determine the effect of Carbamazepine on hepatic ATZ load.;   For the secondary outcomes we will determine the effect of Carbamazepine treatment on hepatic fibrosis.;   For the secondary outcome we will determine if Carbamazepine treatment reduces the MELD score.
13 Recruiting Safety and Efficacy of (α1Proteinase Inhibitor, α1PI) in HIV Disease
Condition: HIV Disease
Interventions: Biological: α1 Proteinase Inhibitor;   Biological: Placebo
Outcome Measure: CD4 counts
14 Unknown  Endoscopic Lung Volume Reduction in Patients With Advanced Emphysema Due to alpha1 Antitrypsin Deficiency
Condition: Hereditary Emphysema (Alpha 1-antitrypsin Deficiency)
Intervention: Device: Implantation of intrabronchial valves (IBV) (Spiration IBV)
Outcome Measures: Improvement in pulmonary function (FEV1 (forced expiratory volume in 1 second) and RV/TLC (residual volume/total lung capacity);   Number of major complications;   Evaluation of IBV migration rate;   Average changes in pulmonary function (FEV1, VC (vital capacity), RV, TLC, RV/TLC);   Average changes in 6-minute-walk-distance
15 Recruiting Phase II, Safety and ELF Study of "Kamada-API for Inhalation"
Condition: Alpha-1 Antitrypsin Deficiency
Interventions: Biological: Kamada-API for Inhalation, 80mg;   Drug: Placebo;   Biological: Kamada-API for Inhalation, 160mg
Outcome Measures: Concentration of active AAT (Alpha-1 antitrypsin) in ELF;   Concentration of antigenic AAT (Alpha-1 antitrypsin) in ELF;   Safety and tolerability;   Concentration of active AAT in serum;   ELF inflammatory analytes
16 Recruiting Alpha-1 Antitrypsin Deficiency Adult Liver Study
Condition: Alpha-1 Antitrypsin Deficiency
Intervention: Procedure: Liver Biopsy
Outcome Measures: The risk and rate of histologic liver injury progression, as measured by liver biopsy, over a 5-year period.;   Calculated Model for End-stage Liver Disease score (MELD);   Liver synthetic dysfunction defined by international normalized ratio (INR) > 1.3 or serum albumin < 3.2 gm/dL;   Presence of ascites (or treatment for ascites);   Development of complications of portal hypertension (e.g., variceal hemorrhage);   Jaundice (total serum bilirubin >2.0 mg/dl);   Liver transplantation;   Listing for liver transplantation;   Health related quality of life;   FEV1 % of Predicted;   Death
17 Recruiting Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (AATD)
Conditions: Liver Fibrosis;   Alpha-1 Antitrypsin Deficiency;   AAT Deficiency;   AATD
Interventions: Device: Abdominal ultrasound;   Procedure: History and physical;   Procedure: Intravenous catheter;   Procedure: Blood draw;   Other: Liver questionnaire;   Procedure: Liver Biopsy;   Drug: Midazolam;   Drug: Fentanyl;   Drug: Lidocaine;   Drug: Acetaminophen;   Drug: Lorazepam;   Drug: Oxycodone/Acetaminophen;   Drug: Ondansetron
Outcome Measures: To estimate the prevalence and histologic spectrum of liver injury in an adult with Alpha-1 Antitrypsin deficiency and a genotype of ZZ.;   To identify environmental and host risk factors for clinically significant liver fibrosis.;   To define the diagnostic accuracy of non-invasive markers of fibrosis in AAT liver disease.;   To explore epigenetic markers for the development of liver fibrosis.;   To quantify liver fibrosis progression.
18 Recruiting Genomic Research in Alpha-1 Antitrypsin Deficiency
Conditions: Alpha 1 Antitrypsin Deficiency;   AATD
Intervention:
Outcome Measure: Number and diversity of lower respiratory tract (LRT) microbes
19 Recruiting Alpha-1 Coded Testing(ACT) Study
Condition: Alpha-1 Antitrypsin Deficiency
Intervention: Procedure: Alpha-1 Antitrypsin Genotype
Outcome Measure: Structured questionnaire responses on the risks and benefits of testing.
20 Unknown  Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema
Conditions: Alpha 1-Antitrypsin Deficiency;   Emphysema
Intervention:
Outcome Measure:

These studies may lead to new treatments and are adding insight into Glassia etiology and treatment.

A major focus of Glassia research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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