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NCT ID: NCT00168103 Completed - Clinical trials for Hereditary Angioedema

Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks

Start date: June 2005
Phase: Phase 2/Phase 3
Study type: Interventional

HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.

NCT ID: NCT00168077 Completed - Clinical trials for Acquired Coagulation Factor Deficiency

Prothrombin Complex Concentrate for Anticoagulant Reversal

Start date: September 2005
Phase: Phase 3
Study type: Interventional

Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

NCT ID: NCT00162526 Withdrawn - Oral Mucositis Clinical Trials

Tocopherol is a Novel Treatment for Cancer Related Mucositis

Start date: December 2005
Phase: Phase 2
Study type: Interventional

The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.

NCT ID: NCT00162513 Withdrawn - Clinical trials for Chronic Myeloid Leukemia

Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Start date: December 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches. Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated. The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.

NCT ID: NCT00162500 Withdrawn - Multiple Myeloma Clinical Trials

A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

Start date: n/a
Phase: Phase 2
Study type: Interventional

Rationale: ImMucin was shown to be able to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the majority of the target population. Purpose: The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA).

NCT ID: NCT00162487 Recruiting - Clinical trials for Chronic Renal Failure

Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

Start date: August 2002
Phase: N/A
Study type: Interventional

Several studies have indicated that albuterol administered either intravenously or by inhalation can significantly reduce plasma potassium concentration in patients suffering from chronic renal failure.In conjunction with the decrease in potassium concentration a modest rise in glucose concentration is usually noted. These metabolic effects are characterized by rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting for at least 1 hour. The role played by ß2AR polymorphisms in determining the bronchial and vascular response to ß2AR agonist drugs, have been confirmed by several studies. The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled albuterol.

NCT ID: NCT00162474 Recruiting - Healthy Clinical Trials

Determinants of Warfarin Metabolism

Start date: September 2003
Phase: N/A
Study type: Interventional

The anticoagulant effect of warfarin varies greatly among individuals. Some of this variability is attributed to differences in the activity of CYP2C9, the predominant enzyme involved in the metabolism of S-warfarin. The present study is designed to define the differences in warfarin metabolism among healthy individuals carrying different CYP2C9 genotypes. In addition, the study will define the correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and warfarin metabolism.

NCT ID: NCT00162461 Recruiting - Healthy Clinical Trials

Evaluation of CYP2C9 Activity

Start date: August 1998
Phase: N/A
Study type: Interventional

The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9. The purpose of the present study is: 1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity 2. To correlate phenytoin metabolic ratio with CYP2C9 genotype 3. To study the frequency distribution of CYP2C9 activity in-vivo

NCT ID: NCT00162435 Recruiting - Atrial Fibrillation Clinical Trials

Genetic Determinants of Warfarin Anticoagulation Effect

Start date: August 2002
Phase: N/A
Study type: Interventional

The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments: 1. Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population. 2. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period. 3. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects.

NCT ID: NCT00162422 Recruiting - Asthma Clinical Trials

Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

Start date: August 2003
Phase: N/A
Study type: Interventional

The role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist drugs, has been confirmed by several studies. The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo model (organ bath technique) will be used to investigate association between polymorphisms in the coding region of ß2AR and the response of bronchial rings derived from human lung tissue to the respective agonists (i.e. salbutamol). In the second part of the study the same bronchial rings will be incubated for 24 hours in a solution containing fixed concentration of albuterol. A second dose response curve for rising concentrations of albuterol will be constructed and a relationship between β2 genetic polymorphisms and the extent of desensitization to albuterol will be investigated. In addition, through specifically designed receptor binding assay the bronchial tissue will be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will enable to enhance our understanding regarding the mechanism responsible for the association noted between ß2AR polymorphism and altered drug effect.