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NCT ID: NCT01027884 Completed - Clinical trials for Muscular Dystrophy, Duchenne

Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

DELOS
Start date: July 2009
Phase: Phase 3
Study type: Interventional

The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.

NCT ID: NCT01027507 Completed - Heart Disease Clinical Trials

Postprandial Hemodynamics

Start date: January 2009
Phase: N/A
Study type: Observational

To study the postprandial alterations in hemodynamics and blood pressure in relation to gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety in healthy subjects.

NCT ID: NCT01027364 Completed - Severe Hemophilia B Clinical Trials

Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B

Start date: December 2009
Phase: Phase 3
Study type: Interventional

The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.

NCT ID: NCT01025804 Completed - Leukemia Clinical Trials

Pharmacokinetics of Asparaginase and Antibody Formation in Interfant-06

Start date: December 2009
Phase: N/A
Study type: Observational

Asparaginase is an important drug in the treatment of childhood leukemia including in infant (<1 year). The prognosis for infants is bad. Information about drug metabolism in neonates and infants is scarce as well as the reactions of an immature immune system to foreign proteins. The aims of this study is to describe the metabolism (pharmacokinetics) of asparaginase after administration intramuscularly and to evaluate the formation of antibodies against the drug (enzyme) during treatment in order to optimize the asparaginase treatment in infants in the future.

NCT ID: NCT01025778 Completed - Clinical trials for Acute Myeloid Leukemia

Haploidentical Stem Cell Transplantation for Children With Therapy Resistant Leukemia

Start date: December 2009
Phase: Phase 2
Study type: Interventional

Despite substantial progress in the treatment pediatric acute leukemia a significant number of children will experience primary or secondary resistance to the treatment. In other words it will be not possible to achieve remission using standard chemotherapy (primary resistance) or the patients will develop chemotherapy resistant relapse (secondary resistance). Children failing to achieve remission or children relapsing after previous allogeneic stem cell transplantation have short life expectancy and palliative treatment still remains the most reasonable option as the escalation of conventional chemotherapy is not longer effective. The role of Graft versus Leukemia effect was postulated as one of the mechanisms contributing to the leukemia control/eradication after transplantation of hematopoietic stem cells. In this study the investigators combine intensified multiagent Clofarabine containing chemotherapy with post-induction treatment intensification using reduced intensity conditioning followed by haploidentical hematopoietic stem cell transplantation. Introducing a new drug to the treatment of resistant leukemia the investigators want to achieve a response which allows us to proceed to immediate haploidentical transplantation. Using a haploidentical donor the investigators can avoid time consuming search for an unrelated donor and perform the transplantation at the optimal time-point. Combating therapy resistant leukemia the investigators would like to evoke and utilize potential Graft-versus-Leukemia effect which is much more pronounced in the haploidentical setting, as it is well documented that allogeneic transplantation with a matched donor is not effective in resistant disease. The use of best KIR mismatch donor and post-transplant donor lymphocyte infusion will be implemented in order to develop/intensify graft versus leukemia effect.

NCT ID: NCT01025661 Completed - Hip Osteoarthritis Clinical Trials

Effects of Chiropractic Care in Patients With Hip Osteoarthritis

Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of the study is to explore the short term effects of chiropractic care on pain and function in patients with hip osteoarthritis.

NCT ID: NCT01025206 Completed - Multiple Myeloma Clinical Trials

A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma

Start date: December 2009
Phase: Phase 1
Study type: Interventional

This is a first in human study which will assess the safety and tolerability of a monoclonal antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also be measured.

NCT ID: NCT01023789 Completed - Clinical trials for Coronary Artery Disease

ABSORB EXTEND Clinical Investigation

ABSORB EXTEND
Start date: January 2010
Phase: N/A
Study type: Interventional

The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.

NCT ID: NCT01023308 Completed - Multiple Myeloma Clinical Trials

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

PANORAMA-1
Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

NCT ID: NCT01022242 Completed - Surgical Adhesions Clinical Trials

Study of PXL01 Versus Placebo to Inhibit Adhesion Formation After Flexor Tendon Surgery

PHSU02
Start date: December 2009
Phase: Phase 2
Study type: Interventional

The objectives of the study are to assess efficacy, safety, and handling of PXL01 in patients with flexor tendon injury in zone I or II.