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NCT ID: NCT01016392 Completed - Clinical trials for Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency

Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency

KAMPER
Start date: December 2009
Phase:
Study type: Observational [Patient Registry]

Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine. Kuvan® received marketed authorisation in Europe in December 2008 and is now available in several European countries for the treatment of Hyperphenylalaninemia (HPA). The primary objective is to assess the long-term safety in subjects treated with Kuvan®. Secondary objectives are to provide additional information regarding: - Safety in specific subject groups (elderly, pediatric, pregnant women and subjects with renal or hepatic insufficiency). - Growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (HPA) who are receiving treatment with Kuvan®. - Progress and outcome of pregnancy for women with HPA who become pregnant while receiving treatment with Kuvan® (these women will be enrolled in a dedicated sub-registry). - Assessment of adherence to diet and to Kuvan®. - Assessment of long-term sensitivity to Kuvan®treatment.

NCT ID: NCT01015248 Completed - MALT LYMPHOMA Clinical Trials

Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma

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

The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas. Primary endpoint: - Event-free-survival (EFS) (failure or death from any cause) for all patients. Secondary endpoints: - Complete and partial remission rates for all patients - Response duration (time to relapse or progression) for responder patients - Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients - Overall survival for all patients - Acute and long-term toxicity

NCT ID: NCT01015118 Completed - Ovarian Neoplasms Clinical Trials

LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer

Start date: November 17, 2009
Phase: Phase 3
Study type: Interventional

The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

NCT ID: NCT01014988 Completed - Influenza, Human Clinical Trials

Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

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

The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.

NCT ID: NCT01014975 Completed - Clinical trials for Acute Ischemic Stroke

A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

NCT ID: NCT01014390 Completed - Biliary Stricture Clinical Trials

WallFlex Biliary Fully Covered (FC) Benign Stricture Study

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

The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

NCT ID: NCT01014208 Completed - Clinical trials for Lymphoma, Large-Cell, Diffuse

Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

ORCHARRD
Start date: March 2010
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.

NCT ID: NCT01012921 Completed - Degeneration; Bone Clinical Trials

Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants

Start date: September 2009
Phase: N/A
Study type: Interventional

The aim of the study is to test in a randomized comparative study the performance of Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann® SLActive bone level titanium implants. Furthermore the clinical evaluation and comparison of complementary parameters describing the bony and soft tissue environments at the surgical sites during the study period to evaluate effectiveness and performance of the membranes.

NCT ID: NCT01012037 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

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

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

NCT ID: NCT01011205 Completed - Clinical trials for Liver Transplantation

Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

DIAMOND
Start date: September 30, 2009
Phase: Phase 3
Study type: Interventional

Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.