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NCT ID: NCT01625390 Completed - Clinical trials for Hemophilia A, Hemophilia B

A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability. The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process. The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months. Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study. Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

NCT ID: NCT01625338 Completed - Chronic Hepatitis C Clinical Trials

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

NCT ID: NCT01625182 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Start date: December 22, 2012
Phase: Phase 3
Study type: Interventional

The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

NCT ID: NCT01624493 Withdrawn - Ovarian Cancer Clinical Trials

BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients

Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.

NCT ID: NCT01624246 Completed - Clinical trials for Systemic Inflammatory Response Syndrome (SIRS)

Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

Start date: May 2012
Phase: Phase 1
Study type: Interventional

To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).

NCT ID: NCT01624142 Completed - Clinical trials for Severe Familial Hypercholesterolemia

Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders

TAUSSIG
Start date: June 1, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

NCT ID: NCT01622088 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Phase 3 Extension Study of Dexpramipexole in ALS

ENVISION
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

NCT ID: NCT01621087 Completed - Clinical trials for Coronary Heart Disease

Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT

Start date: February 1966
Phase: N/A
Study type: Interventional

The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction. However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973) was a randomized controlled secondary CHD prevention trial testing whether selectively increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A full analysis of mortality outcomes has not been published. The investigators recovered the original SDHS dataset, which included detailed longitudinal dietary, smoking and coded mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also permitted the first complete meta-analysis of LA intervention trials on mortality outcomes. Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed mortality differences.

NCT ID: NCT01620801 Terminated - Hemophilia B Clinical Trials

Hemophilia B Gene Therapy With AAV8 Vector

Start date: October 2012
Phase: Phase 1
Study type: Interventional

Hemophilia B is a bleeding disease in males due to very low levels of coagulation factor IX (FIX) in the blood. The current treatment is intravenous injection of FIX clotting factor concentrates, in response to bleeding. This study will focus on the severe, most common type of hemophilia B. This study plans to use a virus called adeno-associated virus (AAV), which in nature causes no disease, and can be engineered to deliver the human FIX gene (AAV8-hFIX19 vector) to liver cells, where FIX is normally made. This study will use the AAV8-hFIX19 vector.

NCT ID: NCT01620749 Active, not recruiting - Metastatic Melanoma Clinical Trials

Of 18F MEL050 Using PET/CT in Metastatic Melanoma

MEL050
Start date: June 2010
Phase: Phase 0
Study type: Interventional

The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.