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NCT ID: NCT01392547 Completed - Clinical trials for Congenital Bleeding Disorder

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

adept™2
Start date: July 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

NCT ID: NCT01392079 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Subcutaneous Alemtuzumab Combined With Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allo-SCT in CLL With 17p- or Refractory to Fludarabine

Start date: February 2008
Phase: Phase 2
Study type: Interventional

Aims and objectives - Assessment of the efficacy of the study treatment in the study population in terms of response rate, progression-free survival, failure-free survival and overall survival. - Acquisition of further data to expand the data base on the toxicity of the study treatment. - Assessment of the efficacy of the study treatment in biological risk groups. - Assessment of response in terms of minimal residual disease. Number of patients and estimated duration Total no. of patients: 122 (~29 with 17p deletion for first-line therapy, ~29 with 17p deletion for second- or higher-line treatment, ~65 fludarabine-refractory irrespective of 17p status). Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two years maintenance treatment.

NCT ID: NCT01390948 Completed - High Grade Glioma Clinical Trials

A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma

Start date: October 18, 2011
Phase: Phase 2
Study type: Interventional

This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms. Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.

NCT ID: NCT01390480 Completed - Type 1 Diabetes Clinical Trials

Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes

Start date: November 2010
Phase: Phase 4
Study type: Interventional

In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

NCT ID: NCT01388361 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

BEGIN™
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes. Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

NCT ID: NCT01387594 Completed - Ulcerative Colitis Clinical Trials

Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs

TOSCA
Start date: May 3, 2012
Phase: Phase 1
Study type: Interventional

Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.

NCT ID: NCT01386658 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

Start date: January 27, 2012
Phase: Phase 3
Study type: Interventional

HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.

NCT ID: NCT01386528 Completed - Clinical trials for Congenital Bleeding Disorder

Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

paradigm™ 3
Start date: June 7, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

NCT ID: NCT01384838 Completed - Physical Activity Clinical Trials

Exercise Training in Postmenopausal Patients With Breast Cancer

Start date: June 2011
Phase: N/A
Study type: Interventional

This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program. All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized. All patients are to receive identical counseling for ideal nutritional, life-style and physical activity. Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.

NCT ID: NCT01380535 Completed - Clinical trials for Chronic Graft Versus Host Disease

Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

Start date: November 2011
Phase: Early Phase 1
Study type: Interventional

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in. This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.