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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

paradigmâ„¢ 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: NCT01386281 Completed - Clinical trials for Osteoporosis, Postmenopausal

Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

JULINA-CLIMA
Start date: October 20, 2008
Phase:
Study type: Observational

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.

NCT ID: NCT01384903 Completed - Clinical trials for Disseminated Intravascular Coagulation (DIC)

An Open-label Study of KW-3357

3357-004
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.

NCT ID: NCT01384682 Completed - HIV Clinical Trials

Maraviroc Switch Collaborative Study

MARCH
Start date: August 2011
Phase: Phase 4
Study type: Interventional

MARCH is an international, multicentre trial planning to enroll 380 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic assessment of tropism cannot be used to determine tropism, instead we will employ the genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim of this study is to investigate whether switching to maraviroc, in combination with either RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r. The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies/mL) patients with no history of prior virological failure, a switch to either MVC dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.

NCT ID: NCT01384617 Completed - Pancreatic Cancer Clinical Trials

Trial Assessing Roux-en-Y Anastomosis of the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

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

The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

NCT ID: NCT01384435 Completed - SCD Clinical Trials

A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

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

The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).

NCT ID: NCT01384396 Completed - Clinical trials for Disseminated Intravascular Coagulation (DIC)

A Clinical Study of KW-3357 in Patients With DIC

3357-005
Start date: December 2011
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by the diagnostic criteria for DIC established by the Japanese Ministry of Health and Welfare.

NCT ID: NCT01383993 Completed - Clinical trials for Aspergillosis, Aspergilloma

Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

Start date: September 2011
Phase: Phase 2
Study type: Interventional

In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to less than 15 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.

NCT ID: NCT01382329 Completed - H5N1 Influenza Clinical Trials

H5N1 Vaccine Study in Japanese Adults

Start date: June 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.

NCT ID: NCT01381965 Completed - Macular Holes Clinical Trials

Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery

Start date: March 2008
Phase: N/A
Study type: Interventional

Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.