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NCT ID: NCT01218308 Completed - Influenza Clinical Trials

A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

Start date: December 9, 2010
Phase: Phase 3
Study type: Interventional

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogenicity and safety of the investigational vaccine.

NCT ID: NCT01217697 Approved for marketing - Clinical trials for Urogenital Neoplasms

Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).

NCT ID: NCT01217632 Terminated - Clinical trials for Liver Fibrosis Due to Chronic Hepatitis B Infection

A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

Start date: August 2010
Phase: Phase 2
Study type: Interventional

The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who are eligible for antiviral therapy.

NCT ID: NCT01215643 Completed - Chronic Pain Clinical Trials

Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN α2a in Chronic Hepatitis C Genotype 2 and 3 naïve Patients

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The study is to investigate whether DEB025 alone or in combination with either ribavirin or peg-IFNα2a is more efficient compared to SOC in treatment-naïve patients with HCV genotype 2 and 3. In addition, triple therapy with DEB025 plus SOC will be applied to patients not achieving RVR in the different arms.

NCT ID: NCT01210001 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Empagliflozin (BI 10773) in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.

NCT ID: NCT01206764 Completed - Clinical trials for Renal Cell Carcinoma

A Trial of Everolimis in Patients With Advanced Renal Cell Carcinoma.

Start date: November 11, 2009
Phase: Phase 4
Study type: Interventional

Renal cell carcinoma (RCC) accounts for more than 200,000 new cases of cancer and over 100,000 cancer deaths annually in the World (Ferlay, et al., 2004). It is estimated that there were about 15,000 new cases of RCC in the region that excludes the Americas, European Union and Japan. Renal cell carcinomas arise from the proximal tubal epithelium are more common in males than in females with an overall lifetime risk of 1 in 75 and a median age of diagnosis of 65 years. Everolimus (Certican®) has been approved since 2003 in more than 60 countries for the prevention of organ rejection in patients with renal and cardiac transplantation. Everolimus (RAD001) is a derivative of rapamycin, which acts as a signal transduction inhibitor. It targets mTOR, a key protein kinase regulating cell growth, proliferation, and survival. The mTOR pathway activity is modulated by the phosphatidylinositol-3-kinase (PI3K)/protein kinase B AKT (AKT) pathway, a pathway known to be deregulated in numerous human cancers. RAD001 (Afinitor®) has been investigated as an anticancer agent based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation; - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell hypoxia-inducible factor 1 (HIF-1) activity, VEGF production, and VEGF-induced proliferation of endothelial cells). Primary: To evaluate the PFS rate over time. Secondary: - To evaluate the disease control rate (stable disease [SD] + partial response [PR] + complete response [CR]); - To evaluate the objective response rate (ORR; where ORR = CR + PR) and duration; - To describe the safety profile of RAD001.

NCT ID: NCT01205178 Completed - Malaria Clinical Trials

G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)

Start date: July 2, 2009
Phase: Phase 1
Study type: Interventional

SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3 days. The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The current study will identify a dose of TQ within the target efficacious dose range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤ 25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).

NCT ID: NCT01202552 Completed - Influenza Clinical Trials

Two-site Intradermal Influenza Vaccination in Elderly

Start date: October 2010
Phase: N/A
Study type: Interventional

One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.

NCT ID: NCT01201733 Completed - Clinical trials for Scapulocostal Syndrome

Traditional Thai Massage and Brain Electrical Activity

Start date: August 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the immediate effect of traditional Thai massage on brain electrical activity in the patients with scapulocostal syndrome

NCT ID: NCT01200758 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

Start date: February 15, 2011
Phase: Phase 3
Study type: Interventional

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.