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NCT ID: NCT01379508 Completed - Chronic Hepatitis B Clinical Trials

Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept

Start date: March 21, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety following the Roadmap Concept strategy with an initial monotherapy using either telbivudine or tenofovir in HBeAg negative CHB patients. The data from the study should allow for the validation of the Roadmap concept in a prospective manner, for both telbivudine and tenofovir treated HBeAg negative CHB patients. As part of a post-approval commitment to the European Health Authorities, the data will also be used to provide an optimized clinical treatment strategy for better clinical use of telbivudine in European HBeAg negative patients. Furthermore, the data from the study will contribute to a better scientific understanding, disease management and treatment of HBeAg negative CHB patients.

NCT ID: NCT01376700 Terminated - Hemophilia A Clinical Trials

Early Prophylaxis Immunologic Challenge (EPIC) Study

EPIC
Start date: August 26, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study was to assess if a once-weekly prophylactic regimen of 25 IU/kg ADVATE started at or before 1 year of age and before the onset of a severe bleeding phenotype (ie, joint bleeding), together with the minimization of immunological danger signals, can reduce the incidence rate of inhibitor formation in PUPs with severe and moderately severe hemophilia A.

NCT ID: NCT01376297 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Start date: July 2011
Phase: Phase 3
Study type: Interventional

NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

NCT ID: NCT01372384 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations

Start date: January 2012
Phase: Phase 2
Study type: Interventional

This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01369355 Completed - Crohn's Disease Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

Start date: September 13, 2011
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

NCT ID: NCT01369342 Completed - Crohn's Disease Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

Start date: July 2011
Phase: Phase 3
Study type: Interventional

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

NCT ID: NCT01367665 Completed - Clinical trials for Basal Cell Carcinoma

STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Start date: July 1, 2011
Phase: Phase 2
Study type: Interventional

This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

NCT ID: NCT01365546 Completed - Clinical trials for Prevent Bleeding in Major Surgery

Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery

WONDERS
Start date: June 2011
Phase: Phase 3
Study type: Interventional

Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.

NCT ID: NCT01363479 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

Start date: July 2011
Phase: Phase 3
Study type: Interventional

PALO-10-01 is a clinical study assessing efficacy and safety of a single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that oral palonosetron 0.50 mg is as effective as (non-inferior to) palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy.

NCT ID: NCT01361607 Completed - Pain Clinical Trials

Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

SPRAY III
Start date: May 27, 2011
Phase: Phase 3
Study type: Interventional

This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.