Recurrence News - LARVOL Sigma

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||||||||||  Remicade (infliximab) / J&J
Enrollment closed:  A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence (clinicaltrials.gov) -  May 24, 2012
P3, N=299, Active, not recruiting,  Sponsor: Janssen Biotech, Inc.
Recruiting --> Active, not recruiting

||||||||||  clopidogrel / Generic mfg., clopidogrel/aspirin / Generic mfg.
Trial completion:  COMPRESS: COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke (clinicaltrials.gov) -  May 21, 2012
P4, N=358, Completed,  Sponsor: Sanofi
Recruiting --> Active, not recruiting Recruiting --> Completed

||||||||||  celecoxib oral / Generic mfg.
Trial termination:  Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy (clinicaltrials.gov) -  May 20, 2012
P2, N=37, Terminated,  Sponsor: UNC Lineberger Comprehensive Cancer Center
Recruiting --> Completed Completed --> Terminated; Study stopped due to increased cardiovascular risks associated with Celebrex

|||||||||| New P3 trial: Lamotrigine Phase III Study in Bipolar I Disorder (clinicaltrials.gov) - May 17, 2012
P3, N=250, Recruiting, Sponsor: GlaxoSmithKline

|||||||||| Enrollment change: SPOC: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers (clinicaltrials.gov) - May 15, 2012
P4, N=75, Completed, Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Completed --> Terminated; Study stopped due to increased cardiovascular risks associated with Celebrex N=375 --> 75

|||||||||| Trial completion: SPOC: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence in Lung Cancers (clinicaltrials.gov) - May 15, 2012
P4, N=75, Completed, Sponsor: Centre Hospitalier Universitaire de Saint Etienne
N=375 --> 75 Recruiting --> Completed

|||||||||| Enrollment closed: Sulforaphane in Treating Patients With Recurrent Prostate Cancer (clinicaltrials.gov) - May 6, 2012
P2, N=20, Active, not recruiting, Sponsor: OHSU Knight Cancer Institute
Recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Enrollment change:  Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant (clinicaltrials.gov) -  May 1, 2012
P2, N=40, Completed,  Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting N=50 --> 40

||||||||||  emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Trial completion:  Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant (clinicaltrials.gov) -  May 1, 2012
P2, N=40, Completed,  Sponsor: Gilead Sciences
N=50 --> 40 Active, not recruiting --> Completed

||||||||||  letrozole / Generic mfg.
Enrollment closed:  Safety of Ovarian Stimulation With Letrozole and Gonadotropins in Breast Cancer Patients (clinicaltrials.gov) -  Apr 24, 2012
P=N/A, N=100, Active, not recruiting,  Sponsor: New York Medical College
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Enrollment change: New Therapy of Laryngeal Papilloma In Children (clinicaltrials.gov) - Apr 24, 2012
P2, N=1, Terminated, Sponsor: Boston University
Recruiting --> Active, not recruiting N=30 --> 1

|||||||||| New P3 trial: SANIBA: Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers (clinicaltrials.gov) - Apr 24, 2012
P3, N=33, Completed, Sponsor: Assistance Publique - H

||||||||||  oxaliplatin / Generic mfg.
New P2 trial, Surgery:  IPHC in Patients With Platinum-sensitive Recurrent Ovarian Cancer (clinicaltrials.gov) -  Apr 23, 2012
P2, N=30, Completed,  Sponsor: Catholic University of the Sacred Heart

|||||||||| Trial completion: "UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period (clinicaltrials.gov) - Apr 22, 2012
P3, N=150, Completed, Sponsor: Meshalkin Research Institute of Pathology of Circulation
N=30 --> 1 Recruiting --> Completed

||||||||||  Veldona (Interferon α lozenge) / Hayashibara, Otsuka, Amarillo
Trial completion, Combination therapy:  Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C (clinicaltrials.gov) -  Apr 19, 2012
P2, N=169, Completed,  Sponsor: Amarillo Biosciences, Inc.
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Votrient (pazopanib) / Novartis, BeiGene
Biomarker:  Neoadjuvant Pazopanib in Renal Cell Carcinoma (clinicaltrials.gov) -  Apr 19, 2012
P2, N=56, Recruiting,  Sponsor: UNC Lineberger Comprehensive Cancer Center
Active, not recruiting --> Completed N=40 --> 56

||||||||||  Votrient (pazopanib) / Novartis, BeiGene
Biomarker:  Neoadjuvant Pazopanib in Renal Cell Carcinoma (clinicaltrials.gov) -  Apr 19, 2012
P2, N=56, Recruiting,  Sponsor: UNC Lineberger Comprehensive Cancer Center
N=40 --> 56 Active, not recruiting --> Recruiting

|||||||||| New P1/2 trial: Safety Study of Replication-competent Adenovirus (Delta-24-rgd) in Patients With Recurrent Glioblastoma (clinicaltrials.gov) - Apr 18, 2012
P1/2, N=30, Recruiting, Sponsor: Erasmus Medical Center

||||||||||  Sutent (sunitinib) / Pfizer
Enrollment closed, P2 data:  Multimodality Phase II Study in Prostate Cancer (clinicaltrials.gov) -  Apr 15, 2012
P2, N=36, Active, not recruiting,  Sponsor: Duke University
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting

|||||||||| Enrollment change: ATIVR: Using Telephone Technology to Prevent Relapse After Alcoholism Treatment (clinicaltrials.gov) - Apr 8, 2012
P2, N=158, Completed, Sponsor: University of Vermont
Recruiting --> Active, not recruiting N=200 --> 158

|||||||||| Trial completion: ATIVR: Using Telephone Technology to Prevent Relapse After Alcoholism Treatment (clinicaltrials.gov) - Apr 8, 2012
P2, N=158, Completed, Sponsor: University of Vermont
N=200 --> 158 Recruiting --> Completed

|||||||||| Enrollment closed, Surgery: Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC (clinicaltrials.gov) - Apr 4, 2012
P4, N=100, Active, not recruiting, Sponsor: Kyoto University
Recruiting --> Completed Recruiting --> Active, not recruiting

|||||||||| Trial completion: OPTIMEV: Epidemiology of Thromboembolism Disease: A Cohort Study (clinicaltrials.gov) - Apr 4, 2012
P=N/A, N=8256, Completed, Sponsor: University Hospital, Grenoble
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

|||||||||| New P1 trial: Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians (clinicaltrials.gov) - Apr 2, 2012
P1, N=58, Completed, Sponsor: Ji Xunming

||||||||||  Takecab (vonoprazan) / Takeda, Phathom Pharma
New P3 trial:  A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy (clinicaltrials.gov) -  Mar 29, 2012
P3, N=27, Completed,  Sponsor: Takeda

||||||||||  Takecab (vonoprazan) / Takeda, Phathom Pharma
New P3 trial:  A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) Therapy (clinicaltrials.gov) -  Mar 29, 2012
P3, N=30, Completed,  Sponsor: Takeda

||||||||||  Humira (adalimumab) / Eisai, AbbVie
New P3 trial:  APPRECIA: Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease (clinicaltrials.gov) -  Mar 26, 2012
P3, N=84, Active, not recruiting,  Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

||||||||||  zoledronic acid / Generic mfg.
New P1/2 trial:  Zometa: Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone Zom (clinicaltrials.gov) -  Mar 25, 2012
P1/2, N=24, Terminated,  Sponsor: Nantes University Hospital

|||||||||| Enrollment closed: PseudIgY: Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis (clinicaltrials.gov) - Mar 22, 2012
P1/2, N=20, Active, not recruiting, Sponsor: Immunsystem AB
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  ribavirin / Generic mfg.
New P2 trial, Pre-transplantation, Post-transplantation:  Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant (clinicaltrials.gov) -  Mar 19, 2012
P2, N=50, Active, not recruiting,  Sponsor: Gilead Sciences

|||||||||| Trial withdrawal, Surgery: Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases (clinicaltrials.gov) - Mar 15, 2012
P2, N=0, Withdrawn, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Recruiting --> Withdrawn

|||||||||| Enrollment change, Surgery: Prospective Randomized Trial Evaluating Mandatory Second Look Surgery With HIPEC and CRS vs. Standard of Care in Subjects at High Risk of Developing Colorectal Peritoneal Metastases (clinicaltrials.gov) - Mar 15, 2012
P2, N=0, Withdrawn, Sponsor: National Cancer Institute (NCI)
Recruiting --> Withdrawn N=100 --> 0

||||||||||  filorexant (MK6096) / Merck (MSD)
New P2a trial, Monotherapy:  Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022) (clinicaltrials.gov) -  Mar 12, 2012
P2a, N=129, Terminated,  Sponsor: Merck

||||||||||  Flynpovi (eflornithine/sulindac) / Panbela Therap
Trial completion, IO biomarker:  Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps (clinicaltrials.gov) -  Mar 12, 2012
P3, N=150, Completed,  Sponsor: National Cancer Institute (NCI)
N=100 --> 0 Active, not recruiting --> Completed

|||||||||| Enrollment open: SUIVICOL: Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization (clinicaltrials.gov) - Mar 8, 2012
P=N/A, N=300, Recruiting, Sponsor: University Hospital, Bordeaux
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  Multaq (dronedarone) / Sanofi
Enrollment change:  ELECTRAt: Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA) (clinicaltrials.gov) -  Mar 6, 2012
P4, N=292, Completed,  Sponsor: Sanofi
Not yet recruiting --> Recruiting N=500 --> 292

||||||||||  Multaq (dronedarone) / Sanofi
Trial completion:  ELECTRAt: Dronedarone Pattern of Use in Patients Scheduled for Elective Cardioversion (ELECTRA) (clinicaltrials.gov) -  Mar 6, 2012
P4, N=292, Completed,  Sponsor: Sanofi
N=500 --> 292 Active, not recruiting --> Completed

||||||||||  everolimus / Generic mfg.
New P1 trial:  Phase 1 Trial of the Mammalian Target of Rapamycin (mTOR) Inhibitor Everolimus Plus Radiation Therapy (RT) for Salvage Treatment of Biochemical Recurrence in Prostate Cancer Patients Following Prostatectomy (clinicaltrials.gov) -  Mar 6, 2012
P1, N=33, Recruiting,  Sponsor: Abramson Cancer Center of the University of Pennsylvania

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial initiation date:  Rituximab to Prevent Recurrence of Proteinuria (clinicaltrials.gov) -  Mar 5, 2012
P2/3, N=40, Recruiting,  Sponsor: University of Miami
Active, not recruiting --> Completed Initiation date: Aug 2010 --> Mar 2012

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Enrollment open:  Rituximab to Prevent Recurrence of Proteinuria (clinicaltrials.gov) -  Mar 5, 2012
P2/3, N=40, Recruiting,  Sponsor: University of Miami
Initiation date: Aug 2010 --> Mar 2012 Not yet recruiting --> Recruiting

|||||||||| Enrollment open: Monitor-AF;EPEUHM: Management of New-Onset Postoperative Atrial Fibrillation (clinicaltrials.gov) - Mar 4, 2012
P=N/A, N=50, Recruiting, Sponsor: Emory University
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

||||||||||  carboplatin / Generic mfg., pemetrexed / Generic mfg.
Trial completion:  Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) -  Feb 23, 2012
P2, N=44, Completed,  Sponsor: Dana-Farber Cancer Institute
Not yet recruiting --> Recruiting Active, not recruiting --> Completed

||||||||||  entecavir / Generic mfg., emtricitabine/tenofovir disoproxil fumarate / Generic mfg.
Trial completion, Post-transplantation:  Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease. (clinicaltrials.gov) -  Feb 21, 2012
P2, N=112, Completed,  Sponsor: Gilead Sciences
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Clinical: Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy (clinicaltrials.gov) - Feb 9, 2012
P=N/A, N=402, Active, not recruiting, Sponsor: Centre for the AIDS Programme of Research in South Africa

||||||||||  eplerenone / Generic mfg.
Trial termination:  EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion (clinicaltrials.gov) -  Feb 8, 2012
P2, N=38, Terminated,  Sponsor: University Hospital, Saarland
Recruiting --> Terminated; Inclusion rate too low. Recruitment of further study centers too costly.

||||||||||  eplerenone / Generic mfg.
Enrollment change:  EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion (clinicaltrials.gov) -  Feb 8, 2012
P2, N=38, Terminated,  Sponsor: University Hospital, Saarland
Recruitment of further study centers too costly. N=220 --> 38

||||||||||  cisplatin / Generic mfg.
Trial termination:  Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk (clinicaltrials.gov) -  Feb 8, 2012
P2, N=10, Terminated,  Sponsor: Chang Gung Memorial Hospital
Recruiting --> Terminated; Study group showed better results. Poor Accrual.

||||||||||  cisplatin / Generic mfg.
Enrollment change:  Postoperative Concurrent Chemoradiation for Head and Neck Cancer With Multiple Minor Risk (clinicaltrials.gov) -  Feb 8, 2012
P2, N=10, Terminated,  Sponsor: Chang Gung Memorial Hospital
Poor Accrual. N=50 --> 10

|||||||||| New P2 trial, Surgery, Biopsy: Neoadjuvant Chemohormonal Therapy Followed by Salvage Surgery for High Risk PSA (clinicaltrials.gov) - Feb 8, 2012
P2, N=2, Completed, Sponsor: H. Lee Moffitt Cancer Center and Research Institute

||||||||||  Legalon (silibinin) / Viatris
New P2 trial:  Legalon SIL for the Treatment of HCV Recurrence in Liver Transplanted Patients (clinicaltrials.gov) -  Feb 6, 2012
P2, N=14, Terminated,  Sponsor: Rottapharm



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