Navigation Links
Tibotec Starts Global Phase 3 Clinical Trials Studying TMC435 in Adults With Chronic Genotype 1 HCV
Date:2/18/2011

patients in this trial will either receive peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®) as part of their treatment. A third global, phase 3, double-blind randomized study, known as TMC435-C3007 or PROMISE (PROtease inhibitor TMC435 In PatientS who have previously rElapsed on IFN/RBV), will evaluate a single TMC435 once-daily oral tablet (150 mg) verses placebo in HCV patients who experienced viral relapse after previous interferon-based therapy. Both groups will receive peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®). The complete treatment duration for all three trials will be 24 or 48 weeks, depending on patient response.

The studies will be conducted at more than 160 sites in 24 countries, including the U.S. and countries throughout Europe, and together seek to enroll approximately 1,125 HCV genotype 1 infected patients who are treatment-naive or have experienced a relapse after previous interferon-based HCV therapy. To be eligible, patients must have chronic hepatitis C infection, and must have had a liver biopsy within three years of the screening visit. For those patients who have not had a liver biopsy in the three years prior to the study, one will be performed before the baseline visit. In addition, eligible patients need to have completed a recent ultrasound with no findings suspicious of hepatocellular carcinoma (HCC). Patients with signs of hepatic decompensation, liver disease of any non-HCV etiology, co-infection with hepatitis B or HIV-1 and 2 or a history of malignancy within 5 years of the screening vitis are ineligible for the study. Patients in QUEST-1 and QUEST-2 trials must not have received any prior treatment for hepatitis C, and patients in the PROMISE trial must have previously received at least 24 weeks of (peg)interferon-based therapy, along with documented negative HCV RNA at last o
'/>"/>

SOURCE Tibotec Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
2. Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV
3. Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008
4. Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008
5. Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds
6. Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
7. Tibotec Therapeutics Launches GRACE Campaign for Women and People of Color Living With HIV/AIDS
8. Tibotec Therapeutics Debuts Innovative Web Portal for HIV/AIDS Front-Line Service Providers
9. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
10. Medivir Notes That Partner Tibotec Announced Week 24 Interim Results From Phase 2b TMC435 PILLAR Study to be Presented as a Late-Breaker at AASLD
11. Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/28/2014)... Chinese magnesium alloy maker DongGuan Eontec Co., ... alloy bone fixation screw has received Chinese regulatory inspection ... instrument and that the company acknowledges receipt of the ... Science and Technology Daily journalists Wang Xiangming and ... founder, Professor Li Yangde , has been a ...
(Date:11/27/2014)... 27, 2014 Hovione announced today ... Application with the U.S. Food and Drug Administration (FDA). ... developing improved drug delivery options for established drugs. ... novel formulation using a new patented crystalline base form ... widely prescribed oral antibiotics for acne. Currently, there are ...
(Date:11/26/2014)... 2014   Royal Philips (NYSE: ... availability of its portfolio of diagnostic X-ray ... Opta[i] , ProGrade and PrimaryDiagnost[ii]. With new releases ... the U.S., and availability of all these solutions ... customers innovative solutions designed to meet the needs ...
Breaking Medicine Technology:Chinese magnesium alloy manufacturer Eontec expects to have its medical magnesium alloy available for clinical trial in 2015 2Chinese magnesium alloy manufacturer Eontec expects to have its medical magnesium alloy available for clinical trial in 2015 3Chinese magnesium alloy manufacturer Eontec expects to have its medical magnesium alloy available for clinical trial in 2015 4Hovione Files its First Investigational New Drug Application With the FDA 2Philips expands global reach of diagnostic X-Ray solutions 2Philips expands global reach of diagnostic X-Ray solutions 3
(Date:11/28/2014)... -- Planning on seconds at Thanksgiving Day dinner this ... as gastroesophageal reflux disease (GERD) -- a few steps may ... nose and throat specialist at Lenox Hill Hospital in New ... on Thanksgiving: Pace yourself. Rather than ... throughout the day. It,s also a good idea to have ...
(Date:11/28/2014)... Austin, Texas (PRWEB) November 28, 2014 ... of prediabetes testing and treatment, helped employees learn ... complimentary on-site diabetes blood screening at a local ... Stop Diabetes @ Work initiative. , As ... @ Work program , PreDiabetes Centers is co-hosting ...
(Date:11/28/2014)... 2014 Mabel’s Labels , the ... and an award-winning company established by four moms, today ... and Tricia Mumby have been honored with a 2014 ... the PROFIT Award for Excellence in Entrepreneurship. , All ... Tricia Mumby) accepted the award on behalf of Mabel’s ...
(Date:11/28/2014)... UniWigs.com, a leader in the wig industry, has ... the next Monday. This promotion features: , > ... up to 70% off (no coupon code needed), ... shipping on orders over $49 , Visit http://www.uniwigs.com for ... Nov. 28th to Dec. 1st and the first 100 shoppers each ...
(Date:11/28/2014)... (PRWEB) November 28, 2014 "Most of my ... me to use crutches," said an inventor from Findlay, Ohio. ... convenient way to support my foot, which inspired me to ... to offer a convenient way to support an injured foot. ... around. It eliminates the need for crutches. The design redistributes ...
Breaking Medicine News(10 mins):Health News:Don't Let Chronic Heartburn Spoil Your Thanksgiving Feast 2Health News:PreDiabetes Centers Offers Workplace Diabetes Screening at Local School 2Health News:Mabel's Labels’ Co-Founders Named A Winner In The 2014 RBC Canadian Women Entrepreneur Awards Program; A Second-Time Win For The Brand 2Health News:Mabel's Labels’ Co-Founders Named A Winner In The 2014 RBC Canadian Women Entrepreneur Awards Program; A Second-Time Win For The Brand 3Health News:Pre-X'mas Crazy Sale Starts from $0 at UniWigs.com 2
... 28 A few spaces remain for the U.S. ... on Nov. 4-5, 2009. , (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) ... and journalists and will focus on how FDA employs ... This year,s symposium will feature an address by FDA ...
... inflammatory diseases, researchers say , WEDNESDAY, Oct. 28 (HealthDay ... that fish oils benefit people with rheumatoid arthritis and ... an ingredient in fish oils called DHA into a ... can lead to various diseases, the scientists from Queen ...
... get a boo-boo, we might know to put a bandage on ... it all better. But, what if something happens to our ... for dental emergencies can quickly get back to smiling again. , ... http://inr.mediaseed.tv/oneClip_C/?feed=Ss8P5Rb1iQulYDAELUR0M_kpwKp_6YSM , Medialink is a division of ...
... , What Women Want, Think Should Be Done and at ... new poll released Wednesday by the Independent Women,s Forum ... should be Congress,s top priority and that a majority (51 percent) ... the proposals being considered today. The poll, conducted by WomanTrend, ...
... Collagen Matrix, Inc., the leader in collagen- and mineral-based ... Company,s Founder, President, and Chief Executive Officer was named ... Year category of the 2009 New Jersey Business of ... Certified Public Accountants and Consultants. All finalists will ...
... 28 Atlanta-based Webmedx , the fourth ... of black market sales of medical records in India as ... most reliable way to maintain standards of privacy and security. ... stringent rules for protected health information, the onus on transcription ...
Cached Medicine News:Health News:New Clues to How Fish Oils Help Arthritis Patients 2Health News:Just Released -- New Poll: Healthcare Through Women's Eyes 2Health News:Shu-Tung Li, Founder and CEO of Collagen Matrix, Inc. Honored as 2009 New Jersey Executive of the Year Finalist and Company Named One of Fifty Fastest Growing Companies 2Health News:Webmedx Reacts to News of Confidential Medical Records Being Sold on the Black Market 2
... The automated solution for Western Blot analysis ... a fully automated Western Blot Analyzer for ... that reveal the presence of infectious diseases ... enables fast and accurate screening of allergies ...
... Advantages of using the Antigen-Antibody Pens-Using ... designed and developed specialized fountain pens, called ... deliver or write/mark the blotting membranes in ... specially formulated antigen-bonded colored dyes helps to ...
... of pure water, Complete, Compact Systems for ... compact S.D.S. Storage and Distribution Systems are ... of purified water produced by Elix or ... of stored water, provide effective protection against ...
... Liters of pure water, Complete, Compact Systems ... Water,Millipores compact S.D.S. Storage and Distribution Systems ... liters of purified water produced by Elix ... purity of stored water, provide effective protection ...
Medicine Products: