Click Here For Trial Information; TMC435HPC3007 - Phase III Trial of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
This study is currently recruiting participants.
Locations
United States, California
Recruiting
Bakersfield, California, United States
Not yet recruiting
Los Angeles, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
United States, Florida
Recruiting
Jacksonville, Florida, United States
Recruiting
Orlando, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Kentucky
Recruiting
Florence, Kentucky, United States
United States, Minnesota
Recruiting
Saint Paul, Minnesota, United States
United States, Mississippi
Recruiting
Jackson, Mississippi, United States
United States, Tennessee
Recruiting
Germantown, Tennessee, United States
United States, Texas
Recruiting
Houston, Texas, United States
Recruiting
San Antonio, Texas, United States
Australia
Not yet recruiting
Adelaide, Australia
Not yet recruiting
Kingswood, Australia
Not yet recruiting
Melbourne, Australia
Not yet recruiting
Sydney, Australia
Not yet recruiting
Woolloongabba N/A, Australia
Austria
Recruiting
Wien, Austria
Not yet recruiting
Wien, Austria
Belgium
Recruiting
Antwerpen, Belgium
Recruiting
Brugge, Belgium
Not yet recruiting
Brussel, Belgium
Recruiting
Brussels, Belgium
Not yet recruiting
Gent, Belgium
Not yet recruiting
Leuven, Belgium
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Not yet recruiting
Ottawa, Ontario, Canada
Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada
France
Not yet recruiting
Creteil N/A, France
Recruiting
Grenoble, France
Not yet recruiting
Lyon, France
Recruiting
Nice N/A, France
Not yet recruiting
Paris, France
Not yet recruiting
Paris Cedex 12, France
Not yet recruiting
Rennes Cedex, France
Not yet recruiting
Vandoeuvre Les Nancy, France
Germany
Recruiting
Berlin, Germany
Recruiting
Düsseldorf, Germany
Not yet recruiting
Frankfurt, Germany
Recruiting
Freiburg, Germany
Not yet recruiting
Halle (Saale), Germany
Recruiting
Hamburg, Germany
Recruiting
Kiel, Germany
Recruiting
Leipzig, Germany
Recruiting
Munchen, Germany
Recruiting
Würzburg, Germany
Israel
Not yet recruiting
Haifa, Israel
Not yet recruiting
Hedera, Israel
Not yet recruiting
Nazareth, Israel
Not yet recruiting
Petah Tikva, Israel
Not yet recruiting
Zefat, Israel
New Zealand
Not yet recruiting
Auckland, New Zealand
Not yet recruiting
Christchurch, New Zealand
Not yet recruiting
Hamilton, New Zealand
Poland
Recruiting
Bialystok, Poland
Recruiting
Bydgoszcz, Poland
Recruiting
Czeladz, Poland
Recruiting
Kielce, Poland
Recruiting
Krakow, Poland
Recruiting
Warszawa, Poland
Puerto Rico
Not yet recruiting
Ponce Pr, Puerto Rico
Recruiting
San Juan, Puerto Rico
Russian Federation
Not yet recruiting
Ekaterinbourg, Russian Federation
Not yet recruiting
Moscow, Russian Federation
Not yet recruiting
Saint-Petersburg, Russian Federation
Not yet recruiting
Samara, Russian Federation
Not yet recruiting
Smolensk, Russian Federation
Not yet recruiting
St Petersburg, Russian Federation
Not yet recruiting
Stavropol, Russian Federation
Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Recruiting
Sevilla N/A, Spain
Recruiting
Valencia, Spain
United Kingdom
Recruiting
Birmingham, United Kingdom
Not yet recruiting
Derby, United Kingdom
Recruiting
Glasgow, United Kingdom
Not yet recruiting
London, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Plymouth, United Kingdom
Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Press Release;
Medivir - The Phase 3 Program for TMC435 in Treatment-Naive Patients and Patients who Have Relapsed After Prior Interferon-Based Treatment
HUDDINGE, Sweden, February 18, 2011/PRNewswire-FirstCall/ --
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, announced today that the global phase 3 studies with TMC435 in treatment-naive patients and patients who have relapsed after prior SOC treatment have started.
Phase 3 Program in brief:
- TMC435-C208 or QUEST-1 includes approximately 375 treatment-naive
patients
- TMC435-C216 or QUEST-2 includes approximately 375 treatment-naive
patients
- TMC435-C3007 or PROMISE includes approximately 375 who have
relapsed after prior interferon-based treatment
Medivir's CEO, Ron Long,
"This is a momentous and important step for both the project and for Medivir as a company. It is impressive to see Tibotec's diligence and enterprise in developing TMC435 in a time-effective and thorough fashion."
The phase 3 milestone of Euro 5 million flagged in February 2010 will now be recognized as income in the first quarter 2011.
Tibotec released today the following statement:
Cork, Ireland, February 17, 2011 - Tibotec Pharmaceuticals announced today that two global, registrational phase 3 trials are recruiting patients to examine TMC435, its investigational hepatitis C protease inhibitor, in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global phase 3 trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment.
Approximately 3.2 million people in the U.S. live with chronic hepatitis C disease and more than 170 million people have the disease globally.[i],[ii] The response-guided trials will compare the efficacy, safety and tolerability of TMC435 given as a single 150 mg oral tablet once daily for 12 weeks versus placebo; each patient also will be treated with a background regimen of peginterferon and ribavirin for 24 or 48 weeks.
"TMC435 is an important component of our growing HCV pipeline said Brian Woodfall M.D., Vice President of Global Clinical Development at Tibotec." "The initiation of the TMC435 phase 3 clinical trial program reinforces our commitment to develop innovative new treatment options that may decrease the duration of treatment for patients with chronic hepatitis C infection."
Three global studies
The first global, phase 3, double-blind, randomized study, known as TMC435-C208 or QUEST-1 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-1), will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. Both groups will also receive peginterferon alfa-2a (Pegasys(R)) and ribavirin (Copegus(R)) as part of their treatment.
The second global, phase 3, double-blind, randomized study, known as TMC435-C216 or QUEST-2 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-2), also will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. However, patients in this trial will either receive peginterferon alfa-2a (Pegasys(R)) and ribavirin (Copegus(R)) or peginterferon alfa-2b (PegIntron(R)) and ribavirin (Rebetol(R)) 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(R)) and ribavirin (Copegus(R)). The complete treatment duration for all three trials will be 24 or 48 weeks, depending on patient response.
In parallel to these trials phase 3 studies for TMC435 have also recently been launched in Japan. ...
Centers and inclusion criteria's
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 visits 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 on-treatment measurement, and have relapsed (detectable HCV RNA) within one year of last taking medication.
The primary endpoint of the studies is to assess whether TMC435 is superior to placebo in achieving sustained virologic reponse (SVR), defined as HCV RNA less then 25 IU/ml undetectable, 24 weeks after the planned end of treatment (SVR 24), with the final analysis being performed after the last patient reaches week 72 of the study. Secondary endpoints include superiority of TMC435 versus placebo at 12 weeks (SVR 12), after planned end of treatment and at week 72 of the study. Evaluations of viral breakthroughs, relapse rates in treatment groups, safety and tolerability also will be assessed.
About TMC435 in other clinical studies
TMC435 is a once-daily (q.d.) protease inhibitor drug jointly developed by Medivir and Tibotec Pharmaceuticals, to treat chronic hepatitis C virus infections.
In parallel to the recent start of the global phase 3-studies, TMC435 is currently in a follow up phase in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. More safety and efficacy data from the phase 2b trials will be presented at scientific meetings later in 2011.
For additional information for these studies, please see http://www.clinicaltrials.gov/
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.
For additional information, please contact Medivir (http://www.medivir.com/ / ) Rein Piir, CFO & VP Investor Relations Mobile: +46-708-537-292 M:Communications Medivir@mcomgroup.com Europe: Mary-Jane Elliott/ Amber Bielecka /Nick Francis +44(0)20-7920-2330 USA: Roland Tomforde +1-212-897-5497
Source: Medivir
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