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DIRECT Trial - interferon alfacon-1 plus ribavirin

DIRECT is a randomized, open-label, phase III investigational research study that will evaluate the safety and efficacy of daily administration of subcutaneous interferon alfacon-1 plus ribavirin versus no treatment in HCV patients who have not responded to previous combination therapy with pegylated interferon alfa plus ribavirin.

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DIRECT Trial - interferon alfacon-1 plus ribavirin | directtrial.com Reviews
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DIRECT is a randomized, open-label, phase III investigational research study that will evaluate the safety and efficacy of daily administration of subcutaneous interferon alfacon-1 plus ribavirin versus no treatment in HCV patients who have not responded to previous combination therapy with pegylated interferon alfa plus ribavirin.
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2 HCV nonresponders
3 hepatitis C nonresponders
4 subcutaneous interferon alfacon-1 plus ribavirin
5 HCV combination therapy
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DIRECT Trial - interferon alfacon-1 plus ribavirin | directtrial.com Reviews

https://directtrial.com

DIRECT is a randomized, open-label, phase III investigational research study that will evaluate the safety and efficacy of daily administration of subcutaneous interferon alfacon-1 plus ribavirin versus no treatment in HCV patients who have not responded to previous combination therapy with pegylated interferon alfa plus ribavirin.

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1

DIRECT Clinical Trial - Information About Hepatitis C

http://www.directtrial.com/sec/hepc_info.html

For specific questions regarding. The DIRECT Trial not addressed. By this website, please fill out. Medical Information Request Form. INFORMATION ABOUT HEPATITIS C. Nearly 4 million Americans are estimated to be infected with the hepatitis C virus (HCV). That is more than 3 times those with HIV/AIDS, more than 5 times those with Parkinson's disease, and more than 10 times those with multiple sclerosis. The American College of Gastroenterology. American Liver Foundation (ALF).

2

DIRECT Clinical Trial - Study Rationale

http://www.directtrial.com/sec/rationale.html

For specific questions regarding. The DIRECT Trial not addressed. By this website, please fill out. Medical Information Request Form. Fewer than 15% of patients respond to retreatment with pegylated interferons (PegIFNs). Preliminary studies suggest that daily dosing of interferon alfacon-1 (CIFN) plus ribavirin (RBV) can achieve improved outcomes. The DIRECT (IRHC-001) trial is designed to study the efficacy and safety of daily interferon alfacon-1 plus RBV in nonresponder patients.

3

DIRECT Clinical Trial - Inclusion/Exclusion Criteria

http://www.directtrial.com/sec/criteria.html

For specific questions regarding. The DIRECT Trial not addressed. By this website, please fill out. Medical Information Request Form. Patients must have been previously treated with the following starting doses:. Ge; 15 µg/kg/week PegIFN alfa-2b. Ge; 180 µg/week PegIFN alfa-2a. Patients will have documented viral nonresponse to past treatment with PegIFN alfa-2a or 2b plus RBV. Viral nonresponse is defined as:. Less than a 2 log. Patients of all genotypes and cirrhotics will be considered for enrollment.

4

DIRECT Clinical Trial - Find a Study Center

http://www.directtrial.com/sec/center.html

For specific questions regarding. The DIRECT Trial not addressed. By this website, please fill out. Medical Information Request Form. FIND A STUDY CENTER. Three Rivers Pharmaceuticals has selected trial sites in North America and the Caribbean for participation in the DIRECT Trial. Please call Brian Murphy at 714-545-0100 x4033 if you cannot find a trial site near you. Not all trial sites are listed below. Los Angeles, CA. Investigator: Tram Tran, MD. Contact Number: (310) 423-2641. San Mateo, CA. Tulane...

5

DIRECT Clinical Trial - Information for Investigators

http://www.directtrial.com/sec/investigators.html

For specific questions regarding. The DIRECT Trial not addressed. By this website, please fill out. Medical Information Request Form. PLEASE READ: Only authorized visitors may enter this section. This section is intended for Trial Investigators only. To access the Investigator section, please enter the login and password below. Have you forgotten your password? Please submit your email address and the login and password will be sent to your email inbox shortly.

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DIRECT Trial - interferon alfacon-1 plus ribavirin

DIRECT trial patients affected by Hurricane Katrina, please contact Brian Murphy at (714) 545-0100 x3750. DIRECT is a randomized, open-label, phase III investigational research study that will evaluate the safety and efficacy of daily administration of subcutaneous interferon alfacon-1 plus ribavirin versus no treatment in HCV patients who have not responded to previous combination therapy with pegylated interferon alfa plus ribavirin. 2010 Three Rivers Pharmaceuticals, LLC Privacy Statement.

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