A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNa-2a and ribavirin in HCV genotype 1 infected subjects who failed to respond or relapsed following at least 1 course of PegIFNa-2a/b and RBV therapy. - ASPIRE (i.e. Antiviral Stat-C Protease Inhibitor Regimen in Experienced subjects)

Tibotec Pharmaceuticals0 sites455 target enrollmentAugust 19, 2009

Overview

No summary available.

Registry

who.int

Start Date

August 19, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects who meet all of the following criteria are eligible for this trial:
•1\. Male or female subject aged between 18 and 70 years, extremes included;
•2\. Documented chronic hepatitis C infection as evidenced by all of the following:
•\- a liver biopsy demonstrating chronic viral hepatitis within 2 years of screening;
•\- anti\-HCV positive;
•\- HCV RNA positive (if only inflammation is present on liver biopsy, HCV RNA presence
•should be documented for at least 6 months prior to baseline).
•Note: If no biopsy is available, one will be performed on a separate day during screening. For subjects with cirrhosis diagnosed by prior biopsy (evidence of which should be available in the source documents) and no evidence of hepatocellular carcinoma (confirmed by alpha\-fetoprotein \[AFP] level \< 50 ng/mL and ultrasound at screening), another biopsy is not required.
•3\. Genotype 1 HCV infection (confirmed at screening);
•4\. Plasma HCV RNA of \> 10,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay);

•Subjects meeting 1 or more of the following criteria cannot be selected:
•1\. Decompensated liver disease defined as history or presence of ascites, hepatic encephalopathy, esophageal bleeding, or gastric varices.
•2\. Any other liver disease of non\-HCV etiology; this may include but is not limited to hepatitis A or B, drug\- or alcohol\-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson’s disease, non\-alcoholic steatohepatitis (NASH) or primary biliary cirrhosis;
•3\. Infection/co\-infection with non\-genotype 1 HCV;
•4\. Co\-infection with HIV type 1 or type 2 (HIV\-1 or HIV\-2\) (positive HIV\-1 or HIV\-2 antibodies test at screening) or hepatitis B virus infection (hepatitis B surface antigen
•5\. History of invasive malignancy diagnosed or treated within 5 years prior to screening (locally treated non\-invasive basal cell skin carcinoma is permitted; cervical carcinoma in situ is allowed if treated prior to screening);
•6\. Evidence of hepatocellular carcinoma (e.g., AFP \> 50 ng/mL);
•7\. Medical conditions that are exclusion criteria for PegIFNa\-2a or RBV treatment (please refer to the manufacturer’s prescribing information for details):
•\- Presence or history of psychiatric disorders including but not limited to severe depression, anxiety disorders, psychotic disorders, a history of hospitalization for
•any psychiatric disorder or a suicide attempt;