CLINICAL TRIALS PROFILE FOR INCIVEK

505(b)(2) Clinical Trials for INCIVEK

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01511432 ↗	A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects	Completed	Vertex Pharmaceuticals Incorporated	Phase 1	2012-01-01	The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.

All Clinical Trials for INCIVEK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01355289 ↗	Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501	Completed	Eisai Inc.	Phase 2	2011-11-01	To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.
NCT01459913 ↗	Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype	Terminated	Vertex Pharmaceuticals Incorporated	Phase 3	2011-11-01	The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.
NCT01511432 ↗	A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects	Completed	Vertex Pharmaceuticals Incorporated	Phase 1	2012-01-01	The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
NCT01581138 ↗	VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C	Completed	Vertex Pharmaceuticals Incorporated	Phase 2	2012-07-01	The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
NCT01592006 ↗	Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients	Terminated	University of Chicago	Phase 4	2012-04-01	Patients are being asked to be part of this study because they are a liver transplant recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver transplant patients includes taking two medications called pegylated interferon alfa-2a (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment of HCV. This study will evaluate the safety and efficacy of adding a third drug called telaprevir for the experimental treatment of HCV in liver transplant patients. The combination of Pegasys, ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is specifically not FDA approved for HCV patients who have had a liver transplant. This is because more information is needed about possible drug interactions between telaprevir and cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically part of routine care for transplant patients. Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys and ribavirin for the treatment of HCV. However, these studies did not include adequate information on transplant patients due to the potential drug interactions. The investigators hope to gather more information about the safety and efficacy of telaprevir given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV that is not well controlled with Pegasys and ribavirin alone.
NCT01598090 ↗	Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir	Completed	Bristol-Myers Squibb	Phase 3	2012-06-14	The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Clinical Trial Conditions for INCIVEK

Condition Name

Condition Name for INCIVEK
Intervention	Trials
Hepatitis C	3
Hepatitis C, Chronic	3
Chronic Hepatitis C	2
Thrombocytopenia	1

Condition MeSH

Condition MeSH for INCIVEK
Intervention	Trials
Hepatitis C	11
Hepatitis	10
Hepatitis A	7
Hepatitis C, Chronic	7

Clinical Trial Locations for INCIVEK

Trials by Country

Trials by Country for INCIVEK
Location	Trials
United States	60
Canada	8
Brazil	5
Austria	2
Poland	2

Trials by US State

Trials by US State for INCIVEK
Location	Trials
Texas	6
California	5
Virginia	4
Maryland	3
Georgia	3

Clinical Trial Progress for INCIVEK

Clinical Trial Phase

Clinical Trial Phase for INCIVEK
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for INCIVEK
Clinical Trial Phase	Trials
Completed	6
Terminated	3
Withdrawn	2

Clinical Trial Sponsors for INCIVEK

Sponsor Name

Sponsor Name for INCIVEK
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	5
Santaris Pharma A/S	2
Eisai Inc.	1

Sponsor Type

Sponsor Type for INCIVEK
Sponsor	Trials
Industry	9
Other	4
U.S. Fed	1