3-year Follow-up Study in Patients Previously Treated With a TMC435 for the Treatment of Hepatitis C Virus (HCV) Infection

Hepatitis C Clinical Trial

Official title:

A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349465
• Other study ID #: CR017365
• Secondary ID: TMC435HPC3002201
• Status: Completed
• Phase: Phase 3
• First received: April 26, 2011
• Last updated: January 19, 2016
• Start date: July 2011
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Janssen R&D Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationUnited States: Food and Drug AdministrationCanada: Ethics Review CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate TMC435 for the treatment of chronic hepatitis C virus (HCV) infection.

Description:

This is a 3-year follow-up study in patients who completed a previous Phase II or III study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each participant will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last planned visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have previously participated in a Phase II or Phase III study

• Must have received at least one dose of TMC435 in that study

• Has completed the last patient visit of the previous study

Exclusion Criteria:

• Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device

• Have received antiviral or immunomodulating treatment for hepatitis C virus (HCV) between last visit previous study and this study

Study Design

N/A

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• No treatment
No treatment was given as this is an observational study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen R&D Ireland

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who achieved sustained virologic response (SVR) at the last visit of previous study	The SVR is measured by the number of patients with undetectable hepatitis C virus (HCV) RNA(ribonucleic acid) <25 IU/mL undetectable.	Month 6, Month 12, Month 18, Month 24, Month 30, Month 36	No
Primary	Change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at the last visit of the previous study		Month 6, Month 12, Month 18, Month 24, Month 30, Month 36	No
Secondary	Change in sequence of the HCV NS3/4A region in patients with late relapse	The late relapse is defined as the relapse after the last visit of the previous study.	Month 6, Month 12, Month 18, Month 24, Month 30, Month 36	No
Secondary	Assessment of development of liver disease progression in patients previously treated with a TMC435-containing regimen	Child-Pugh score to evaluate hepatic disease progression will be conducted at timepoints.	At screening, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36	No