An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys

Hepatitis B, Chronic Clinical Trial

Official title:

A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011738
• Other study ID #: MV22009
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: November 2, 2015
• Start date: April 2009
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1847
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient, >/= 18 years of age

• chronic hepatitis B

• treatment with peginterferon alfa-2A

Exclusion Criteria:

• coinfection with HAV, HCV and HIV

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Bahrain,  Bangladesh,  Bosnia and Herzegovina,  Bulgaria,  China,  Egypt,  France,  Germany,  Hong Kong,  India,  Indonesia,  Ireland,  Jordan,  Korea, Republic of,  Lebanon,  Macedonia, The Former Yugoslav Republic of,  Morocco,  New Zealand,  Pakistan,  Poland,  Portugal,  Romania,  Saudi Arabia,  Thailand,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBsAg clearance		on treatment and up to 3 years follow-up	No
Secondary	suppression of HBV DNA, HBeAg seroconversion, quantitative HBsAg, serum ALT		on treatment and up to 3 years follow-up	No
Secondary	Safety: incidence of CHB-associated clinical endpoints, serious and non-serious adverse drug reactions		on treatment and up to 3 years follow-up	No