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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01011738
First received: November 10, 2009
Last updated: December 3, 2012
Last verified: December 2012

November 10, 2009
December 3, 2012
April 2009
April 2015   (final data collection date for primary outcome measure)
HBsAg clearance [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011738 on ClinicalTrials.gov Archive Site
  • suppression of HBV DNA, HBeAg seroconversion, quantitative HBsAg, serum ALT [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ]
  • Safety: incidence of CHB-associated clinical endpoints, serious and non-serious adverse drug reactions [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys
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)

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 are followed for up to 5 years. Target sample size is <2500.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with chronic hepatitis C receiving treatment with peginterferon alfa-2a 40KD (Pegasys)

Hepatitis B, Chronic
Drug: peginterferon alfa-2a [Pegasys]
As prescribed by physician
Cohort
Intervention: Drug: peginterferon alfa-2a [Pegasys]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1849
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patient, >/= 18 years of age
  • chronic hepatitis B
  • treatment with peginterferon alfa-2A

Exclusion Criteria:

  • coinfection with HAV, HCV and HIV
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT01011738
MV22009
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP