A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01645969
First received: July 18, 2012
Last updated: July 7, 2014
Last verified: July 2014

July 18, 2012
July 7, 2014
April 2011
October 2012   (final data collection date for primary outcome measure)
Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01645969 on ClinicalTrials.gov Archive Site
Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265
A Follow-up Study to Evaluate the One-year Post Treatment Effects of Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study ML 22265

This multicenter, prospective, observational study will evaluate the one-year ou tcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys ( peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from ea ch patient for up to one year post-therapy.

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

Patients who received treatment and completed follow-up in study arm "A" of study ML22265

Hepatitis B, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point

Exclusion Criteria:

  • Patients unwilling to provide informed consent or abide by the requirements of the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01645969
ML25647
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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