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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01645969
Other study ID # ML25647
Secondary ID
Status Completed
Phase N/A
First received July 18, 2012
Last updated November 1, 2016
Start date April 2011
Est. completion date October 2012

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

This multicenter, prospective, observational study will evaluate the one-year outcomes 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 each patient for up to one year post-therapy.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment 1 year No
Secondary Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT) 1 year No
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