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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:
ClinicalTrials.gov Identifier:
NCT01645969
First Posted: July 20, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT) [ Time Frame: 1 year ]

Enrollment: 65
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who received treatment and completed follow-up in study arm "A" of study ML22265
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645969


Locations
China
Changsha, China, 410008
Fu Zhou, China, 350005
Guangzhou, China, 510515
Wuhan, China, 430030
Xi'an, China, 710038
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01645969     History of Changes
Other Study ID Numbers: ML25647
First Submitted: July 18, 2012
First Posted: July 20, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs