An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam

NCT ID: NCT01886300

Last Updated: 2016-06-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-05-31

Brief Summary

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This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis
* Elevated serum ALT \> ULN (upper limit of normal) but \</= 10 x ULN
* Patients with no contra-indications to Pegasys therapy as detailed in the label
* Written informed consent where local regulations allow or require it

Exclusion Criteria

* Patients should not receive concomitant therapy with telbivudine
* Co-infection with hepatitis A, hepatitis B or HIV
* Pregnant or breastfeeding women
* Patients with depression/mental diseases
* Neutrophil at baseline \> 90.000/mm3
* Abnormal T4 or TSH
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hanoi, , Vietnam

Site Status

Ho Chi Minh City, , Vietnam

Site Status

Hochiminh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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ML27807

Identifier Type: -

Identifier Source: org_study_id

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