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

Hepatitis B, Chronic Clinical Trial

Official title:

A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating Sustained Response in Subjects With HBeAg Positive Chronic Hepatitis B Receiving Therapy With Pegasys (Peginterferon Alfa-2a) in Vietnam

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01886300
• Other study ID #: ML27807
• Status: Terminated
• Phase: N/A
• First received: June 21, 2013
• Last updated: November 2, 2015
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health - Department of Scientific Technology and Training
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained off-treatment response rate (based on HBeAg seroconversion) at 6 months after the end of treatment		approximately 2.5 years	No
Primary	Sustained off-treatment response rate (based on HBeAg seroconversion) at 12 months after the end of treatment		approximately 2.5 years	No
Secondary	Percentage of patients with suppression of HBV DNA to < 2,000 IU/mL during the observation period		approximately 2 years	No
Secondary	Incidence of HBsAg clearance		approximately 2 years	No
Secondary	Incidence of normalization of serum ALT		approximately 2 years	No