Clinical trial NCT01886300: An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-06-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HBeAg-positive chronic hepatitis B treated with Pegasys

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment
timeFrame: 6 months
measure: Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period
timeFrame: Up to 24 months
measure: Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period
timeFrame: Up to 24 months
measure: Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period
timeFrame: Up to 24 months
measure: Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period
timeFrame: Up to 24 months
measure: Incidence of Normalization of Serum Alanine Transaminase
timeFrame: Up to 24 months
measure: Number of Participants With Incidence of Adverse Events
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
city: Ho Chi Minh City
country: Vietnam
city: Hochiminh city
country: Vietnam
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: