An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT01886300
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment 6 months A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to \<2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.
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 12 months HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period Up to 24 months A participant was considered to have achieved suppression of HBV DNA to \<2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.
Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period Up to 24 months HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to \<2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.
Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period Up to 24 months Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit.
Number of Participants With Incidence of Adverse Events Up to 24 months An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product
Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period Up to 24 months HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.
Incidence of Normalization of Serum Alanine Transaminase Up to 24 months Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.