Clinical trial NCT00927082: A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Official title: A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-06-24
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* Informed consent for Study WV19432
* Patients who have completed treatment and follow-up on study WV19432

Exclusion Criteria:

* As for Study WV19432

Primary outcomes:
measure: Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With HBsAg Loss
timeFrame: Annually, for up to 5 years
Secondary outcomes:
measure: Percentage of Participants With HBeAg Loss.
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Presence of Anti-HBs
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Normalised Alanine Transaminase (ALT)
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
timeFrame: Annually, for up to 5 years
measure: Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
timeFrame: Annually, for up to 5 years
measure: Quantitative HBsAg
timeFrame: Annually, for up to 5 years
measure: Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
timeFrame: Up to 5-year FU period
measure: Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
timeFrame: Up to 5-year FU period
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Up to 5-year FU period
Other outcomes:
Locations:
city: Fitzroy
country: Australia
state: Victoria
city: Salvador
country: Brazil
state: BA
city: Campinas
country: Brazil
state: SP
city: Ribeirao Preto
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Beijing
country: China
city: Beijing
country: China
city: Changsha
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Singapore
country: Singapore
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
city: Songkhla
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: