Clinical trial NCT00922207: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Official title: A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age;
* HBeAg+ve for \>=3 months;
* positive serum HBV DNA within 3 months prior to entry;
* patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
* \>=3 months treatment-free interval from nucleotide analogues.

Exclusion Criteria:

* evidence of decompensated liver disease;
* history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
* co-infection with active hepatitis A,C or D, or HIV.

Primary outcomes:
measure: Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
timeFrame: Week 100
Secondary outcomes:
measure: Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
timeFrame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
measure: Percentage of Participants Who Were HBeAg Negative
timeFrame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
measure: Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
timeFrame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
measure: Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
timeFrame: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
measure: Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
timeFrame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
measure: Percentage of Participants With Combined Response
timeFrame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Internal Medicine
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
city: Keelung City
country: Taiwan
facility: Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
city: Taichung
country: Taiwan
facility: China Medical University Hospital; Department of Rheumatology
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Gastro-Enterology Dept.
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Gastroenterology Division
city: Taipei
country: Taiwan
facility: Tri-Service Hospital; Dept. of Internal Medicine
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: