Clinical trial NCT00487747: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
Official title: PEGASYS® (Peginterferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative 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: 2007-06-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age;
* chronic hepatitis B;
* Hepatitis B Virus (HBV) DNA \>100,000 copies/mL.

Exclusion Criteria:

* previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
* evidence of decompensated liver disease;
* history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
* coinfection with hepatitis A, C or D, or HIV.

Primary outcomes:
measure: Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
timeFrame: Week 96
measure: Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
timeFrame: Week 96
Secondary outcomes:
measure: Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
timeFrame: Week 96
measure: Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
timeFrame: Week 96
measure: Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
timeFrame: Up to Week 96
measure: Mean Change in Laboratory Parameters (ALT Levels)
timeFrame: From Screening (Day 0) to Week 96
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novokuznetsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Rostov-na-donu
country: Russian Federation
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tumen
country: Russian Federation
city: UFA
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Yakutsk
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: