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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00460850
Other study ID # ML20135
Secondary ID
Status Terminated
Phase Phase 4
First received April 16, 2007
Last updated June 27, 2008
Start date September 2007
Est. completion date June 2008

Study information

Verified date June 2008
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health General Management of Drugs and Pharmaceutics Ethics Committee.
Study type Interventional

Clinical Trial Summary

This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date June 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- adult patients, 18-65 years of age;

- HBeAg negative chronic hepatitis B;

- treated with lamivudine for >=6 months;

- demonstrated lamivudine resistance;

- compensated liver disease.

Exclusion Criteria:

- severe hepatic dysfunction;

- previous treatment with antivirals other than lamivudine;

- immunosuppressant treatment in past 6 months;

- co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;

- medical condition associated with chronic liver disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Normalization of ALT, and HBV-DNA <10,000 copies/mL Week 96 No
Secondary Normalization of ALT, and HBV-DNA <10,000 copies/mL Weeks 48 and 72 No
Secondary HBsAg loss and anti-HBs seroconversion Weeks 48, 72 and 96 No
Secondary AEs and lab parameters Throughout study No
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