A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.

Hepatitis B, Chronic Clinical Trial

Official title:

An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00460850
• Other study ID #: ML20135
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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