A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

Hepatitis B, Chronic Clinical Trial

Official title:

An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570191
• Other study ID #: ML18092
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: November 1, 2016
• Start date: November 2004
• Est. completion date: February 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult participants 18-70 years of age

• Positive test result for HBsAg for >6 months

• Naive to treatment for HBV

• On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Exclusion Criteria:

• Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)

• Decompensated liver disease

• Hepatocellular cancer

• Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug

• 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
180 uG in 0.5 mL solution administered once 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

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up		72 Weeks	No
Primary	Alanine Transaminase (ALT) Normalization at the End of Follow-Up		72 Weeks	No
Secondary	Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up		72 Weeks	No
Secondary	Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up		72 Weeks	No
Secondary	HBV DNA Suppression <20000 Copies/mL at the End of Treatment		48 Weeks	No
Secondary	Alanine Transaminase (ALT) Normalization at the End of Treatment		48 Weeks	No