A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies

Hepatitis B, Chronic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962975
• Other study ID #: PP22612
• Status: Completed
• Phase: Phase 1
• First received: August 19, 2009
• Last updated: April 7, 2014
• Start date: September 2009
• Est. completion date: May 2013

Study information

• Verified date: April 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health Research Council
• Study type: Interventional

Clinical Trial Summary

In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is <100.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >/=18 years of age

• previous participation in other donor protocol

• chronic hepatitis B

• no other anti-HBV treatment after completion of previous donor protocol

• female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study

Exclusion Criteria:

• hepatic decompensation (Child-Pugh class B and C)

• antiviral, antineoplastic or immunomodulatory treatment

• evidence of alcohol and/or drug abuse

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 B
• Hepatitis B, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  New Zealand,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA		assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up	No
Secondary	Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications		assessed every 2 months on treatment and up to week 24 of follow-up	No