A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

December 13, 2016 updated by: Hoffmann-La Roche

Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) in Patients With HBeAg-Positive And HBeAg-Negative Chronic Hepatitis B

This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
      • Hamilton, New Zealand
      • New Plymouth, New Zealand
      • Riccarton, Christchurch, New Zealand, 8011
      • Rotorua, New Zealand
      • Whangarei, New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-cirrhotic participants
  • Hepatitis B surface antigen (HBsAg) positive for at least 6 months
  • Hepatitis B surface antibody (anti-HBs) negative
  • Elevated serum alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) but less than or equal to (</=) 10 times of ULN
  • HBeAg positive participants: HBV DNA > 500,000 copies/mL, HBeAg negative participants: HBV DNA >100,000 copies/mL by polymerase chain reaction (PCR)
  • Participants with chronic hepatitis B (CHB) who are treatment-naive
  • No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a nucleoside analogue
  • For women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. Willingness to use reliable contraception during the study and for 3 months after treatment completion

Exclusion Criteria:

  • Previous antiviral or IFN-based therapy for CHB before enrolment
  • Pregnant or breast feeding women participants
  • Evidence of decompensated liver disease
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
  • History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
  • Previous or current hepatocellular carcinoma
  • History of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Alpha-fetoprotein levels of >100 nanograms (ng)/mL
  • Severe psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study
  • Thyroid disease uncontrolled by prescribed medications
  • Evidence of severe retinopathy
  • Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HBeAg Negative Participants
HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Drug: Peginterferon alfa-2a
180 mcg SC injection QW for 48 weeks.
Other Names:
  • Pegasys
Experimental: HBeAg Positive Participants
HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Drug: Peginterferon alfa-2a
180 mcg SC injection QW for 48 weeks.
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
Time Frame: End of 24-weeks follow-up (Week 72)
HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
End of 24-weeks follow-up (Week 72)
Number of Participants With HBV-DNA <20,000 Copies/mL
Time Frame: End of 24-weeks follow-up (Week 72)
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
End of 24-weeks follow-up (Week 72)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With HBV-DNA <400 Copies/mL
Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.
Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).
Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With HBeAg Seroconversion
Time Frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).
Week 48 (end of treatment) and Week 72 (end of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19295

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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