Back to resultsA Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
New Zealand
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HBeAg Negative Participants
HBeAg Positive Participants
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
Number of Participants With HBV-DNA <20,000 Copies/mL
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Secondary Outcome Measures
Number of Participants With HBV-DNA <400 Copies/mL
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
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.
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
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).
Number of Participants With HBeAg Seroconversion
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02791269
Brief Title
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Official Title
Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) in Patients With HBeAg-Positive And HBeAg-Negative Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBeAg Negative Participants
Arm Type
Experimental
Arm Description
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.
Arm Title
HBeAg Positive Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
180 mcg SC injection QW for 48 weeks.
Primary Outcome Measure Information:
Title
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
Description
HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
Time Frame
End of 24-weeks follow-up (Week 72)
Title
Number of Participants With HBV-DNA <20,000 Copies/mL
Description
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Time Frame
End of 24-weeks follow-up (Week 72)
Secondary Outcome Measure Information:
Title
Number of Participants With HBV-DNA <400 Copies/mL
Description
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Time Frame
Week 48 (end of treatment) and Week 72 (end of follow-up)
Title
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
Description
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.
Time Frame
Week 48 (end of treatment) and Week 72 (end of follow-up)
Title
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
Description
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).
Time Frame
Week 48 (end of treatment) and Week 72 (end of follow-up)
Title
Number of Participants With HBeAg Seroconversion
Description
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).
Time Frame
Week 48 (end of treatment) and Week 72 (end of follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Auckland
Country
New Zealand
City
Hamilton
Country
New Zealand
City
New Plymouth
Country
New Zealand
City
Riccarton, Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Rotorua
Country
New Zealand
City
Whangarei
Country
New Zealand
12. IPD Sharing Statement
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A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
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