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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791269
• Other study ID #: ML19295
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2016
• Last updated: June 23, 2016
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period. Total length of the study is anticipated to be approximately 72 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• HBV-deoxy ribonucleic acid (DNA) more than 100,000 copies per milliliter (copies/mL) as determined by polymerase chain reaction (PCR)

• 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 (x) of ULN

• HBeAg positive participants: HBV DNA > 500,000 copies/mL, HBeAg negative participants: HBV DNA >100,000 copies/mL by 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 oesophageal 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 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
HBeAg positive and HBeAg negative participants will receive peginterferon alfa-2a 180 mcg subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HBeAg positive participants with HBV-DNA less than (<) 100,000 copies/mL as determined by Roche PCR or Taqman tests		End of 24-weeks follow-up (Week 72)	No
Primary	Number of HBeAg negative participants with HBV-DNA <20,000 copies/mL as determined by Roche PCR or Taqman tests		End of 24-weeks follow-up (Week 72)	No
Secondary	Number of participants with HBV-DNA <400 copies/mL as determined by Roche PCR or Taqman tests		Weeks 48 (end of treatment) and 72 (end of follow-up)	No
Secondary	Number of participants with HBsAg seroconversion (HBsAg negative and anti-HBs positive)		Weeks 48 (end of treatment) and 72 (end of follow-up)	No
Secondary	Number of participants with normal ALT levels		Weeks 48 (end of treatment) and 72 (end of follow-up)	No
Secondary	Number of participants with HBeAg seroconversion (HBeAg negative and hepatitis B e antibody [anti-HBe] positive)		Weeks 48 (end of treatment) and 72 (end of follow-up)	No
Secondary	Number of participants with adverse events (AEs) and serious adverse events (SAEs)		Baseline up to end of follow-up period (Approximately 72 weeks)	No