Clinical trial NCT02791269: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
timeFrame: End of 24-weeks follow-up (Week 72)
measure: Number of Participants With HBV-DNA <20,000 Copies/mL
timeFrame: End of 24-weeks follow-up (Week 72)
Secondary outcomes:
measure: Number of Participants With HBV-DNA <400 Copies/mL
timeFrame: Week 48 (end of treatment) and Week 72 (end of follow-up)
measure: Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
timeFrame: Week 48 (end of treatment) and Week 72 (end of follow-up)
measure: Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
timeFrame: Week 48 (end of treatment) and Week 72 (end of follow-up)
measure: Number of Participants With HBeAg Seroconversion
timeFrame: Week 48 (end of treatment) and Week 72 (end of follow-up)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: New Plymouth
country: New Zealand
city: Riccarton, Christchurch
country: New Zealand
city: Rotorua
country: New Zealand
city: Whangarei
country: New Zealand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: