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Completed

NCT Number: NCT02791269

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

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a

Drug

180 mcg SC injection QW for 48 weeks.

Other names: Pegasys

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2016
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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