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CompletedNCT02791269Updated Feb 6, 2017Results posted

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

A Phase 4 interventional study of Peginterferon alfa-2a in Hepatitis B, Chronic, sponsored by Hoffmann-La Roche. Completed at 6 sites in New Zealand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-06.

Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis B, Chronic
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugPeginterferon alfa-2a

    180 mcg SC injection QW for 48 weeks.

    Also known as: Pegasys

06

What researchers measure

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)

    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)

  2. Number of Participants With HBV-DNA <20,000 Copies/mL

    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 outcomes

  1. Number of Participants With HBV-DNA <400 Copies/mL

    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)

  2. 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.

    Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)

  3. 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).

    Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)

  4. 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).

    Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)

07

Results

Posted Feb 6, 2017

Participant flow

Participant flow — Overall Study
MilestoneHBeAg Negative ParticipantsHBeAg Positive Participants
Started420
Completed419
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryNumber 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.

Time frame:
End of 24-weeks follow-up (Week 72)
Reported as:
Number · participants
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)
participantsHBeAg Positive Participants
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)7
PrimaryNumber of Participants With HBV-DNA <20,000 Copies/mL

HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.

Time frame:
End of 24-weeks follow-up (Week 72)
Reported as:
Number · participants
Number of Participants With HBV-DNA <20,000 Copies/mL
participantsHBeAg Negative ParticipantsHBeAg Positive Participants
Number of Participants With HBV-DNA <20,000 Copies/mL03
SecondaryNumber of Participants With HBV-DNA <400 Copies/mL

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)
Reported as:
Number · participants
Number of Participants With HBV-DNA <400 Copies/mL
participantsHBeAg Negative ParticipantsHBeAg Positive Participants
Week 48 (n=4,18)36
Week 72 (n=3,17)02
SecondaryNumber 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.

Time frame:
Week 48 (end of treatment) and Week 72 (end of follow-up)
Reported as:
Number · participants
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
participantsHBeAg Negative ParticipantsHBeAg Positive Participants
Week 48 (n=4,15)00
Week 72 (n=4,13)00
SecondaryNumber 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).

Time frame:
Week 48 (end of treatment) and Week 72 (end of follow-up)
Reported as:
Number · participants
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
participantsHBeAg Negative ParticipantsHBeAg Positive Participants
Week 48 (n=4,19)24
Week 72 (n=4,17)47
SecondaryNumber 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).

Time frame:
Week 48 (end of treatment) and Week 72 (end of follow-up)
Reported as:
Number · participants
Number of Participants With HBeAg Seroconversion
participantsHBeAg Positive Participants
Week 48 (n=19)6
Week 72 (n=17)6

Adverse events

Collected over Baseline up to end of follow-up period (Approximately 72 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HBeAg Negative Participants—1/4 (25%)3/4 (75%)
HBeAg Positive Participants—0/20 (0%)7/20 (35%)
Most frequent serious events
Most frequent serious events
EventHBeAg Negative ParticipantsHBeAg Positive Participants
chest painCardiac disorders1/40/20
Most frequent other events
Showing 10 of 14
Most frequent other events
EventHBeAg Negative ParticipantsHBeAg Positive Participants
DepressionNervous system disorders2/41/20
Mood disturbanceNervous system disorders1/41/20
TirednessGeneral disorders1/41/20
RashSkin and subcutaneous tissue disorders1/40/20
Non-productive coughRespiratory, thoracic and mediastinal disorders1/40/20
InsomniaPsychiatric disorders1/40/20
Urinary frequencyRenal and urinary disorders1/40/20
Itchy skinSkin and subcutaneous tissue disorders0/41/20
HypothyroidismEndocrine disorders0/41/20
GlaucomaEye disorders0/41/20

Baseline characteristics

Safety analysis population included participants who received at least one dose of study medication and had one subsequent post baseline safety assessment.

Age, Continuous
Age, Continuous(years)HBeAg Negative ParticipantsHBeAg Positive ParticipantsTotal
Mean43.25 ± 5.7531.57 ± 9.4333.52 ± 9.88
Gender
Gender(Participants)HBeAg Negative ParticipantsHBeAg Positive ParticipantsTotal
Female077
Male41317
08

Study locations

6 sites
  • Auckland, New Zealand
  • Hamilton, New Zealand
  • New Plymouth, New Zealand
  • Riccarton, Christchurch, 8011, New Zealand
  • Rotorua, New Zealand
  • Whangarei, New Zealand
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02791269
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jun 6, 2016
Start date
Jan 2006
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Feb 6, 2017
Last update
Feb 6, 2017

Study contacts

Clinical Trials
study chair · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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