Hepatitis B, ChronicPhase 4NCT02791269
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
A Phase 4 study testing Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 6 sites in New Zealand.
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 infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Peginterferon alfa-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesNew Zealand
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
New Zealand6 sites
Study site
Auckland
Study site
Hamilton
Study site
New Plymouth
Study site
Riccarton, Christchurch, 8011
Study site
Rotorua
Study site
Whangarei
About this study
Official title: Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) in Patients With HBeAg-Positive And HBeAg-Negative Chronic Hepatitis B
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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Peginterferon alfa-2a
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
Also called Pegasys
180 mcg SC injection QW for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HBeAg Negative Participants | Experimental | 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. Receives: Drug: Peginterferon alfa-2a |
| HBeAg Positive Participants | Experimental | 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. Receives: Drug: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of 24-weeks follow-up (Week 72)
Number of Participants With HBV-DNA <20,000 Copies/mL
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Measured: End of 24-weeks follow-up (Week 72)
Secondary outcomes (4)
Number of Participants With HBV-DNA <400 Copies/mL
HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Measured: Week 48 (end of treatment) and Week 72 (end of follow-up)
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.
Measured: Week 48 (end of treatment) and Week 72 (end of follow-up)
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).
Measured: Week 48 (end of treatment) and Week 72 (end of follow-up)
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).
Measured: Week 48 (end of treatment) and Week 72 (end of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791269
- Sponsor's protocol ID
- ML19295
- Status last verified
- Dec 2016
- First submitted
- 31 May 2016
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) in Patients With HBeAg-Positive And HBeAg-Negative Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02791269
- Acronym / sponsor ID
- ML19295
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBeAg Negative Participants | Experimental | Drug: Peginterferon alfa-2aHBeAg 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 | Experimental | Drug: Peginterferon alfa-2aHBeAg 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon alfa-2aAlso: Pegasys180 mcg SC injection QW for 48 weeks. | Drug | HBeAg Negative Participants, HBeAg Positive Participants |
Primary outcome
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.
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.
4 secondary outcomes
Number of Participants With HBV-DNA <400 Copies/mL
Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion
Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level
Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
Number of Participants With HBeAg Seroconversion
Time frame: Week 48 (end of treatment) and Week 72 (end of follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 6 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.