Hepatitis B, ChronicPhase 4NCT00436163

A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B

A Phase 4 study testing Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 39 participants
Where: 9 sitesin 3 countries
Study dates: Mar 2007to May 2010
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

Adult participants, 18-70 years of age;
HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
anti-HBs negative;
Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.

Who cannot join

Previous antiviral or interferon-based therapy for chronic hepatitis B;
Evidence of decompensated liver disease;
Chronic liver disease other than viral hepatitis;
Co-infection with active hepatitis A, C or D virus;
Co-infection with human immunodeficiency virus.

Trial locations and contacts

9 sites in 3 countries.

Country

City, postcode or hospital

9 sites in 3 countries

Lithuania5 sites

Study site
Kaunas, 47144
Study site
Kaunas, 50009
Study site
Klaipėda, 92288
Study site
Vilnius, 08117
Study site
Vilnius, 08661

Other trials in Lithuania

Estonia3 sites

Study site
Tallinn, 10138
Study site
Tallinn, 10617
Study site
Tartu, 51014

Other trials in Estonia

Latvia1 site

Study site
Riga, 1006

Other trials in Latvia

About this study

Official title: Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B

This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.

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 subcutaneously once per week for 48 weeks.

Study groups in NCT00436163
Study group	Role	What they receive
Peginterferon Alfa-2a	Experimental	Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks. Receives: Drug: Peginterferon alfa-2a

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Measured: Week 72
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
Measured: Week 72

Secondary outcomes (6)

Number of Participants With HBV-DNA < 400 Copies/mL
Measured: Week 72
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants. Percentage of HBsAg negative participants were reported.
Measured: Week 48 and Week 72
Percentage of Anti-HBs Positive Participants
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants. Percentage of Anti-HBs positive participants were reported.
Measured: Week 48 and Week 72
Mean Alanine Aminotransferase (ALT) Concentrations
Measured: Week 48 and Week 72
Percentage of HBeAg Negative Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants. Percentage of HBeAg negative participants were reported.
Measured: Week 48 and Week 72
Percentage of Anti-HBe Positive Participants
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants. Percentage of Anti-HBe positive participants were reported.
Measured: Week 48 and Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007May 2010

First posted16 Feb 2007 (estimated)
Study startMar 2007
Primary completionMay 2010
Study completionMay 2010

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00436163
Sponsor's protocol ID: ML20601
Status last verified: Aug 2016
First submitted: 15 Feb 2007
Last updated: 24 Oct 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
ClinicalTrials.gov ID: NCT00436163
Acronym / sponsor ID: ML20601
Conditions: Hepatitis B, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 16 Feb 2007 (estimated)
Results: Posted 24 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Peginterferon Alfa-2a	Experimental	Drug: Peginterferon alfa-2aParticipants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult participants, 18-70 years of age;
HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
anti-HBs negative;
Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.

Key exclusion criteria (5 listed)

Previous antiviral or interferon-based therapy for chronic hepatitis B;
Evidence of decompensated liver disease;
Chronic liver disease other than viral hepatitis;
Co-infection with active hepatitis A, C or D virus;
Co-infection with human immunodeficiency virus.

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: Pegasys®180 mcg subcutaneously once per week for 48 weeks.	Drug	Peginterferon Alfa-2a

Primary outcome

Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
Time frame: Week 72
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
Time frame: Week 72
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.

6 secondary outcomes

Number of Participants With HBV-DNA < 400 Copies/mL
Time frame: Week 72
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
Time frame: Week 48 and Week 72
Percentage of Anti-HBs Positive Participants
Time frame: Week 48 and Week 72
Mean Alanine Aminotransferase (ALT) Concentrations
Time frame: Week 48 and Week 72
Percentage of HBeAg Negative Participants
Time frame: Week 48 and Week 72
Percentage of Anti-HBe Positive Participants
Time frame: Week 48 and Week 72

Results and safety

Results posted to the registry on 24 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Peginterferon Alfa-2a	39	36

Primary outcome: Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)

Time frame: Week 72. Number. Unit: participants

Measure	Peginterferon Alfa-2a n = 22
Value	6

Population analysed: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg positive at baseline.

Primary outcome: Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL

Time frame: Week 72. Number. Unit: participants

Measure	Peginterferon Alfa-2a n = 17
Value	6

Population analysed: All enrolled participants who received at least 1 dose of peginterferon alfa-2a. Here, Number of participants analyzed = participants who were HBeAg negative at baseline.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were recorded from Screening till Week 72.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginterferon Alfa-2a	0 of 39 (0%)	15 of 39 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis B, Chronic

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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 director

Hoffmann-La Roche

9 sites in 3 countries: 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 9 sites in 3 countries.

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 4 inclusion and 5 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Lithuania, Estonia, Latvia. 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 24 Oct 2016). 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 Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL) (time frame: 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?

On the ClinicalTrials.gov record for NCT00436163.

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 24 Oct 2016.