Hepatitis B, ChronicNCT01667432

An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 9 sites in Bulgaria.

Completed

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

Trial summary

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis B, Chronic
What is being tested?: Peginterferon alfa-2a
Type of treatment: Injection or infusion
How many people: 141 participants
Where: 9 sitesBulgaria
Study dates: 8 Jul 2011to 12 Aug 2014
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with chronic hepatitis B on treatment with PEGASYS.

Who may be able to join

Adult patients ≥ 18 years of age.
Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but ≤ 10 x ULN according to local label.

Who cannot join

Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
Concomitant treatment with telbivudine.
Pregnant or lactating women.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Bulgaria9 sites

Mhat - Pleven; Clinic of Gastroenterology
Pleven, 5800
Umhat St. Georgi; Clinical of Gastroenterology
Plovdiv, 4002
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, 1407
UMHAT Alexandrovska EAD; Gastroenterology
Sofia, 1431
Mhat Queenjoanna; Clinic of Gastroenterology
Sofia, 1527
Military Medical Academy; Gastroenterology
Sofia, 1606
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, 1612
Mhat St. Zagora; Clinical of Gastroenterology
Stara Zagora, 6000
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, 9010

Other trials in Bulgaria

About this study

Official title: A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)

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-2aBiological
Also called PEGASYS®, RO0258310
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.

Study groups in NCT01667432
Study group	Role	What they receive
Peginterferon alfa-2a		Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. Receives: Biological: Peginterferon alfa-2a

What is being measured

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

Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).
Measured: At the end of the study (Week 36)
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
Measured: approximately 3 years
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
Measured: approximately 3 years

Secondary outcomes (6)

Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.
Measured: At the end of treatment (Week 24)
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
Measured: approximately 3 years
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Measured: approximately 3 years
Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Measured: approximately 3 years
Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
Measured: approximately 3 years
Safety: Incidence of Adverse Events
Measured: approximately 3 years

Timeline

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

8 Jul 201112 Aug 2014

First posted17 Aug 2012 (estimated)
Study start8 Jul 2011
Primary completion12 Aug 2014
Study completion12 Aug 2014

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01667432
Sponsor's protocol ID: ML25626
Status last verified: Mar 2017
First submitted: 15 Aug 2012
Last updated: 10 Apr 2017
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 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)
ClinicalTrials.gov ID: NCT01667432
Acronym / sponsor ID: ML25626
Conditions: Hepatitis B, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 141 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 8 Jul 2011 (actual)
Primary completion: 12 Aug 2014 (actual)
Study completion: 12 Aug 2014 (actual)
First posted: 17 Aug 2012 (estimated)
Results: Posted 7 Dec 2015

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Peginterferon alfa-2a	–	Biological: Peginterferon alfa-2aParticipants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic hepatitis B on treatment with PEGASYS.

Key inclusion criteria (3 listed)

Adult patients ≥ 18 years of age.
Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but ≤ 10 x ULN according to local label.

Key exclusion criteria (4 listed)

Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
Concomitant treatment with telbivudine.
Pregnant or lactating women.

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®, RO0258310Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.	Biological	Peginterferon alfa-2a

Primary outcome

Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
Time frame: At the end of the study (Week 36)
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
Time frame: approximately 3 years
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
Time frame: approximately 3 years

6 secondary outcomes

Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
Time frame: At the end of treatment (Week 24)
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
Time frame: approximately 3 years
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time frame: approximately 3 years
Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
Time frame: approximately 3 years
Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
Time frame: approximately 3 years
Safety: Incidence of Adverse Events
Time frame: approximately 3 years

Results and safety

Results posted to the registry on 7 Dec 2015, 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	141	84

Primary outcome: Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study

Time frame: At the end of the study (Week 36). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Peginterferon Alfa-2a n = 139
Value	38.8 (30.70 to 47.48)

Population analysed: Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.

Primary outcome: Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml

Time frame: approximately 3 years

The sponsor has not posted figures for this outcome.

Primary outcome: In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive

Time frame: approximately 3 years

The sponsor has not posted figures for this outcome.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peginterferon Alfa-2a	1 of 139 (0.7%)	78 of 139 (56.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B, Chronic, run by Hoffmann-La Roche at 9 sites in Bulgaria.

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 3 inclusion and 4 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 10 Apr 2017. 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 Bulgaria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2015). 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?

Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study (time frame: At the end of the study (Week 36)). The study lists 3 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 NCT01667432.

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 10 Apr 2017.