Hepatitis B, ChronicPhase 4NCT00927082

A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B

A Phase 4 study testing peginterferon alfa-2a [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 31 sites in 10 countries.

Completed

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

Official record

Search all trials

Trial summary

This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. 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 [Pegasys]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 383 participants
Where: 31 sitesin 10 countries
Study dates: Apr 2009to Nov 2014
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent for Study WV19432
Patients who have completed treatment and follow-up on study WV19432

Who cannot join

As for Study WV19432

Trial locations and contacts

31 sites in 10 countries.

Country

City, postcode or hospital

31 sites in 10 countries

China6 sites

Study site
Beijing, 100050
Study site
Beijing, 100054
Study site
Changsha, 410008
Study site
Guangzhou, 510630
Study site
Shanghai, 200025
Study site
Shanghai, 201508

Other trials in China

Brazil5 sites

Study site
Campinas, São Paulo, 13083-888
Study site
Ribeirão Preto, São Paulo, 14049-900
Study site
Salvador, Estado de Bahia, 40210-341
Study site
Santo André, São Paulo, 09060-650
Study site
São Paulo, São Paulo, 05403-000

Other trials in Brazil

Thailand5 sites

Study site
Bangkok, 10400
Study site
Bangkok, 10700
Study site
Chiang Mai, 50202
Study site
Khon Kaen, 40002
Study site
Songkhla, 90112

Other trials in Thailand

Russia3 sites

Study site
Saint Petersburg, 190103
Study site
Samara, 443100
Study site
Stavropol, 355017

Other trials in Russia

South Korea3 sites

Study site
Seoul, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 138-736

Other trials in South Korea

Taiwan3 sites

Study site
Kaohsiung City, 807
Study site
Taipei, 100
Study site
Taoyuan, 333

Other trials in Taiwan

Hong Kong2 sites

Study site
Hong Kong, 852
Study site
Hong Kong

Other trials in Hong Kong

New Zealand2 sites

Study site
Auckland, 100
Study site
Hamilton

Other trials in New Zealand

Australia1 site

Study site
Fitzroy, Victoria, 3065

Other trials in Australia

Singapore1 site

Study site
Singapore, 169608

Other trials in Singapore

About this study

Official title: A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).

Conditions: Hepatitis B, Chronic
Being tested: peginterferon alfa-2a [Pegasys]
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-2a [Pegasys]Drug
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

Study groups in NCT00927082
Study group	Role	What they receive
PEG-IFN 90mcg 24 Wks	Experimental	Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430. Receives: Drug: peginterferon alfa-2a [Pegasys]
PEG-IFN 180mcg 24 Wks	Experimental	Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430. Receives: Drug: peginterferon alfa-2a [Pegasys]
PEG-IFN 90mcg 48 Wks	Experimental	Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430. Receives: Drug: peginterferon alfa-2a [Pegasys]
PEG-IFN 180mcg 48 Wks	Experimental	Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430. Receives: Drug: peginterferon alfa-2a [Pegasys]

What is being measured

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

Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With HBsAg Loss
HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.
Measured: Annually, for up to 5 years

Secondary outcomes (12)

Percentage of Participants With HBeAg Loss.
HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage 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). Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With Presence of Anti-HBs
The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With Normalised Alanine Transaminase (ALT)
Alanine Transaminase 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 levels increase. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Quantitative HBsAg
Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.
Measured: Annually, for up to 5 years
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.
Measured: Up to 5-year FU period
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).
Measured: Up to 5-year FU period
Number of Participants With Marked Laboratory Abnormalities
Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430
Measured: Up to 5-year FU period

Timeline

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

Apr 2009Nov 2014

First posted24 Jun 2009 (estimated)
Study startApr 2009
Primary completionNov 2014
Study completionNov 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: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00927082
Sponsor's protocol ID: MV22430
Status last verified: Feb 2016
First submitted: 16 Jun 2009
Last updated: 9 Mar 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

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Evaluation of Patients With Liver Disease
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A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Not yet recruitingPhase 1
A Clinical Study of AHB-121 in Healthy Participants and Chronic Hepatitis B (CHB) Participants
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Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
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All Hepatitis B, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).
ClinicalTrials.gov ID: NCT00927082
Acronym / sponsor ID: MV22430
Conditions: Hepatitis B, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 383 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 24 Jun 2009 (estimated)
Results: Posted 9 Mar 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

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
PEG-IFN 90mcg 24 Wks	Experimental	Drug: peginterferon alfa-2a [Pegasys]Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
PEG-IFN 180mcg 24 Wks	Experimental	Drug: peginterferon alfa-2a [Pegasys]Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 90mcg 48 Wks	Experimental	Drug: peginterferon alfa-2a [Pegasys]Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
PEG-IFN 180mcg 48 Wks	Experimental	Drug: peginterferon alfa-2a [Pegasys]Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.

Who may qualify

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

Key inclusion criteria (2 listed)

Informed consent for Study WV19432
Patients who have completed treatment and follow-up on study WV19432

Key exclusion criteria (1 listed)

As for Study WV19432

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-2a [Pegasys]90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)	Drug	PEG-IFN 180mcg 24 Wks, PEG-IFN 180mcg 48 Wks, PEG-IFN 90mcg 24 Wks, PEG-IFN 90mcg 48 Wks

Primary outcome

Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
Time frame: Annually, for up to 5 years
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
Percentage of Participants With HBsAg Loss
Time frame: Annually, for up to 5 years
HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.

12 secondary outcomes

Percentage of Participants With HBeAg Loss.
Time frame: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
Time frame: Annually, for up to 5 years
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
Time frame: Annually, for up to 5 years
Percentage of Participants With Presence of Anti-HBs
Time frame: Annually, for up to 5 years
Percentage of Participants With Normalised Alanine Transaminase (ALT)
Time frame: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
Time frame: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
Time frame: Annually, for up to 5 years
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
Time frame: Annually, for up to 5 years
Quantitative HBsAg
Time frame: Annually, for up to 5 years
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Time frame: Up to 5-year FU period
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Time frame: Up to 5-year FU period
Number of Participants With Marked Laboratory Abnormalities
Time frame: Up to 5-year FU period

Results and safety

Results posted to the registry on 9 Mar 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
PEG-IFN 90mcg 24 Wks	91	79
PEG-IFN 180mcg 24 Wks	87	77
PEG-IFN 90mcg 48 Wks	108	86
PEG-IFN 180mcg 48 Wks	97	78

Primary outcome: Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.

Time frame: Annually, for up to 5 years. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PEG-IFN 90mcg 24 Wks n = 93	PEG-IFN 180mcg 24 Wks n = 89	PEG-IFN 90mcg 48 Wks n = 106	PEG-IFN 180mcg 48 Wks n = 95
End of Treatment (EOT)	9.7 (4.5 to 17.6)	14.6 (8.0 to 23.7)	19.8 (12.7 to 28.7)	31.6 (22.4 to 41.9)
FU Year 1	20.4 (12.8 to 30.1)	31.5 (22.0 to 42.2)	27.4 (19.1 to 36.9)	35.8 (26.2 to 46.3)
FU Year 2	26.9 (18.2 to 37.1)	37.1 (27.1 to 48.0)	30.2 (21.7 to 39.9)	47.4 (37.0 to 57.9)
FU Year 3	38.7 (28.8 to 49.4)	40.4 (30.2 to 51.4)	34.0 (25.0 to 43.8)	52.6 (42.1 to 63.0)
FU Year 4	37.6 (27.8 to 48.3)	44.9 (34.4 to 55.9)	41.5 (32.0 to 51.5)	49.5 (39.1 to 59.9)
FU Year 5	41.9 (31.8 to 52.6)	44.9 (34.4 to 55.9)	40.6 (31.1 to 50.5)	48.4 (38.0 to 58.9)

Population analysed: The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

Primary outcome: Percentage of Participants With HBsAg Loss

Time frame: Annually, for up to 5 years. Number (95% Confidence Interval). Unit: Percentage

Measure	PEG-IFN 90mcg 24 Wks n = 93	PEG-IFN 180mcg 24 Wks n = 89	PEG-IFN 90mcg 48 Wks n = 106	PEG-IFN 180mcg 48 Wks n = 95
EOT	0.0 (0.0 to 3.9)	1.1 (0.0 to 6.1)	1.9 (0.2 to 6.6)	3.2 (0.7 to 9.0)
FU Year 1	1.1 (0.0 to 5.8)	0.0 (0.0 to 4.1)	0.9 (0.0 to 5.1)	1.1 (0.0 to 5.7)
FU Year 2	2.2 (0.3 to 7.6)	0.0 (0.0 to 4.1)	1.9 (0.2 to 6.6)	3.2 (0.7 to 9.0)
FU Year 3	3.2 (0.7 to 9.1)	0.0 (0.0 to 4.1)	1.9 (0.2 to 6.6)	3.2 (0.7 to 9.0)
FU Year 4	3.2 (0.7 to 9.1)	0.0 (0.0 to 4.1)	2.8 (0.6 to 8.0)	2.1 (0.3 to 7.4)
FU Year 5	3.2 (0.7 to 9.1)	0.0 (0.0 to 4.1)	2.8 (0.6 to 8.0)	2.1 (0.3 to 7.4)

Population analysed: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5-year FU period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PEG-IFN 90mcg 24 Wks	5 of 93 (5.4%)	8 of 93 (8.6%)	Not reported
PEG-IFN 180mcg 24 Wks	4 of 89 (4.5%)	8 of 89 (9%)	Not reported
PEG-IFN 90mcg 48 Wks	10 of 106 (9.4%)	8 of 106 (7.5%)	Not reported
PEG-IFN 180mcg 48 Wks	6 of 95 (6.3%)	12 of 95 (12.6%)	Not reported

Limitations and caveats (from the sponsor): Of the responders at FU Year 5, the proportion of patients who were receiving additional anti-HBV treatment after FU Week 24 varied between groups. The frequency of missing values (counted as non-response) was unevenly distributed between groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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 director

Hoffmann-La Roche

31 sites in 10 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 [Pegasys] in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 31 sites in 10 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 2 inclusion and 1 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China, Brazil, Thailand, Russia, South Korea and 5 more countries. 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 9 Mar 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?

Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. (time frame: Annually, for up to 5 years). 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 NCT00927082.

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 9 Mar 2016.