Hepatitis B, ChronicPhase 3NCT01697501

A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253

A Phase 3 study testing Interleukin 28B testing in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 12 sites in Italy.

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 years and older
Conditions the study is for: Hepatitis B, Chronic
What is being tested?: Interleukin 28B testing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 12 sitesItaly
Study dates: 8 Nov 2012to 21 Jun 2013
Phase: Phase 3
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

Adult patients, >/= 18 years of age
Chronic hepatitis B
Previous participation in study ML18253
Administration of at least one dose of the study drug during ML18253 study

Who cannot join

Patients not satisfying the above inclusion criteria will not be enrolled in the study

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Italy12 sites

Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive
Bari, Apulia, 70124
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Bologna, Emilia-Romagna, 40138
Uni Di Cagliari; Dept. Di Scienze Mediche
Cagliari, Sardinia, 09042
Az. Osp. S. Sebastiano; Divisione Malattie Infettive
Caserta, Campania, 81100
Ospedale de Bellis; Reparto Medicina Generale
Castellana Grotte, Apulia, 70013
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
Milan, Lombardy, 20122
Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale
Milan, Lombardy, 20122
Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia
Naples, Campania, 80131
Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.
Padova, Veneto, 35128
Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
Palermo, Sicily, 90127
Az. Osp. Uni Ria Di Parma; Gastro-Enterology
Parma, Emilia-Romagna, 43100
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
Pisa, Tuscany, 56124

Other trials in Italy

About this study

Official title: Cross-sectional Multicenter Study Evaluating the IL28B Polymorphism in Patients With HBeAg-negative Chronic Hepatitis B Treated With Pegylated Interferon Alfa-2a in the Course of Peg.Be.Liver Study

This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the predecessor ML18253 study. The study consists of a single visit where eligible patients will undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.

Conditions: Hepatitis B, Chronic
Being tested: Interleukin 28B testing
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.

Interleukin 28B testingOther
Blood sampling for IL28B genotyping

Study groups in NCT01697501
Study group	Role	What they receive
Chronic hepatitis B patients	Experimental	Not described Receives: Other: Interleukin 28B testing

What is being measured

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

Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)
Measured: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
Measured: EoF

Secondary outcomes (6)

Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
Measured: EoT, as defined in the predecessor study, was at Week 48 or Week 96
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
Measured: EoT
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Measured: EoT and EoF
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Measured: EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Measured: EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Measured: EoT and EoF

Timeline

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

8 Nov 201221 Jun 2013

First posted2 Oct 2012 (estimated)
Study start8 Nov 2012
Primary completion21 Jun 2013
Study completion21 Jun 2013

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 3
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01697501
Sponsor's protocol ID: ML28470
Other IDs: 2012-002777-56
Status last verified: Mar 2017
First submitted: 28 Sep 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

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)
Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingPhase 2
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
Chronic Hepatitis B Virus

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: Cross-sectional Multicenter Study Evaluating the IL28B Polymorphism in Patients With HBeAg-negative Chronic Hepatitis B Treated With Pegylated Interferon Alfa-2a in the Course of Peg.Be.Liver Study
ClinicalTrials.gov ID: NCT01697501
Acronym / sponsor ID: ML28470
Conditions: Hepatitis B, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 8 Nov 2012 (actual)
Primary completion: 21 Jun 2013 (actual)
Study completion: 21 Jun 2013 (actual)
First posted: 2 Oct 2012 (estimated)
Results: Posted 10 Jul 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

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

Arm	Type	Receives
Chronic hepatitis B patients	Experimental	Other: Interleukin 28B testing

Who may qualify

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

Key inclusion criteria (4 listed)

Adult patients, >/= 18 years of age
Chronic hepatitis B
Previous participation in study ML18253
Administration of at least one dose of the study drug during ML18253 study

Key exclusion criteria (1 listed)

Patients not satisfying the above inclusion criteria will not be enrolled in the study

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
Interleukin 28B testingBlood sampling for IL28B genotyping	Other	Chronic hepatitis B patients

Primary outcome

Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)
Time frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
Time frame: EoF

6 secondary outcomes

Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
Time frame: EoT, as defined in the predecessor study, was at Week 48 or Week 96
Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
Time frame: EoT
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time frame: EoT and EoF
Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time frame: EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
Time frame: EoT and EoF
Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
Time frame: EoT and EoF

Results and safety

Results posted to the registry on 10 Jul 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
Chronic Hepatitis B Patients	88	86

Primary outcome: Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)

Time frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.. Number. Unit: percentage of participants

Measure	"CC" n = 35	"TC" n = 41	"TT" n = 10	"TC+TT" n = 51	"Overall" n = 86
Value	20.0	17.1	20.0	17.6	18.6

"CC" vs "TC+TT": Odds Ratio (OR): 0.86 (95% CI 0.29 to 2.57), p = 0.7831, univariate logistic analysis

Population analysed: Full analysis set (FAS), defined as all subjects who completed

Primary outcome: Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF

Time frame: EoF. Number. Unit: percentage of participants

Measure	"TT" n = 52	"GT" n = 31	"GG" n = 3	"GT+GG" n = 34	"Overall" n = 86
Value	23.1	12.9	0.0	11.8	18.6

"TT" vs "GT+GG": Odds Ratio (OR): 2.25 (95% CI 0.66 to 7.67), p = 0.1951, univariate logistic analysis

Population analysed: FAS

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study consisted of a single visit where eligible patients undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit. All subjects enrolled are included in the safety analysis set.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Hepatitis B Patients	0 of 88 (0%)	0 of 88 (0%)	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

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)
Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingPhase 2
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
Chronic Hepatitis B Virus

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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interleukin 28B testing in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 12 sites in Italy.

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 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 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 12 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Jul 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 Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF) (time frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.). 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 NCT01697501.

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.