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AzTrials

Hepatitis B, ChronicPhase 2NCT01706575

A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

A Phase 2 study testing Pegylated Interferon (Peginterferon) Alfa-2a and Nucleos(t)ide Analogues (NA) in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 27 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

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Pegylated Interferon (Peginterferon) Alfa-2a and Nucleos(t)ide Analogues (NA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
27 sitesItaly
Study dates
Jan 2013to Nov 2014
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants, 18 - 65 years of age
  • Chronic hepatitis B
  • Negative for HBeAg
  • On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months
  • HBsAg >100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys
  • Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from Week -12 to start of the Add-on phase)
  • Negative pregnancy test for women of childbearing potential
  • Women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the Add-on phase

Who cannot join

  • Coinfection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), Human Immunodeficiency virus (HIV)
  • Evidence of decompensated liver disease (Child-Pugh >/=6)
  • History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
  • Known hypersensitivity to peginterferon alfa-2a
  • Pregnant of breastfeeding women
  • Evidence of alcohol and/or drug abuse
Show all 15Show fewer
  • History of severe psychiatric disease, especially depression
  • History of immunologically mediated disease
  • History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • History or evidence of severe pulmonary disease associated with functional limitations
  • History of severe cardiac disease
  • History of severe seizure disorder or current anticonvulsant use
  • Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry
  • History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment </= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study
  • History or other evidence of severe retinopathy

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Italy27 sites

  • UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

    Bologna, Emilia-Romagna, 40138

  • Study site

    Bologna, Emilia-Romagna, 40138

  • A.O. Universitaria Policlinico Monserrato Di Cagliari; Gastroenterologia

    Cagliari, Sardinia, 09042

  • Uni Di Cagliari; Dept. Di Scienze Mediche

    Cagliari, Sardinia, 09042

  • Study site

    Cagliari, Sardinia, 09042

  • A.O. Universitaria Ospedali Riuniti Di Foggia; Malattie Infettive

    Foggia, Apulia, 71100

  • Study site

    Foggia, Apulia, 71100

  • D.I,M.I.; Cattedra Di Gastroenterologia

    Genoa, Liguria, 16132

  • Study site

    Genoa, Liguria, 16132

  • Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica

    Messina, Sicily, 98124

  • Study site

    Messina, Sicily, 98124

  • Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20122

  • Nuovo Policlinico; Dipartimento di Malattie Infettive

    Naples, Campania, 80131

  • Study site

    Naples, Campania, 80131

  • Study site

    Padova, Veneto, 35128

  • Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia

    Palermo, Sicily, 90127

  • Study site

    Palermo, Sicily, 90127

  • Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

    Pisa, Tuscany, 56124

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Rome, Lazio, 00133

  • Policlinico Umberto I Di Roma

    Rome, Lazio, 00161

  • Study site

    Rome, Lazio, 00161

  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Gastroenterologia

    Turin, Piedmont, 10126

  • Study site

    Turin, Piedmont, 10126

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Medica

    Udine, Friuli Venezia Giulia, 33100

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

About this study

Official title: A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks PEG-Interferon Alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genotype D Patients on Treatment With Nucleos(t)Ide Analogues (NAs), Showing Stable HBV DNA Suppression

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.

Being tested
Pegylated Interferon (Peginterferon) Alfa-2a, Nucleos(t)ide Analogues (NA)
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.

  • Pegylated Interferon (Peginterferon) Alfa-2aDrug

    Also called Pegasys

    Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.

  • Nucleos(t)ide Analogues (NA)Drug

    Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

Study groups in NCT01706575
Study groupRoleWhat they receive
Pegylated Interferon (Peginterferon) Alfa-2aExperimentalParticipants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
Receives: Drug: Pegylated Interferon (Peginterferon) Alfa-2a; Drug: Nucleos(t)ide Analogues (NA)

What is being measured

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

  1. Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)

    Measured: Baseline up to Week 48

  2. Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)

    Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.

    Measured: Baseline and Week 48

Secondary outcomes (6)

  1. Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96

    Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.

    Measured: Baseline, Week 24, 72 and 96

  2. Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48

    Measured: Baseline, Week 48

  3. Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96

    HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.

    Measured: Week 12 up to Week 96

  4. Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes

    Measured: Baseline and Week 48

  5. Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels

    Measured: Baseline and Week 48

  6. Safety: Percentage of Participants With Adverse Events (AE)

    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: Baseline up to Week 48

Timeline

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

  1. First posted15 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionSep 2013
  4. Study completionNov 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706575
Sponsor's protocol ID
ML28262
Other IDs
2012-000080-25
Status last verified
Dec 2016
First submitted
10 Oct 2012
Last updated
20 Feb 2017

Publications

  • Lampertico P, Brunetto MR, Craxi A, Gaeta GB, Rizzetto M, Rozzi A, Colombo M; HERMES Study Group. Add-on peginterferon alfa-2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B 'e' antigen-negative chronic hepatitis B genotype D. J Viral Hepat. 2019 Jan;26(1):118-125. doi: 10.1111/jvh.12999. Epub 2018 Dec 11.

    PubMed 30187599

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated Interferon (Peginterferon) Alfa-2a and Nucleos(t)ide Analogues (NA) in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 27 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 8 inclusion and 15 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 20 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 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 5 Aug 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?

Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) (time frame: Baseline up to Week 48). 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 NCT01706575, which also lists 1 linked publication.

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 20 Feb 2017.

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