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

December 29, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
      • Napoli, Campania, Italy, 80131
        • Nuovo Policlinico; Dipartimento di Malattie Infettive
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Bologna, Emilia-Romagna, Italy, 40138
        • UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Medica
    • Lazio
      • Roma, Lazio, Italy, 00133
      • Roma, Lazio, Italy, 00161
      • Roma, Lazio, Italy, 00161
        • Policlinico Umberto I Di Roma
    • Liguria
      • Genova, Liguria, Italy, 16132
      • Genova, Liguria, Italy, 16132
        • D.I,M.I.; Cattedra Di Gastroenterologia
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
      • Milano, Lombardia, Italy, 20122
    • Piemonte
      • Torino, Piemonte, Italy, 10126
      • Torino, Piemonte, Italy, 10126
        • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Gastroenterologia
    • Puglia
      • Foggia, Puglia, Italy, 71100
      • Foggia, Puglia, Italy, 71100
        • A.O. Universitaria Ospedali Riuniti Di Foggia; Malattie Infettive
    • Sardegna
      • Cagliari, Sardegna, Italy, 09042
      • Cagliari, Sardegna, Italy, 09042
        • Uni Di Cagliari; Dept. Di Scienze Mediche
      • Cagliari, Sardegna, Italy, 09042
        • A.O. Universitaria Policlinico Monserrato Di Cagliari; Gastroenterologia
    • Sicilia
      • Messina, Sicilia, Italy, 98124
      • Messina, Sicilia, Italy, 98124
        • Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica
      • Palermo, Sicilia, Italy, 90127
      • Palermo, Sicilia, Italy, 90127
        • Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia
    • Toscana
      • Pisa, Toscana, Italy, 56124
      • Pisa, Toscana, Italy, 56124
        • Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
    • Veneto
      • Padova, Veneto, Italy, 35128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pegylated Interferon (Peginterferon) Alfa-2a
Participants 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.
Drug: Pegylated Interferon (Peginterferon) Alfa-2a
Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.
Other Names:
  • Pegasys
Drug: Nucleos(t)ide Analogues (NA)
Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to Week 48
Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)
Time Frame: Baseline and 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.
Baseline and Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96
Time Frame: Baseline, Week 24, 72 and 96
Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.
Baseline, Week 24, 72 and 96
Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48
Time Frame: Baseline, Week 48
Baseline, Week 48
Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96
Time Frame: Week 12 up to Week 96
HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.
Week 12 up to Week 96
Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes
Time Frame: Baseline and Week 48
Baseline and Week 48
Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels
Time Frame: Baseline and Week 48
Baseline and Week 48
Safety: Percentage of Participants With Adverse Events (AE)
Time Frame: Baseline up to Week 48
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.
Baseline up to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 20, 2017

Last Update Submitted That Met QC Criteria

December 29, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28262
  • 2012-000080-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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