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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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 10, 2012
Last updated: December 29, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: Pegylated Interferon (Peginterferon) Alfa-2a
Drug: Nucleos(t)ide Analogues (NA)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]
  • 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.

Secondary Outcome Measures:
  • 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.

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

  • Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes [ Time Frame: Baseline and Week 48 ]
  • Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels [ Time Frame: 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.

Enrollment: 76
Study Start Date: January 2013
Study Completion Date: November 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pegasys
Drug: Nucleos(t)ide Analogues (NA)
Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01706575

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01706575     History of Changes
Other Study ID Numbers: ML28262
2012-000080-25 ( EudraCT Number )
Study First Received: October 10, 2012
Results First Received: June 24, 2016
Last Updated: December 29, 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017