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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

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ClinicalTrials.gov Identifier: NCT01706575
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : August 5, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief 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. 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 or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Pegylated Interferon (Peginterferon) Alfa-2a Drug: Nucleos(t)ide Analogues (NA) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2014

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U.S. FDA Resources

Arms and Interventions
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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 Name: Pegasys
Drug: Nucleos(t)ide Analogues (NA)
Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. 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.

  2. Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48 [ Time Frame: Baseline, Week 48 ]
  3. 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.

  4. Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes [ Time Frame: Baseline and Week 48 ]
  5. Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels [ Time Frame: Baseline and Week 48 ]
  6. 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.


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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706575


Locations
Italy
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01706575     History of Changes
Other Study ID Numbers: ML28262
2012-000080-25 ( EudraCT Number )
First Posted: October 15, 2012    Key Record Dates
Results First Posted: August 5, 2016
Last Update Posted: February 20, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Hepatitis
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
Interferons
Peginterferon alfa-2a
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs