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

This study is not yet open for participant recruitment.
Verified March 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01706575
First received: October 10, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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 patients with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, patients 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 patients will continue their NA treatment.


Condition Intervention Phase
Hepatitis B, Chronic
 Drug: peginterferon alfa-2a [Pegasys]
Drug: nucleos(t)ide analogues
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with serum HBsAg decrease >/= 50% from baseline to the end of the combination treatment Pegasys plus NA (Study Week 48) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with HBsAg decrease >/=1 log10 IU/ml from baseline to Week 48 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Change in HBsAg levels [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Proportion of patients with HBsAg </= 0.05 UI/ml at Week 48 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with HBsAg </= 0.05 UI/ml at Week 72 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Proportion of patients with HBsAg </= 0.05 UI/ml at Week 96 [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • HBsAg levels according to IL28B genotypes [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • HBsAg levels according to IP-10 serum levels [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 81
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegasys Drug: peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly, 48 weeks
Drug: nucleos(t)ide analogues
Adenovir, entecavir, lamivudine or tenofovir

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 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 HAV, HCV, HDV, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706575

Contacts
Contact: Please reference Study ID Number: ML28262 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Italy
Recruiting
Bologna, Italy, 40138
Not yet recruiting
Cagliari, Italy, 09042
Recruiting
Foggia, Italy, 71100
Recruiting
Genova, Italy, 10100
Recruiting
Messina, Italy, 98124
Recruiting
Milano, Italy, 20122
Not yet recruiting
Monserrato, Italy, 09042
Recruiting
Napoli, Italy, 80131
Recruiting
Padova, Italy, 35128
Recruiting
Palermo, Italy, 90127
Recruiting
Pisa, Italy, 56124
Recruiting
Roma, Italy, 00161
Not yet recruiting
Roma, Italy, 00133
Not yet recruiting
Torino, Italy, 10126
Recruiting
Udine, Italy, 33100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01706575     History of Changes
Other Study ID Numbers: ML28262, 2012-000080-25
Study First Received: October 10, 2012
Last Updated: March 18, 2013
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013