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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706575
First Posted: October 15, 2012
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
October 10, 2012
October 15, 2012
June 24, 2016
August 5, 2016
February 20, 2017
January 2013
September 2013   (Final data collection date for 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 ]
  • 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.
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 ]
Complete list of historical versions of study NCT01706575 on ClinicalTrials.gov Archive Site
  • 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.
  • Proportion of patients with HBsAg decrease >/=1 log10 IU/ml from baseline to Week 48 [ Time Frame: approximately 2.5 years ]
  • Change in HBsAg levels [ Time Frame: from baseline to Week 96 ]
  • Proportion of patients with HBsAg </= 0.05 UI/ml at Week 48 [ Time Frame: approximately 2.5 years ]
  • Proportion of patients with HBsAg </= 0.05 UI/ml at Week 72 [ Time Frame: approximately 2.5 years ]
  • Proportion of patients with HBsAg </= 0.05 UI/ml at Week 96 [ Time Frame: approximately 2.5 years ]
  • HBsAg levels according to IL28B genotypes [ Time Frame: approximately 2.5 years ]
  • HBsAg levels according to IP-10 serum levels [ Time Frame: approximately 2.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ]
Not Provided
Not Provided
 
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 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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis B, Chronic
  • 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.
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.
Interventions:
  • Drug: Pegylated Interferon (Peginterferon) Alfa-2a
  • Drug: Nucleos(t)ide Analogues (NA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
November 2014
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01706575
ML28262
2012-000080-25 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP