Trial record 16 of 1890 for:    "Hepatitis, Chronic"

PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients (PAS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01373684
Recruitment Status : Recruiting
First Posted : June 15, 2011
Last Update Posted : December 21, 2017
Hoffmann-La Roche
Information provided by (Responsible Party):
Foundation for Liver Research

Brief Summary:
This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Peginterferon alfa-2a Drug: Nucleos(t)ide analogue Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of HBsAg Decline Using an add-on Treatment of Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogous (PAS)
Study Start Date : March 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Peginterferon alfa-2a add on
All patients are all currently being treated with long-term NA treatment. PEG-IFN will be given in a dose of 180 μg per week s.c. for a total duration of 48 weeks starting at week 0.
Drug: Peginterferon alfa-2a
180 μg per week s.c. for a total duration of 48 weeks.
Other Name: Pegasys

Active Comparator: Nucleoside analogue
All patients are all currently being treated with long-term Nucleos(t)ide analogue treatment and will continue using this medication during the duration of the study.
Drug: Nucleos(t)ide analogue
All patients are all currently being treated with long-term NA treatment and will continue using these during the study. Dosage depends on which Nucleos(t)ide analogue they are using.
Other Names:
  • Entecavir (Baraclude)
  • Tenofovir (Viread)
  • Adefovir (Hepsera)

Primary Outcome Measures :
  1. HBsAg decline [ Time Frame: week 48 ]
    HBsAg decline > 1 log from baseline at week 48

Secondary Outcome Measures :
  1. HBsAg decline [ Time Frame: week 24 and 72 ]
    HBsAg decline > 1 log at weeks 24 and 72

  2. HBsAg decline [ Time Frame: week 24 and 48 ]
    HBsAg decline > 0.5 log at weeks 24 and 48

  3. HBsAg loss [ Time Frame: week 48 and 72 ]
    HBsAg loss at weeks 48 and 72

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic hepatitis B (HBsAg positive > 6 months)
  • HBeAg negative within six months prior to initiation of peginterferon alfa-2a
  • HBV DNA < 200 IU/ml during nucleos(t)ide analogue (except Telbivudine) treatment within one month prior to initiation of peginterferon alfa-2a
  • Compensated liver disease
  • Age > 18 years
  • Written informed consent

Exclusion Criteria:

  • Treatment with any investigational drug within 30 days of entry to this protocol
  • Current treatment with Telbivudine
  • Severe hepatitis activity as documented by ALT>10 x ULN
  • History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy)
  • Pre-existent neutropenia (neutrophils <1,500/mm3) or thrombocytopenia (platelets < 90,000/mm3)
  • Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV)
  • Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
  • Alpha fetoprotein > 50 ng/ml
  • Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met)
  • Immune suppressive treatment within the previous 6 months
  • Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
  • Pregnancy, breast-feeding
  • Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
  • Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
  • Substance abuse, such as alcohol (>80 g/day), I.V. drugs and inhaled drugs in the past 2 years.
  • Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study

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 identifier (NCT number): NCT01373684

Contact: H.L.A. Janssen, MD PhD +14166035800 ext 2776
Contact: K.S. Liem, MD

Western Hospital Recruiting
Toronto, Canada
Erasmus Medical Center Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015 CE
Contact: M.J.H. van Campenhout, MD    +31107034513   
Principal Investigator: H.L.A. Janssen, MD PhD         
Sub-Investigator: M.J.H. van Campenhout, MD         
Sub-Investigator: K.S. Liem, MD         
Medisch Centrum Alkmaar Recruiting
Alkmaar, Netherlands
Onze Lieve Vrouwen Gasthuis Recruiting
Amsterdam, Netherlands
VU university medical center Recruiting
Amsterdam, Netherlands
Rijnstate Hospital Recruiting
Arnhem, Netherlands
Reinier de Graaf Gasthuis Recruiting
Delft, Netherlands
MC Haaglanden Recruiting
Den Haag, Netherlands
Catharina ziekenhuis Recruiting
Eindhoven, Netherlands
Spaarne Gasthuis Recruiting
Haarlem, Netherlands
Atrium Medical Center Recruiting
Heerlen, Netherlands
LUMC Recruiting
Leiden, Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
Hoffmann-La Roche
Principal Investigator: H.L.A. Janssen, MD PhD Erasmus Medical Center

Responsible Party: Foundation for Liver Research Identifier: NCT01373684     History of Changes
Other Study ID Numbers: HBV11-01
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Keywords provided by Foundation for Liver Research:
Chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis A
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
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs