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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Foundation for Liver Research
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01373684
First received: June 14, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Drug: Peginterferon alfa-2a
Drug: Nucleos(t)ide analogue
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • HBsAg decline [ Time Frame: week 48 ] [ Designated as safety issue: No ]
    HBsAg decline > 1 log from baseline at week 48


Secondary Outcome Measures:
  • HBsAg decline [ Time Frame: week 24 and 72 ] [ Designated as safety issue: No ]
    HBsAg decline > 1 log at weeks 24 and 72

  • HBsAg decline [ Time Frame: week 24 and 48 ] [ Designated as safety issue: No ]
    HBsAg decline > 0.5 log at weeks 24 and 48

  • HBsAg loss [ Time Frame: week 48 and 72 ] [ Designated as safety issue: No ]
    HBsAg loss at weeks 48 and 72


Estimated Enrollment: 90
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis B (HBsAg positive > 6 months)
  • HBeAg negative and anti-HBe positive 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373684

Contacts
Contact: H.L.A. Janssen, MD PhD +14166035800 ext 2776 harry.janssen@uhn.ca
Contact: M.J.H. van Campenhout, MD +31107034513 m.vancampenhout@erasmusmc.nl

Locations
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015 CE
Contact: M.J.H. van Campenhout, MD    +31107034513    m.vancampenhout@erasmusmc.nl   
Principal Investigator: H.L.A. Janssen, MD PhD         
Sub-Investigator: M.J.H. van Campenhout, MD         
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
Atrium Medical Center Recruiting
Heerlen, 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
Investigators
Principal Investigator: H.L.A. Janssen, MD PhD Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT01373684     History of Changes
Other Study ID Numbers: HBV11-01
Study First Received: June 14, 2011
Last Updated: April 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Foundation for Liver Research:
Chronic hepatitis B
HBeAg-negative

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

ClinicalTrials.gov processed this record on October 21, 2014