PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients (PADD)
This study is currently recruiting participants.
Verified January 2013 by Foundation for Liver Research
Sponsor:
Foundation for Liver Research
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01373684
First received: June 14, 2011
Last updated: January 8, 2013
Last verified: January 2013
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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 (PADD Negative) |
Resource links provided by NLM:
Drug Information available for:
Interferon
Interferon Alfa-2a
Entecavir
Adefovir dipivoxil
Tenofovir
Peginterferon Alfa-2a
Tenofovir Disoproxil Fumarate
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373684
Contacts
| Contact: H.L.A. Janssen, MD PhD | +31107035942 | h.janssen@erasmusmc.nl |
| Contact: P. Arends, MD | +31107031618 | p.arends@erasmusmc.nl |
Locations
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Zuid Holland, Netherlands, 3015 CE | |
| Contact: P. Arends, MD +31107031618 p.arends@erasmusmc.nl | |
| Principal Investigator: H.L.A. Janssen, MD PhD | |
| Sub-Investigator: P. Arends, MD | |
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: | January 8, 2013 |
| 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, 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 Interferon-alpha Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013