A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (PEGAN)
This study is ongoing, but not recruiting participants.
Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01172392
First received: July 28, 2010
Last updated: March 28, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B AgHbs Negativation |
Drug: Pegylated interferon-alpha-2a Drug: Nucleotidic or Nucleosidic Treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Unblinded, Phase III Study Assessing the Loss of HbsAg at W96 After a 48-week Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (HbeAg Negative) Under Treatment and Responders (Undetectable Viral Load) to a Nucleoside(s) or Nucleotide(s) Analog(s) Treatment for at Least 12 Months. ANRS HB 06 Pegan |
Resource links provided by NLM:
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- HbsAg negativation at week 96 [ Time Frame: W96 ] [ Designated as safety issue: No ]Percentage of patients with negative HbsAg at W96, i.e 12 months after a 48 weeks treatment with pegylated interferon
Secondary Outcome Measures:
- Kinetics of HbsAg [ Time Frame: W-6, W0, W12, W24 and W48 ] [ Designated as safety issue: No ]Kinetics of HbsAg under treatment at W-6, W0, W12, W24 and W48 and after discontinuation of PegIFN alpha 2a at W72, W20 and W144
| Enrollment: | 185 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PegIFN + Nucleosidic or Nucleotidic Analog |
Drug: Pegylated interferon-alpha-2a
180 mcg / wk / SC from D0 to W48
|
| Active Comparator: Nucleosidic or Nucleotidic Analog |
Drug: Nucleotidic or Nucleosidic Treatment
Analog treatment according to investigators practice
|
Detailed Description:
The purpose of this study is to provide a therapeutical alternative to the use of an extended or undeterminated duration of treatment with prolonged nucleoside (s)/nucleotide (s)analog (s).
The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations.
It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Positive Hbs Ag
- Negative HbeAg
- Plasma HBV DNA undetectable at pre-inclusion ever since 12 months
- ALT less than or equal to 5 times the upper limit of normal
- Non cirrhotic or Not Decompensated Cirrhosis (Child Pugh <7)
- Undetectable hepatocellular carcinoma in liver scan and / or alpha-fetoprotein rate <50 ng / ml
- Unchanged nucleoside (s) and / or nucleotide (s) treatment for at least three months (and not including telbivudine)
- Negative pregnancy test for childbearing women
- Signed informed consent
- Use of contraception for childbearing women
Exclusion Criteria:
- Polymorphonuclear neutrophils <1500/mm3
- Platelets <70.000/mm3
- Co-infections with HIV, HCV and / or HDV
- Prolonged excessive consumption of alcohol
- Active intravenous drug addiction
- Immunomodulators Treatment(eg interferons), ever since one year
- Immunosuppressive treatments terminated ever since one year
- Telbivudine treatment
- Long course steroid treatment (more than 4 weeks) by oral way
- History of severe epilepsy or current use of anticonvulsants
- Severe heart disease (eg heart failure stage III or IV NYHA class, myocardial infarction less than 6 months, ventricular arrhythmia requiring treatment, unstable angina or other significant cardiovascular disease)
- Chronic liver disease other than HBV-related (hemochromatosis, autoimmune hepatitis, metabolic liver disease, including Wilson's disease and a deficiency of alpha1-antitrypsin deficiency, alcoholic liver disease, exposure to toxins)
- Presence or suspicion of cancer or a history of cancer (except basal cell carcinoma or in situ carcinoma) within 5 years preceding the randomization
- Thyroid uncontrolled disease, abnormal TSH, elevated thyroid antibodies and clinical manifestations of thyroid dysfunction
- History of autoimmune disease (inflammatory digestive, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis ....) Or presence of autoantibodies at a significant rate
- Renal impairment (creatinine clearance <50 ml / min using the Cockroft formula), renal transplantation, hemodialysis
- Hypersensitivity to the active substance, interferon alpha or any component
- History of depression or psychiatric disorders and uncontrolled depression or uncontrolled psychiatric disorders
- Pregnancy or breastfeeding, or wish of pregnancy during the study period.
- Patients under legal protection or unable to express their consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172392
Locations
| France | |
| Hôpital Saint Joseph, Service d'hépatogastroentérologie | |
| Marseille, France, 13008 | |
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Roche Pharma AG
Investigators
| Study Chair: | Marc BOURLIERE, MD | Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille |
More Information
Additional Information:
No publications provided
| Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
| ClinicalTrials.gov Identifier: | NCT01172392 History of Changes |
| Other Study ID Numbers: | 2010-019367-11, ANRS HB 06 PEGAN |
| Study First Received: | July 28, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic 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 Interferon-alpha |
Interferon Alfa-2a Interferons Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013