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
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
2 other identifiers
interventional
185
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2010
CompletedFirst Posted
Study publicly available on registry
July 29, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 29, 2013
February 1, 2013
4.4 years
July 28, 2010
March 28, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
HbsAg negativation at week 96
Percentage of patients with negative HbsAg at W96, i.e 12 months after a 48 weeks treatment with pegylated interferon
W96
Secondary Outcomes (1)
Kinetics of HbsAg
W-6, W0, W12, W24 and W48
Study Arms (2)
PegIFN + Nucleosidic or Nucleotidic Analog
EXPERIMENTALNucleosidic or Nucleotidic Analog
ACTIVE COMPARATORInterventions
180 mcg / wk / SC from D0 to W48
Analog treatment according to investigators practice
Eligibility Criteria
You may qualify if:
- Positive Hbs Ag
- Negative HbeAg
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Roche Pharma AGcollaborator
Study Sites (1)
Hôpital Saint Joseph, Service d'hépatogastroentérologie
Marseille, 13008, France
Related Publications (1)
Bourliere M, Rabiega P, Ganne-Carrie N, Serfaty L, Marcellin P, Barthe Y, Thabut D, Guyader D, Hezode C, Picon M, Causse X, Leroy V, Bronowicki JP, Carrieri P, Riachi G, Rosa I, Attali P, Molina JM, Bacq Y, Tran A, Grange JD, Zoulim F, Fontaine H, Alric L, Bertucci I, Bouvier-Alias M, Carrat F; ANRS HB06 PEGAN Study Group. Effect on HBs antigen clearance of addition of pegylated interferon alfa-2a to nucleos(t)ide analogue therapy versus nucleos(t)ide analogue therapy alone in patients with HBe antigen-negative chronic hepatitis B and sustained undetectable plasma hepatitis B virus DNA: a randomised, controlled, open-label trial. Lancet Gastroenterol Hepatol. 2017 Mar;2(3):177-188. doi: 10.1016/S2468-1253(16)30189-3. Epub 2017 Jan 20.
PMID: 28404133DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc BOURLIERE, MD
Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2010
First Posted
July 29, 2010
Study Start
January 1, 2011
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 29, 2013
Record last verified: 2013-02