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| ID | Type | Description | Link |
|---|---|---|---|
| ANRS HB 06 PEGAN | Other Identifier | FrenchAIDS |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIFN + Nucleosidic or Nucleotidic Analog | Experimental |
| |
| Nucleosidic or Nucleotidic Analog | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon-alpha-2a | Drug | 180 mcg / wk / SC from D0 to W48 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetics of HbsAg | 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 | W-6, W0, W12, W24 and W48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc BOURLIERE, MD | Hôpital Saint Joseph, Service d'hépatogastroentérologie, Marseille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph, Service d'hépatogastroentérologie | Marseille | 13008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28404133 | Derived | 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. |
| Label | URL |
|---|---|
| French National Agency for Research on AIDS and viral hepatitis website | View source |
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| Nucleotidic or Nucleosidic Treatment | Drug | Analog treatment according to investigators practice |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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