- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01892241
Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
This study focused on the subsequential antiviral therapeutic strategies for chronic hepatitis B patients with spontaneous decline of HBV DNA after acute exacerbation. Patients fullfilled the following criterias were chosen for screening: They were antiviral treatment naı¨ve and had been positive for hepatitis B surface antigen (HBsAg) for at least 6 months, were positive for HBeAg and had an HBV DNA Level of more than 500,000IU/ml. Their serum alanine aminotransferase level was greater than 2 but less than or equal to 30 times the upper limit of the normal range, their peak value of total bililubin ranged from 2mg/ml to 20mg/ml and the prothrombin time activity was greater than 60%.
ALL of these patients were hospitalized and pretreated with anti-inflammation and liver protection agents such as Stronger Neo-Minophagen C, Polyunsaturated phosphatidylcholine (Essentiale), Ursodeoxycholic Acid and L-Glutathione reduced, without any nuclutide of nucleoside. Their ALT、TBIL and PTA were monitor weekly and HBVDNA level were measured every two weeks. Patients were eligible if their HBVDNA declined spontaneously by 2 log(10) IU/mL while their ALT falled below 10 ULN and TBIL falled below 2mg/ml within 8 weeks of pretreatment.
Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of chronic liver disease should be systematically checked to exclude co-infection with HDV, HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive agents at the time of study were excluded. All patients in this study lived in Guangdong, a province of 100,000,000 populations, with same demographics. Owing to patients fear or refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other clinical methods to obtain equivalent information of patient conditions. In our cases, ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar examination was performed by two experi-enced hepatologists at least three times on each patient.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 180µg of peginterferon alfa-2a
Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
|
180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
Autres noms:
|
Comparateur actif: Entecavir
cases in group B received an continual entecavir therapy(0.5
mg orally once daily)
|
continual entecavir therapy(0.5
mg orally once daily)
|
Aucune intervention: Control group
Those in group C didn't accept any antiviral regiment .
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Complete viralogic response
Délai: week 96
|
Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).
|
week 96
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
HBsAg loss and seroconversion
Délai: week 24,48,72 and 96
|
HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody.
HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only.
|
week 24,48,72 and 96
|
ALT normalization
Délai: week 24,48,72 and 96
|
ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer).
|
week 24,48,72 and 96
|
Sick leave in patients in different groups
Délai: week 48,72 and 96
|
week 48,72 and 96
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Gao Zhiliang, Doctor, The Third Affliated Hospital of Sun Yat-sen University
- Directeur d'études: Zhao Zhixin, Doctor, The Third Affliated Hospital of Sun Yat-sen University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Hépatite, virale, humaine
- Infections à Hépadnaviridae
- Infections par le virus de l'ADN
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite B
- Hépatite
- Hépatite A
- Hépatite B chronique
- Hépatite chronique
- Agents anti-infectieux
- Agents antiviraux
- Peginterféron alfa-2a
- Entécavir
Autres numéros d'identification d'étude
- ATFSHBVD
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