HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients
This trial is active, not recruiting.
|Condition||chronic hepatitis b (hbeag-negative)|
|Treatment||pegylated interferon alfa-2a|
|Sponsor||José Antonio Carrion|
|Collaborator||Instituto de Salud Carlos III|
|Start date||January 2015|
|End date||December 2017|
|Trial size||116 participants|
|Trial identifier||NCT02743182, QUANTI-B|
Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.
|Intervention model||parallel assignment|
Number of patients with HBsAg loss
time frame: 1 year after treatment completion
Male or female participants at least 18 years old.
Inclusion Criteria: - Chronic hepatitis B (HBeAg-negative) - Signed inform consent - Aged > 18 Exclusion Criteria: - Contraindications for Pegylated interferon (cirrhosis, pregnancy, others) - Previous treatment with interferon or Pegylated interferon - Previous HBsAg loss - Treatment duration with Nucleos(t)ide analogues less than 2 years - Poor adherence to Nucleos(t)ide analogues
|Official title||HBsAg Loss Adding Pegylated Interferon Alfa-2a in HBeAg-negative Patients Treated With Nucleos(t)Ide Analogues.|
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