The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Sponsor||Third Affiliated Hospital, Sun Yat-Sen University|
|Start date||August 2016|
|End date||August 2017|
|Trial size||200 participants|
|Trial identifier||NCT02893124, I-Cure-3|
HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(＜0.05 IU/mL).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 96 weeks
time frame: 96 weeks
Male or female participants from 18 years up to 65 years old.
- CHB patients who had received single NAs for more than 12 months and had a history of NAs drug resistance or suboptimal/partial virological response.
- Hepatitis B e antigen (HBeAg)-negative.
- Hepatitis B surface antigen (HBsAg) positive and <1000 IU/mL.
- Hepatitis B virus DNA <100 IU/mL.
- Patients with liver cirrhosis, Hepatocellular Carcinoma or alpha feto protein (AFP) >2 upper limit of normal(ULN) or other malignancies.
- Patients with other factors causing liver diseases.
- Pregnant and lactating women.
- Patients with concomitant HIV infection or congenital immune deficiency diseases.
- Patients with diabetes, autoimmune diseases.
- Patients with important organ dysfunctions.
- Patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.)
- Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
- Patients with a previous use of IFN anti hepatitis B virus treatment.
- Patients who can't come back to clinic for follow-up on schedule.
|Official title||The Optimizing Treatment of Peginterferon Alpha in HBeAg-negative Chronic Hepatitis B Virus Patients With Low Level HBsAg|
|Description||It is estimated that more than 400 million people are infected with hepatitis B virus (HBV) globally. HBeAg-negative CHB patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled in the out-patient department of 3rd Affiliated Hospital of Sun Yat-sen University. All of them were HBsAg positive and anti-HBs negative for more than 6 months with HBV DNA<100 IU/mL and HBsAg levels <1000 IU/mL. All patients did not have other liver diseases and contraindications for interferon therapy. After giving informed consent, patients were treated with NAs once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. The use of other immune suppressive or regulatory drugs and other antiviral drugs was prohibited during the course of the study. In this study, treatment endpoint was HBsAg loss(＜0.05 IU/mL).Anti-HBs positive(＞10 milli-International unit)(mIU/mL) defined as seroconversion. Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in case of nonresponse.|
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