Clinical trial NCT02894918: A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs
Official title: A Randomized, Open-label, Multi-center Clinical Trial to Evaluate Addition of Peginterferon Alfa-2a to CHB Patients Treated With NAs and Achieved HBV DNA<15 IU/ml、HBeAg<100 PEIU/ml、HBsAg Positive and HBsAg<1500 IU/ml.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates whether addition of Peginterferon alfa-2a to CHB Patients Treated with nucleoside analogues (NAs) can enhance the rate of HBsAg clearance at end of treatment. This study is a Randomized, open-label, multi-center study.

The CHB patients with NAs treatment and have achieved HBV DNA \<15 IU/ml、HBeAg \<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml will be randomized into 2 groups:

Group 1 (Combination group): Maintain NAs treatment while add 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 (Mono NA group) : Maintain NAs treatment for 49 weeks. Note: NAs including: LAM, ADV, ETV, or TDF.


Eligibility criteria: Inclusion Criteria:

* Male and female patients \>18 and ≤65 years of age;
* Diagnosed chronic hepatitis B (HBsAg(+) for over 6 months before nucleos(t)ide analogues treatment)
* Patients had achieved HBV DNA\<15 IU/ml、HBeAg\<100 PEIU/ml、HBsAg positive and HBsAg\<1500 IU/ml on treatment of Nucleoside (acid) Analogues (including LAM, ADV, ETV, and TDF )

Exclusion Criteria:

* Decompensated liver disease: including ascites, hepatic encephalopathy, esophagogastric-varicosis and fissure bleeding and other decompensated complication;
* Hypersensitive to interferon(IFN) or its active substance, and ineligible to IFN;
* A history of immunoregulation drug therapy within 1 year before entry including IFN and so on;
* Coinfection with HAV、HCV、HDV、HEV 、HIV or with Other chronic liver diseases such as Alcoholic Liver Disease,Inherited Metabolic Liver Disease,Drug induced Liver Disease and nonalcoholic fatty liver, autoimmune disease including autoimmune hepatitis and Psoriasis and so on;
* Hepatocellular carcinoma(HCC) or alpha feto protein(AFP) levels more than 100ng/ml and Hepatic malignant potential of Imaging examination or AFP levels more than 100 ng/ml for 3 months;
* A neutrophil count of less than 1500 per cubic millimeter or a platelet count of less than 90,000 per cubic millimeter;
* A serum creatinine level that was more than 1.5 times the upper limit of the normal range;
* With other malignant tumors(exclude the cured ones);
* Severe organ dysfunction;
* With severe psychiatric condition or nervous disease such as epilepsy, depression, mania, epilepsy, schizophrenia and so on;
* Uncontrolled diabetes, hypertension or thyroid disease;
* Pregnant women and lactating women or patients with pregnancy plans and not willing to use contraception during the study period;
* Participate in other clinical studies at the same time;
* Patients unsuitable for the research;

Primary outcomes:
measure: The rate of HBsAg loss
timeFrame: 48 weeks
Secondary outcomes:
measure: Decline of HBeAg quantification
timeFrame: 12 weeks, 24 weeks, 48 weeks of treatment
measure: Decline of HBsAg quantification
timeFrame: 12 weeks, 24 weeks, 48 weeks of treatment
measure: The rate of HBeAg loss
timeFrame: 48 weeks
measure: The rate of HBeAg seroconversion
timeFrame: 48 weeks
measure: The rate of HBsAg seroconversion
timeFrame: 48 weeks
measure: Sustained virological response rate
timeFrame: 12 weeks, 24 weeks, 48 weeks of treatment
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: Kaifeng Central Hospitl
state: Henan
city: Kaifeng
country: China
facility: Weishi County People's Hospital
state: Henan
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Henan
city: Shangqiu
country: China
facility: Shangqiu No.1 People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan People's Hospital
state: Henan
Study officials:
affiliation: Henan People's hospital
name: Jia Shang, M.D.
role: PRINCIPAL_INVESTIGATOR
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