Status:
UNKNOWN
Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues on the Hepatitis B Surface Antigen of Virally Suppressed Subjects With Chronic Hepatitis B
Lead Sponsor:
Lai Wei
Conditions:
To Evaluate the Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues in Nucleos(t)Ide-treated Patients With Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
In the globe, about 33% (2 billion) of population has ever been infected with hepatitis B virus (HBV), and about 5% (350-400 million) were chronical HBV infection. In areas with high prevalence of hep...
Eligibility Criteria
Inclusion
- Aged 18-65;
- Males or females;
- Clinically diagnosed as chronic hepatitis B before taking nucleos(t)ide analogues (Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide Fumarate) (HBsAg and/or positive HBV DNA for over 6 months, consistent or recurrent ALT elevation, histology confirmed chronic hepatitis B);
- AST and ALT≤10 x ULN;
- Total bilirubin ≤2 x ULN;
- Having been treated with nucleos(t)ide analogues (Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide Fumarate) for more than 1 year;
- 100IU/ml \< HBsAg \< 1500IU/ml;
- HBV DNA \< 20IU/ml;
- Child-Pugh class A;
- Willing to sign an informed consent form.
Exclusion
- Patients with known allergy to Celecoxib or Sulfonamide;
- Patients with oral aspirin or other NSAIDS (non-steroidal anti-inflammatory drugs) induced asthma, urticaria or anaphylactic reactions;
- Patients treated for perioperative pains post coronary artery bypass graft (CABG);
- Patients with active gastrointestinal ulcer/hemorrhage;
- Patients with severe heart failure;
- Patients with myocardial infarction within 3 months prior to enrollment;
- ALT \>10 x ULN or total bilirubin \>2 x ULN;
- Patients with peripheral leukocyte and/or platelet counts lower than lower limits of normal (LLN);
- Patients with severe diseases of visceral organs (included but not limited cardiovascular, lung, kidney, brain) and fundus lesions;
- Patients with concurrent autoimmune diseases, psychosis, diabetes, thyroid dysfunction (hyperactivity or hypothyroidism);
- Patients with definite or suspected liver cancer or other malignancies;
- Patients with historically organ transplant or ready to undergo organ transplant;
- Patients on immunosuppressants;
- Female patients who are pregnant or intended to become pregnant within 2 years;
- Patients with history of drug or alcohol abuse;
- Child-Pugh class B or C (current or prior onset);
- Patients with concurrent HIV infection;
- Patients with other liver diseases (including but not limited to positive Hepatitis C antibody);
- Patients who are unable or unwilling to provide informed consent form or comply with study requirement.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT05256823
Start Date
February 24 2022
End Date
December 31 2023
Last Update
August 3 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
3
Bejing Tsinghua Changgung Hospital
Beijing, Bejing, China, 100015
4
Tianjin Third Center Hospital
Tianjin, Tianjin Municipality, China, 300170