Phase
Condition
Scar Tissue
Hyponatremia
Hepatic Fibrosis
Treatment
Sulfasalazine enteric-coated tablets
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the informed consent form before the trial and be able to complete the study inaccordance with the requirements of the trial protocol;
The age is 18
70 years old (including boundary value), the weight of male subjectsis not less than 45 kg, and the weight of female subjects is not less than 40 kg.Body mass index (BMI) in the range of 1832kg/m2 (including critical value);Enrolled patients also need to meet:
A:Patients with PBC cirrhosis PBC patients who have been treated and show an inadequate response to UDCA:(1) according to the biochemical response criteria for 2021 PBC, Enrolled patients need to meet the criteria of ALP ≥1.67 × ULN as a poor biochemical response to UDCA after 12 months of UDCA treatment; (2) meeting the diagnostic criteria for primary cholangitis (PBC) , i.e. meeting at least two of the following criteria: 1.indicators of cholestasis such as elevated Alkaline phosphatase; 2.Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive .3 liver biopsy consistent with PBC; Patients with newly diagnosed primary cholangitis (PBC-RRB- met the diagnostic criteria of at least two of the following): 1.indicators of cholestasis such as elevated Alkaline phosphatase; 2.Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive 3. liver biopsy consistent with PBC; B:Patients with hepatitis B cirrhosis Diagnosis of hepatitis B cirrhosis based on clinical history, histology or imaging.
C:Patients with hepatitis C cirrhosis Diagnosis of hepatitis C cirrhosis based on clinical history, histology or imaging.
D:Alcoholic hepatitis cirrhosis Diagnosis of alcoholic cirrhosis based on clinical history, histology, or imaging.
Exclusion
Exclusion Criteria:
Those who have a history of allergies in the past, or the investigator suspects thatthey are allergic to the active ingredients of the drug or their excipients understudy;
Allergy to sulfasalazine and its metabolites, sulfonamides or salicylic acid;
Patients with intestinal obstruction or urinary tract obstruction;
Patients with porphyria, such as sulfonamides, have been reported to cause acuteattacks.
Acute and chronic liver disease with clinical significance caused by infectionsother than HBV, HCV, PBC, and alcoholic liver disease;
Primary liver cancer; alpha-fetoprotein (AFP) greater than 50 ug/L or imagingsuggests malignant liver mass; Those with other malignancies or a history of othermalignancies in the 5 years prior to screening (except for complete remission ofmalignant tumors after treatment and no additional medical or surgical interventionwithin 3 years prior to screening);
The investigator judged that there is impaired gastrointestinal function orgastrointestinal diseases that may affect the absorption of oral drugs, such assevere gastric ulcer, erosive gastritis, partial gastrectomy, and persistent >Grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhoea);
Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune,psychiatric, neurological, renal and other systems;
Those who have had major trauma or undergone major surgery within 3 months beforescreening; or those who plan to undergo surgery during the study;
Donated blood or lost blood ≥ 400mL within 3 months before screening, or receivedblood transfusion; or ≥ blood donation or blood loss within 1 month prior toscreening 200mL;
Those who are positive for AIDS antigen/antibody, positive for Treponema pallidumantibody and positive RPR test;
History of drug dependence or drug abuse within 1 year prior to screening;
Participate in clinical trials of other investigational drugs or medical deviceswithin 3 months before screening, and take experimental drugs or use them Those whohave medical devices;
Those who have a positive pregnancy test during lactation or screening, or who havefertility requirements in the past two years;
Subjects who the investigator believes have other factors that are not suitable toparticipate in this trial.
Study Design
Study Description
Connect with a study center
Chongqing
Chongqing, Chongqing 400000
ChinaActive - Recruiting
Chongqing Medical University
Chongqing, Chongqing 400000
ChinaActive - Recruiting
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