Pruritus related to cholestasis
Conditions
Interventions
Intervention Group:Eligible subjects were treated with nalfurafine hydrochloride, and the specific dosing regimen was as follows: nalfurafine hydrochloride: 2.5ug/ tablet, once a day, one tablet per d
Sponsors
Tianjin University Central Hospital(Tianjin Third Central Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), with no gender restrictions; 2. Have a history of chronic liver disease (including primary biliary cholangitis, primary sclerosing cholangitis, incomplete biliary obstruction, chronic viral hepatitis, liver cirrhosis, long-term drug-induced cholestasis, and hereditary cholestasis syndromes such as progressive familial intrahepatic cholestasis and benign recurrent intrahepatic cholestasis, etc.) for at least 6 months; 3. Meet the diagnostic criteria for cholestasis 2 (ALP >= 1.5× upper limit of normal (ULN), GGT >= 3×ULN or TBA >= 20 µmol/L); 4. Patients with moderate to severe pruritus (pruritus symptoms lasting more than 2 weeks within 6 months before signing the informed consent, and self-reported severe pruritus (affecting normal social interaction during the day or normal sleep at night), with a VAS score >= 50mm); 5. If liver cirrhosis is present, patients with a Child-Pugh score = 50mm; 8. The number of days with Xie-Chuan Island pruritus severity measured at baseline is more than 5 days, and the number of days with a larger pruritus severity of >= 3 on any day after waking up or before going to bed is more than half.
Exclusion criteria
Exclusion criteria: 1. Patients with liver failure (including acute, subacute, acute-on-chronic or chronic liver failure, according to the Chinese guidelines for the diagnosis and treatment of liver failure); 2. Patients with liver cirrhosis who have hepatic encephalopathy or moderate or more ascites, or whose Child-Pugh score has a score of 3 for albumin or prothrombin activity; 3. Patients with advanced hepatocellular carcinoma; however, patients with early hepatocellular carcinoma with a tumor diameter of 3 cm or less and no more than 3 tumors and a Child-Pugh score of A can be included; 4. Patients with complete biliary obstruction; 5. Patients with a history of allergy to opioid drugs; 6. Patients with atopic dermatitis or chronic urticaria; 7. Patients with chronic renal insufficiency or on dialysis; 8. Patients with drug abuse or alcohol abuse; 9. Patients with uncontrollable fungal, bacterial, viral or other infections, including those receiving anti-tuberculosis treatment for pulmonary tuberculosis or those known to be infected with human immunodeficiency virus (HIV); 10. Patients who have received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 12 weeks before screening; 11. Patients with poorly controlled hypertension by drug treatment: systolic blood pressure >= 180 mmHg, diastolic blood pressure >= 110 mmHg; 12. Patients who have started or adjusted drugs that may affect the judgment of pruritus efficacy within 2 weeks before screening, including but not limited to antipsychotic drugs, sedative-hypnotics, selective serotonin reuptake inhibitors (SSRIs), anti-anxiety drugs or tricyclic antidepressants, antihistamines, calcineurin inhibitors, gabapentin, pregabalin, and other restricted concomitant drugs or those who are expected to change their treatment plan during the study period; 13. Patients currently using glucocorticoids or immunosuppressants (except for topical use); 14. Patients who have received phototherapy for pruritus within 1 month before screening; 15. Patients who have participated in other clinical trials (including medical device clinical trials) within 1 month before screening and received investigational drug administration or clinical trial device treatment; 16. Patients with mental illness or intellectual disability who cannot accurately describe their own feelings; 17. Pregnant women, lactating women, women with positive pregnancy tests, or those who do not agree to take contraceptive measures during the study period; 18. Patients who, in the judgment of the investigator, are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of VAS score after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of VAS score after 2, 4, 8 and 12 weeks of treatment;The proportion of patients whose VAS scores decreased by more than or equal to 30mm from the baseline after 2, 4, 8 and 12 weeks of treatment;The proportion of patients whose VAS scores decreased by more than or equal to 50% from the baseline after 2, 4, 8 and 12 weeks of treatment;The changes of pruritus score based on the Xie Kawashima pruritus severity evaluation method after 2, 4, 8 and 12 weeks of treatment were compared with the baseline;After 2, 4, 8 and 12 weeks of treatment, the proportion of patients with a decrease of 1 point in the pruritus score based on the Xie Kawashima pruritus severity evaluation method was compared with that at baseline;Changes from baseline in quality of life score 40 (PBC-40) after 4, 8 and 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLiang Jing
Tianjin University Central Hospital(Tianjin Third Central Hospital)
Outcome results
None listed