Cirrhosis, Hepatitis B, Thrombocytopenia
Conditions
Brief summary
To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis.
Interventions
None listed
Sponsors
Peking University People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed HBV-associated cirrhosis * had an serum HBV DNA level of more than 500 IU per milliliter * have compensated liver cirrhosis * thrombocytopenia (defined as a platelet count of \<30,000 per cubic millimeter) * accompanied with bleed tendency (including petechial, episxias, ecchymosis, hemoptysis, hematemesis and hematochezia) * have a liver-biopsy specimen indicative of cirrhosis, ultrasonography and/or computed tomographic imaging evidence of cirrhosis, or endoscopic evidence of portal hypertension(splenomegaly, ascites, and esophageal varicose)
Exclusion criteria
* pregnant * hepatocellular carcinoma * decompensated cirrhosis * coagulation function abnormal * had a history of other disease (e.g. aplastic anemia, autoimmune disease, idiopathic thrombocytopenia et al) that could induced thrombocytopenia * co-infected with the human immunodeficiency virus * co-infected with hepatitis C virus * co-infected with hepatitis D virus * had a coexisting serious medical or psychiatric illness * serum creatinine level was more than 1.5 times the upper limit of the normal range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment failure | 12 months | The primary efficacy outcome was treatment failure, defined as the composite of (1) any platelet count below 50×109/L after four weeks treatment; (2) significant bleeding, defined as grade 2 severity from any anatomical site as per the ITP bleeding scale that defines bleed grades (0, none; 1, mild; or 2, marked) by objective criteria of 9, based on events that occurred since the last study visit; or (3) rescue treatment administered because of severe thrombocytopenia, bleeding, or a planned invasive procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patients with a complete platelet count response | at 4 weeks, at 6 months , and at 12 months | Secondary end points included proportion of patients with a complete platelet count response (platelet count of ≥ 100×109/L) without rescue treatment at 4 weeks, at 6 months , and at 12 months |
| proportion of patients with an overall platelet count response | at 4 weeks, at 6 months , and at 12 months | Secondary end points included proportion of patients with an overall platelet count response (platelet count of ≥ 30×109/L with doubling from baseline) without rescue treatment at 4 weeks, at 6 months , and at 12 months |
Outcome results
None listed