Observation Study of Prednisone and Cyclosporine in Treatment of Thrombocytopenia in Hepatitis B Cirrhosis

N/AUnknownNCT01987791

Peking University People's Hospital15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thrombocytopenia Hepatitis B Cirrhosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

treatment failure

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.

Time frame: 12 months

Secondary Outcomes

proportion of patients with a complete platelet count response

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

Time frame: at 4 weeks, at 6 months , and at 12 months

proportion of patients with an overall platelet count response

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

Time frame: at 4 weeks, at 6 months , and at 12 months

Data from ClinicalTrials.gov

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