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

Peking University

Status: Unknown

Conditions: Thrombocytopenia; Cirrhosis; Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT01987791

HBV-PLT-100

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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