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

• Conditions: Hepatitis B; Cirrhosis; Thrombocytopenia

• Registration Number: NCT01987791
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Last Update Submitted: 2013-11-13
• Study First Posted: 2013-11-19
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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