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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Brief Summary

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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

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Conditions

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Thrombocytopenia Hepatitis B Cirrhosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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HBV-PLT-100

Identifier Type: -

Identifier Source: org_study_id