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

Comparison of Prednisone and Cyclosporine in the Treatment of Thrombocytopenia in Patients With Cirrhosis Associated With Hepatitis B in China: a Collaborative, Open-label, Real World Observational Study

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 Overview

• Status: Unknown
• Conditions: Hepatitis B; Thrombocytopenia; Cirrhosis

• Study Type: Observational
• Enrollment (Anticipated): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients were enrolled from 15 centers in China from January 1, 2005 to September 31, 2013.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at 4 weeks, at 6 months , and at 12 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): November 1, 2013
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (Estimate): November 19, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Hematologic Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Blood Platelet Disorders; Fibrosis; Hepatitis B; Hepatitis; Hepatitis A; Liver Cirrhosis; Thrombocytopenia
• Other Study ID Numbers: HBV-PLT-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No