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

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ClinicalTrials.gov Identifier: NCT01987791
Recruitment Status : Unknown
Verified November 2013 by Peking University People's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Thrombocytopenia Hepatitis B Cirrhosis

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. treatment failure [ Time Frame: 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 :
  1. proportion of patients with a complete platelet count response [ Time Frame: 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

  2. proportion of patients with an overall platelet count response [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
whole blood


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients were enrolled from 15 centers in China from January 1, 2005 to September 31, 2013.
Criteria

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
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01987791    
Other Study ID Numbers: HBV-PLT-100
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Cirrhosis
Thrombocytopenia
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases