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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01987791
• Other study ID #: HBV-PLT-100
• Status: Unknown status
• Phase: N/A
• First received: November 13, 2013
• Last updated: November 13, 2013
• Start date: January 2005

Study information

• Verified date: November 2013
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 15
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Cirrhosis
• Thrombocytopenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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