Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Hepatitis B Clinical Trial

Official title:

Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01720238
• Other study ID #: D1211000039120003
• Status: Active, not recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: July 27, 2015
• Start date: March 2012
• Est. completion date: December 2018

Study information

• Verified date: July 2015
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial Summary

Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 621
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• written informed consent

• aged 18-70 years

• clinical diagnosis of compensated liver cirrhosis

1. liver biopsy showing cirrhosis

2. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension

3. if no biopsy or endoscopy ,should meet two of the four:

• Imaging(US, CT or MRI, et al) showing Surface nodularity: Echogenecity (spleen pachydiameter > 4.0cm or> 5 costal region)

• PLT < 100×10 < 9 >/L,no other interpretation

• ALB < 35.0 g/L, or INR > 1.3, or CHE < 5.0KU/L

• Liver stiffness measurement value > 12.4 kpa

• HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL

Exclusion Criteria:

• patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy

• allergic to any ingredients of the drugs

• patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease.

• AFP > 100ng/ml or Cr > 1.5×ULN

• pregnant woman

• patient with severe disease or other organ failure

• patient with any tumors

• patient with sever mental disease.

• patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis B
• Liver Cirrhosis

Intervention

Drug:
• Entecavir
0.5mg qd
• Lamivudine plus Adefovir Dipivoxil
Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

Locations

Country	Name	City	State
China	Beijing 302 Hospital	Beijing	Beijing
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Beijing YouAn Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	PeKing University People's Hopital	Beijing	Beijing
China	The First Hospital of Peking University	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing 302 Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Beijing YouAn Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decompensation rate of liver cirrhosis	presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC	3 years	No
Secondary	child-pugh score		1,2 and 3 years	No
Secondary	HBVDNA undetected		1,2 and 3 years	No
Secondary	liver elasticity		1, 2, and 3 years	No
Secondary	life quality score		1, 2 and 3 years	No
Secondary	cost-effectiveness		1, 2 and 3 years	No