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Lamivadin plus adefovir compared with entecavir decompensated HBV-related cirrhosis: a prospective randomized controlled trial

Lamivadin plus adefovir compared with entecavir decompensated HBV-related cirrhosis: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001012
Enrollment
Unknown
Registered
2010-09-11
Start date
2010-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ordecompensated HBV-related cirrhosis

Interventions

A:Lamivadin & Adefovir

Sponsors

The First Affiliated Hospital of Wenzhou Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Men and women patients are adults aged 18 to 65 years with hepatitis B virus related cirrhosis; 2. Evidence of active viral replication was documented by a positive test for HBV-DNA in serum; 3. Liver cirrhosis was proven by ultrasound or CT; 4. Decompensated cirrhosis was evidenced by a Child-Pugh score >= 7; 5. Patients had decompensation signs such as jaundice, ascites, variceal bleeding, and hepatic encephalopathy.

Exclusion criteria

Exclusion criteria: 1. Breastfeeding or pregnant women; 2. Use of interferon, immunomodulator, or any nucleoside analog that is active against hepatitis virus within 6months before enrollment; 3. Epilepsy or using any anti-epileptic drug; 4. Any immunologically mediated disease; 5. Malignant disease, including HCC; 6. Evidence of unstable or conspicuous angiocardiopathy such as angina cordis,heart failure,recent myocardial infarction and severe hypertension; 7. Long exposure to the hepatotoxin, such as excessive drinking(drinking greater than 14 alcohol units for more than 1 year, and 1 alcohol unit just as 1 jar of beer, or 1 cup of wine, or 1 pocillum of firewater) and drug taking; 8. Thyroid disease and diabetes that are not well controlled by drugs; 9. Liver disease that was not due to hepatitis b, as alcoholic liver disease, HCV, autoimmune disease, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson’s disease; 10. Co-infection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV; 11. Severe kidney disease; 12. Organ transplantation (except corneal and hair transplantation); 13. Recent treatment with systemic corticosteroids; 14. Any factor that will interfere the patient to participate or complete the study.

Design outcomes

Primary

MeasureTime frame
HBVM;HBVDNA;liver function;

Secondary

MeasureTime frame
kidney function;CK;

Countries

China

Contacts

Public ContactMingqin Lu
hongliu180@126.com+86 577 88078232

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026