Combination therapy using pegylated interferon alfa-2a and ribavirin in patients with chronic hepatitis C virus (HCV) infection 3 to 120 months after liver transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51477478

Enrollment

Registered

2005-09-09

Start date

2004-05-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Hepatitis C reinfection after liver transplantation Infections and Infestations Chronic viral hepatitis

Interventions

Administration of pegylated interferon alfa-2a plus ribavirin versus no therapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males, females above the age of 18 2. HCV reinfection after liver transplantation 3. 3 to 120 months after liver transplantation 4. Histology showing hepatitis 5. Negative pregnancy test 6. Willingness to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Histology showing acute or chronic rejection 2. Hypersensivity to ribavirin, interferon 3. HCV-positive donor 4. Pretreatment with pegylated interferon plus/minus ribavirin 5. Pretreatment with interferon plus ribavirin 6. Pregnancy 7. Active cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis A virus (HAV) infection 8. Liver cirrhosis, Child Pugh stages B or C 9. Alpha fetoprotein >100 ng/m 10. Bilirubin >3.0 mg/d 11. Creatinine clearance 11,000/µl 16. Platelets <75,000/µl 17. Patients at special risk for anemia 18. Patients at special risk for complications induced by anemia 19. Autoimmune disease 20. Functionally relevant chronic lung disease 21. Severe cardiovascular disease 22. Psychiatric disease, especially depression 23. Epilepsy 24. Carcinoma 25. Difficult to treat thyroid disease 26. Retinopathy 27. Difficult to treat diabetes mellitus 28. Active drug abuse, including alcohol abuse

Design outcomes

Primary

Measure	Time frame
Sustained viral clearance (HCV RNA negative, 24 weeks after the end of treatment).	—

Secondary

Measure	Time frame
1. Biochemical response (normal alanine aminotransferase [ALT], 24 weeks after the end of treatment) 2. On treatment virological response (HCV RNA negative after 12, 24, 48 weeks) 3. On treatment biochemical response (ALT normal after 12, 24, 48 weeks) 4. Histological response (24 weeks after the end of treatment)	—

Countries

Germany

Outcome results

None listed

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