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

Completed

• Conditions: Hepatitis C reinfection after liver transplantation; Infections and Infestations; Chronic viral hepatitis

• Registration Number: ISRCTN51477478
• Lead Sponsor: Hannover Medical School (Medizinische Hochschule Hannover) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

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

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 <40 ml/min
12. Hemoglobin <10 g/dl (females), <11 g/dl (males)
13. Hepatocellular carcinoma within 2 months prior to randomization
14. Neutrophils <1500/µl
15. Leukozytes >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained viral clearance (HCV RNA negative, 24 weeks after the end of treatment).

Secondary Outcome Measures

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