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
| ISRCTN | ISRCTN51477478 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51477478 |
| Secondary identifying numbers | MHH-GHE- 3298 |
- Submission date
- 05/08/2005
- Registration date
- 09/09/2005
- Last edited
- 07/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael P Manns
Scientific
Scientific
Medizinische Hochschule Hannover
Dept. for Gastroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| Phone | +49 511 5323306 |
|---|---|
| manns.michael@mh-hannover.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GIHALT Study |
| Study objectives | Currently, only retrospective reports on the use of pegylated interferon and ribavirin after liver transplantation are available. The study aims to evaluate efficacy and safety of this approach in a prospective, controlled, multi-center protocol. Please note that, as of 05/11/2008, the end date of this trial has been updated from 31/12/2008 to 23/09/2008. |
| Ethics approval(s) | The study was approved by the Ethics Committee of the Hannover Medical School (Ethik-Kommission der Medizinische Hochschule Hannover) on the 6th of November 2003 (ref: 3298) |
| Health condition(s) or problem(s) studied | Hepatitis C reinfection after liver transplantation |
| Intervention | Administration of pegylated interferon alfa-2a plus ribavirin versus no therapy. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pegylated interferon alfa-2a and ribavirin |
| Primary outcome measure | Sustained viral clearance (HCV RNA negative, 24 weeks after the end of treatment). |
| Secondary outcome measures | 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) |
| Overall study start date | 01/05/2004 |
| Completion date | 23/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 23/09/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Medizinische Hochschule Hannover
Hannover
30625
Germany
30625
Germany
Sponsor information
Hannover Medical School (Medizinische Hochschule Hannover) (Germany)
University/education
University/education
Dept. for Gstroenterology, Hepatology, and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| Website | http://www.mh-hannover.de/index.php?id=2&L=1 |
|---|---|
"ROR" |
https://ror.org/00f2yqf98 |
Funders
Funder type
University/education
Hannover Medical School (Medizinische Hochschule Hannover) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
