Contact information
Type
Scientific
Primary contact
Prof Michael P Manns
ORCID ID
Contact details
Medizinische Hochschule Hannover
Dept. for Gastroenterology
Hepatology
and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
+49 511 5323306
manns.michael@mh-hannover.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MHH-GHE- 3298
Study information
Scientific title
Acronym
GIHALT Study
Study hypothesis
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
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)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hepatitis C reinfection after liver transplantation
Intervention
Administration of pegylated interferon alfa-2a plus ribavirin versus no therapy.
Intervention type
Drug
Phase
Not Specified
Drug names
Pegylated interferon alfa-2a and ribavirin
Primary outcome measures
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 trial start date
01/05/2004
Overall trial end date
23/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75
Participant 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
Recruitment start date
01/05/2004
Recruitment end date
23/09/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Medizinische Hochschule Hannover
Hannover
30625
Germany
Sponsor information
Organisation
Hannover Medical School (Medizinische Hochschule Hannover) (Germany)
Sponsor details
Dept. for Gstroenterology
Hepatology
and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Hannover Medical School (Medizinische Hochschule Hannover) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary