Condition category
Infections and Infestations
Date applied
05/08/2005
Date assigned
09/09/2005
Last edited
07/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mh-hannover.de/index.php?id=2&L=1

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

Publication citations

Additional files

Editorial Notes