Treatment of acute hepatitis C infection: immediate therapy of all patients with peg-interferon alpha-2b alone versus delayed therapy of patients not eliminating hepatitis C virus (HCV) spontaneously with peg-interferon alpha-2b plus ribavirin
| ISRCTN | ISRCTN88729946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88729946 |
| Secondary identifying numbers | 3272 |
- Submission date
- 03/08/2005
- Registration date
- 09/09/2005
- Last edited
- 08/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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 (0)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) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | HCV III study |
| Study objectives | Efficacy of immediate therapy of acute hepatitis C infection is comparable to the efficacy of delayed therapy of patients that do not eliminate HCV spontaneously. Please note that, as of 07/11/2008, the anticipated end date of this trial has been updated from 31/12/2007 to 31/12/2010. Please note that, as of 24/01/2012, the anticipated end date of this trial has been updated from 31/12/2010 to 31/12/2011. |
| Ethics approval(s) | The study was approved by the Ethics Committee of the Hannover Medical School (Ethik-Kommission der Medizinische Hochschule Hannover) on 22/08/2003 (ref: 3272) |
| Health condition(s) or problem(s) studied | Acute hepatitis C |
| Intervention | Please note that as of 08/11/10 the end date of this trial has been extended from 31/12/10 to 31/12/11. Recruitment finished in 09/09/10 Administration of peg-interferon alpha-2b subcutaneously (sc)versus administration of peg-interferon alpha-2b plus ribavirin orally (po) for 24 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | peg-interferon alpha-2b and ribavirin |
| Primary outcome measure | HCV virological response (HCV RNA negative) 84 weeks after randomisation or 24 weeks after the end of treatment |
| Secondary outcome measures | 1. Biochemical response (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] levels) 2. Severity and frequency of adverse events 3. Rate of spontaneous clearance of HCV 4. Quality of life during acute HCV infection and during treatment 5. Evaluation of HCV-specific CD4+ and CD8+ T cell responses and humoral immune responses |
| Overall study start date | 01/04/2004 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 135 (as of 08/11/10, previously: 150) (Recruitment completed, last patient visit on 27/09/2011). |
| Key inclusion criteria | 1. Patients with acute HCV infection and detectable HCV RNA 2. More than 18 years 3. Compensated liver disease 4. Negative urine or blood pregnancy test 5. Willingness to give written informed consent |
| Key exclusion criteria | 1. Other possible reasons for acute HCV infection 2. Liver cirrhosis 3. Pregnancy or breast feeding 4. Previous antiviral therapy with interferon or ribavirin 5. Positive test results for anti hepatitis A virus (HAV) IgM antib., HBsAg, anti-HBc IgM antib., HBeAg, anti human immunodeficiency virus (HIV) 6. History or evidence for chronic liver disease 7. History of severe psychiatric disease, thyroid dysfunction poorly controlled 8. History or evidence for severe illness 9. Drug use within 6 mionths prior to first dose of study drug |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 31/12/2011 |
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 Gastroenterology, 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
Government
Federal Ministry of Education and Research, network of competence for hepatitis (Kompetenznetz Hepatitis; http://www.kompetenznetz-hepatitis.de/about-hep-net/about-hep-net?set_language=en), c/o 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
