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 (0)511 5323306
manns.michael@mh-hannover.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3272
Study information
Scientific title
Acronym
HCV III study
Study hypothesis
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
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)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/04/2004
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
135 (as of 08/11/10, previously: 150) (Recruitment completed, last patient visit on 27/09/2011).
Participant 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
Recruitment start date
01/04/2004
Recruitment end date
31/12/2011
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 Gastroenterology
Hepatology
and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
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).
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23523674
Publication citations
-
Results
Deterding K, Grüner N, Buggisch P, Wiegand J, Galle PR, Spengler U, Hinrichsen H, Berg T, Potthoff A, Malek N, Großhennig A, Koch A, Diepolder H, Lüth S, Feyerabend S, Jung MC, Rogalska-Taranta M, Schlaphoff V, Cornberg M, Manns MP, Wedemeyer H, , Delayed versus immediate treatment for patients with acute hepatitis C: a randomised controlled non-inferiority trial., Lancet Infect Dis, 2013, 13, 6, 497-506, doi: 10.1016/S1473-3099(13)70059-8.