Condition category
Infections and Infestations
Date applied
03/08/2005
Date assigned
09/09/2005
Last edited
08/11/2013
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 (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 measures

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

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

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

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23523674

Publication citations

  1. 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.

Additional files

Editorial Notes