Condition category
Infections and Infestations
Date applied
03/08/2005
Date assigned
09/09/2005
Last edited
02/02/2011
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
Department for Gastroenterology
Hepatology and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
+49 5115323306
manns.michael@mh-hannover.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3388

Study information

Scientific title

Acronym

Delta Study

Study hypothesis

Peg-interferon alpha-2a or adefovir lead to sustained virological response in 20-40% of the cases in chronic delta hepatitis.

Ethics approval

Not provided at time of registration

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

Condition

Adults with chronic delta hepatitis

Intervention

A: Adefovir dipivoxil, 10 mg, orally (po) for 48 weeks
versus
B: Pegylated interferon alpha-2a, 180 µg subcutaneously (sc), plus placebo for 48 weeks
versus
C: Pegylated interferon alpha-2a, 180 µg sc, plus adefovir dipivoxil, 10 mg po for 48 weeks; biopsy at the end of treatment

Intervention type

Drug

Phase

Not Specified

Drug names

Peg-interferon alpha-2a, adefovir dipivoxil

Primary outcome measures

Response rate of normal ALT and HDV RNA negativity at the end of treatment (ETR)

Secondary outcome measures

1. Response rate of normal ALT and HDV RNA negativity at the end of follow-up (EOF)
2. Suppression of hepatitis B virus (HBV) DNA below 1x10^5 copies/ml at ETR and EOF
3. Paired biopsy comparison
4. HBsAg levels, loss of HBsAg and HBs Antibodies at ETR and EOF
5. HBV and HDV specific T cell response
6. Saftey (adverse events, vital signs, clinical laboratory parameters)

Overall trial start date

01/04/2004

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Positive Hepatits B surface Antigen (HBsAg)
3. Positive anti-hepatitis D virus (HDV) antibodies
4. Positive HDV-Ribonucleic Acid (RNA) by Polymerase Chain Reaction (PCR)
5. Serum alanine aminotransferase (ALT) >upper limit of normal (ULN) but <10 x ULN
6. Liver biopsy demonstrating liver disease consistent with chronic heaptitis
7. Liver imaging for patients with cirrhosis or marked fibrosis to rule out hepatic carcinoma
8. Negative urine or serum pregnancy test
9. Willingness to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

69

Participant exclusion criteria

1. Antiviral therapy in previous six months
2. Positive tests for hepatitis A virus (HAV) Immunoglobulin M (IgM) antibodies, hepatitis C virus (HCV) RNA or HCV antibodies or Human Immunodeficiency Virus (HIV) antibodies
3. Serum total bilirubin >2 x ULN
4. Decompensated liver disease Child B-C
5. Other reasons for chronic liver disease
6. Haemoglobin <11.5 g/dl for females and <12.5 g/dl for males
7. White blood cell count (WBC) <3000 cells/mm^3
8. Serum creatinine >1.5 x ULN
9. Relevant psychiatric diseases
10. Drug or alcohol abuse within one year of entry
11. Other evidence or histroy of severe illness
12. Thyroid disease poorly controlled
13. Alphafetoprotein (AFP) >100 ng/ml

Recruitment start date

01/04/2004

Recruitment end date

01/10/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Medizinische Hochschule Hannover
Hannover
30625
Germany

Sponsor information

Organisation

Hannover Medical School (MHH) (Germany)

Sponsor details

Kompetenznetz Hepatitis (Hep-Net e.V.)
Department for Gastroenterology
Hepatology and Endocrinology
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Sponsor type

University/education

Website

http://www.kompetenznetz-hepatitis.de

Funders

Funder type

University/education

Funder name

Network of competence for hepatitis (Kompetenznetz Hepatitis [Hep-Net e.V.]), c/o Hannover Medical School (Medizinische Hochschule Hannover [MHH]) (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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21268724

Publication citations

  1. Results

    Wedemeyer H, Yurdaydìn C, Dalekos GN, Erhardt A, Çakaloğlu Y, Değertekin H, Gürel S, Zeuzem S, Zachou K, Bozkaya H, Koch A, Bock T, Dienes HP, Manns MP, , Peginterferon plus adefovir versus either drug alone for hepatitis delta., N. Engl. J. Med., 2011, 364, 4, 322-331, doi: 10.1056/NEJMoa0912696.

Additional files

Editorial Notes