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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21268724
Publication citations
-
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.