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A multicenter randomised study comparing the efficacy of adefovir dipivoxil versus pegylated interferon alpha-2a plus placebo versus adefovir dipivoxil plus peglyated interferon alpha-2a for the treatment of chronic delta hepatitis
ISRCTN ISRCTN83587695
DOI 10.1186/ISRCTN83587695
ClinicalTrials.gov identifier
EudraCT number
Public title A multicenter randomised study comparing the efficacy of adefovir dipivoxil versus pegylated interferon alpha-2a plus placebo versus adefovir dipivoxil plus peglyated interferon alpha-2a for the treatment of chronic delta hepatitis
Scientific title
Acronym Delta Study
Serial number at source 3388
Study hypothesis Peg-interferon alpha-2a or adefovir lead to sustained virological response in 20-40% of the cases in chronic delta hepatitis.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Adults with chronic delta hepatitis
Participants - 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
Participants - 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
Anticipated start date 01/04/2004
Anticipated end date 01/10/2004
Status of trial Completed
Patient information material
Target number of participants 69
Interventions 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
Primary outcome measure(s) Response rate of normal ALT and HDV RNA negativity at the end of treatment (ETR)
Secondary outcome measure(s) 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)
Sources of funding Network of competence for hepatitis (Kompetenznetz Hepatitis [Hep-Net e.V.]), c/o Hannover Medical School (Medizinische Hochschule Hannover [MHH]) (Germany)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21268724
Contact name Prof  Michael P  Manns
  Address Medizinische Hochschule Hannover
Department for Gastroenterology, Hepatology and Endocrinology
Carl-Neuberg-Str. 1
  City/town Hannover
  Zip/Postcode 30625
  Country Germany
  Tel +49 5115323306
  Fax +49 5115324896
  Email manns.michael@mh-hannover.de
Sponsor Hannover Medical School (MHH) (Germany)
  Address Kompetenznetz Hepatitis (Hep-Net e.V.)
Department for Gastroenterology, Hepatology and Endocrinology
Carl-Neuberg-Str. 1
  City/town Hannover
  Zip/Postcode 30625
  Country Germany
  Sponsor website: http://www.kompetenznetz-hepatitis.de
Date applied 03/08/2005
Last edited 02/02/2011
Date ISRCTN assigned 09/09/2005
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