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

Completed

Conditions: Adults with chronic delta hepatitis
Infections and Infestations

Registration Number: ISRCTN83587695

Lead Sponsor: Hannover Medical School (MHH) (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 69

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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