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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83587695

Enrollment

Registered

2005-09-09

Start date

2004-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adults with chronic delta hepatitis Infections and Infestations Adults with chronic delta hepatitis

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

biopsy at the end of treatment

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026