ISRCTN83587695
Completed
Not Applicable
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
Hannover Medical School (MHH) (Germany)0 sites69 target enrollmentSeptember 9, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adults with chronic delta hepatitis
- Sponsor
- Hannover Medical School (MHH) (Germany)
- Enrollment
- 69
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A multicenter randomised study comparing the efficacy of pegylated interferon-alfa-2a plus placebo vs. pegylated interfeorn-alfa-2a plus tenofovir for the treatment of chronic delta hepatitis- The Hep-Net International Delta hepatits Interventional Trial II (HIDIT-II) - HIDIT-IITo compare the virological efficacy (HDV-RNA) and safety of 96 weeks of therapy with pegylated interferon-alfa-2a plus tenovofir to 96 weeks of therapy with pegylated interferon-alfa-2a plus placebo for the treatment with chronic delta hepatits virus.MedDRA version: 9.1Level: LLTClassification code 10047455Term: Viral hepatitis B without mention of hepatic coma, with hepatitis deltaEUCTR2008-005560-13-GRMedizinische Hochschule Hannover70
Active, not recruiting
Phase 1
Treatment of delta hepatitis with pegylated interferon-alfa-2a and tenofovir or placeboTo compare the virological efficacy (HDV-RNA) and safety of 96 weeks of therapy with pegylated interferon-alfa-2a plus tenovofir to 96 weeks of therapy with pegylated interferon-alfa-2a plus placebo for the treatment with chronic delta hepatits virus.MedDRA version: 15.1Level: LLTClassification code 10047455Term: Viral hepatitis B without mention of hepatic coma, with hepatitis deltaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2008-005560-13-DEMedizinische Hochschule Hannover70
Active, not recruiting
Not Applicable
A multicentre randomised trial comparing the effects of 2% chlorhexidine gluconate in 70% isopropyl alcohol as a skin, exit site and catheter hub cleansing agent versus other forms of chlorhexidine gluconate which are in routine use, on central venous catheter-related infections in haemodialysis patientsPrevention of central venous catheter-related infections in haemodialysis patients.This trial will evaluate the effectiveness of 2% chlorhexidine gluconate in 70%isopropyl alcohol as a skin, exit site and catheter hub cleansing agent in the reduction of CVC-related infections in haemodialysis patients, in comparison to the other forms of chlorhexidine gluconate that are in routine use in dialysis centres in Ireland.EUCTR2010-019984-12-IEAdelaide & Meath Hospital, incorporating The National Children's Hospital180
Recruiting
Not Applicable
A Randomized Multicenter Study Comparing the Effectiveness of Hemi- Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint DiseaseM19.91M15M15-M19PolyarthrosisArthrosisDRKS00003072AO Foundation94
Completed
Not Applicable
Efficacy of transfusions with platelets stored in platelet additive solution II versus plasmaPlatelet transfusionSigns and SymptomsTransfusionISRCTN52543592eyenburg Hospital (The Netherlands) - Department of Hematology195