Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON32978
NL-OMON32978
Completed
Not Applicable

A randomized open-label prospective trial for comparing combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Adefovir dipivoxil (Hepsera®) and combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Tenofovir disoproxil fumarate (Viread®) versus no treatment in HBeAg negative chronic hepatitis B patients with low viral load* - HBsAg loss during treatment with Peg-IFN combined with ADV or TDF

Academisch Medisch Centrum0 sites150 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionschronic hepatitis Bviral hepatitis1001965410047438

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
chronic hepatitis B
Sponsor
Academisch Medisch Centrum
Enrollment
150
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Male and female patients \> 18 and \<\= 70 years of age
  • •2\.Positive HBsAg for more than 6 months.
  • •3\.Negative for HBeAg for more than 6 months.
  • •4\.Patients with chronic hepatitis B who are either naive to antiviral treatment, or have received either interferon (IFN) or nucleoside/nucleotide analogues in the past but are still positive for HBsAg.
  • •5\.Serum ALT\< 5 \* ULN as determined by two values taken \>14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained during the screening period.
  • •6\.Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24\-hour period prior to the first dose of test drug

Exclusion Criteria

  • •1\.Patients co\-infected with HCV, HIV or who have decompensated liver disease, hepato\-cellular carcinoma, significant cardiac disease, significant renal disease, seizure disorders or severe retinopathy.
  • •2\.Patients who have received nucleos(t)ide analogues for their chronic hepatitis B within 6 weeks before enrollment or Peg\-IFN within 3 months before enrollment.
  • •3\.Patients must not have received any other systemic anti\-viral, anti\-neoplastic or immuno\-modulatory treatment (including supraphysiologic doses of steroids or radiation) \<3 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
  • •4\.Positive test at screening for anti\-HAV IgM, anti\-HIV, HCV RNA. (Patients that have cleared the hepatitis C virus can be included in the study)
  • •5\.Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had a limited (\<7 day) course of acyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
  • •6\.Evidence of decompensated liver disease (Child Pugh B\-C)
  • •7\.Serum total bilirubin \> twice the upper limit of normal at screening
  • •8\.History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease.
  • •9\.History or other evidence of a medical condition associated with chronic liver disease other than HBV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver diseases including Wilson\*s disease and alfa1\-antitrypsin deficiency, alcoholic liver disease, toxin exposures, thalassemia).
  • •10\.Women with ongoing pregnancy or who are breast feeding.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A prospective randomised, open-labelled, trial comparing sirolimus- containing versus mTor-Inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. - SiLVERProphylaxis against liver transplant rejection in patients undergoing liver transplantation for hepatocellular carcinoma (HCC)MedDRA version: 8.1Level: LLTClassification code 10050434
EUCTR2005-005362-36-BERegensburg University Medical Center482
Not yet recruiting
Phase 3
A prospective, randomised, open label trial on the effect of metformin on in-vitro fertilisation outcome in women with polycystic ovary syndromeInfertilityPolycystic ovary syndromeReproductive Health and Childbirth - Fertility including in vitro fertilisationMetabolic and Endocrine - Other metabolic disorders
ACTRN12609000510246Fertility Society of Australia124
Active, not recruiting
Phase 1
A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. - This trial will be referred to as ARTEMIS.
EUCTR2005-002486-36-GBTibotec Pharmaceuticals Limited
Active, not recruiting
Not Applicable
A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. - This trial will be referred to as ARTEMIS.
EUCTR2005-002486-36-BETibotec Pharmaceuticals Limited660
Active, not recruiting
Not Applicable
A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. - This trial will be referred to as ARTEMIS.
EUCTR2005-002486-36-DETibotec Pharmaceuticals Limited660