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Clinical Trials/EUCTR2010-024586-45-DE
EUCTR2010-024586-45-DEActive, not recruitingNot Applicable

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB) - Not applicable

Gilead Sciences Inc.0 sites720 target enrollmentStarted: August 11, 2011Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
720
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline.
  • •Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose = 24 weeks prior to screening are also eligible.
  • •HBV DNA = 20,000 IU/ml for HBeAg+ subjects and HBV DNA = 2,000 IU/ml for HBeAg- subjects
  • •ALT > 54 U/L and = 400 U/L for men and > 36 U/L and = 300 U/L for women
  • •Creatinine clearance rate greater than or equal to 80 mL/min
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 706
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

  • •Known bridging fibrosis or cirrhosis and/or decompensated liver disease
  • •Decompensated liver disease
  • •Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
  • •Evidence of hepatocellular carcinoma
  • •Histroy of significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
  • •History of severe depression or severe psychiatric disease
  • •Thyroid dysfunction
  • •Co-infection with HIV, HCV or HDV
  • •Ongoing therapy with any of the following:
  • •Nephrotoxic agents
  • •— Parenteral aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin)
  • •— Cidofovir
  • •— Cisplatin
  • •— Foscarnet
  • •— IV amphotericin B
  • •— IV pentamidine
  • •— Oral or IV ganciclovir
  • •— Cyclosporine
  • •— Tacrolimus
  • •— IV vancomycin
  • •— Chronic daily non-steroidal anti-inflammatory drug therapy
  • •Hepatotoxic agents such as anabolic steroids, isoniazid, itraconazole, ketoconazole, rifabutin, rifampin and other agents with significant hepatotoxic potential
  • •Competitors of renal excretion (e.g., probenecid)
  • •Systemic chemotherapeutic agents
  • •Systemic corticosteroids
  • •Interleukin-2 (IL-2) and other immunomodulating agents
  • •Investigational agents (except with the expressed approval of the Sponsor)
  • •Administration of any of the above mentioned medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.

Investigators

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