Clinical Studies

Breast Care
Cardiology
Colon Cancer
Dermatology
Diabetes
Gastrointestinal
HIV/AIDS
Mental Health
Neurology
NeuroOphthalmology
Obesity/Weight Management
Women's Health
Other


Special Features
Advances/Research

 

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 α-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B 

Principal Investigator:   Albert Min, MD
Time frame of study:   Closed to enrollment, subjects still active
Location of Study:   Mount Sinai Beth Israel
Contact name, number and email  

Duyang Kim at 212-844-6446 or dukim@chpnet.org


Summary:
The purpose of the study is to evaluate how effective a 48 week course of an investigational drug, [Tenofovir Disoproxil Fumarate (TDF)], is in combination with Peg-IFN. This will be compared to TDF alone or Peg-IFN alone.  This will be determined by the Presence of HBsAg after completion of treatment. Eligible subjects will be randomized to one of the 4 treatment arms (1:1:1:1, or a 25% chance of each of the four arms): TDF and Peg-IFN together for 48 weeks; TDF and Peg-IFN together for 16 weeks followed by TDF alone for another 32 weeks (total 48 weeks); TDF alone through 120 weeks; and Peg-IFN alone for 48 weeks. Patients who are receiving a total of 48 weeks of therapy will come in for follow-up visits through 120 weeks. All research procedures, including drug, are covered by the sponsor.


Eligibility Participants:

  • At least 18 years of age
  • Are Non-Cirrhotic
  • Are diagnosed with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B

For additional information, or to participate, please contact Duyang Kim at 212-844-6446 or dukim@chpnet.org