Surakit Pungpapong, M.D.

Closed for Enrollment

• A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection Jacksonville, Fla.

  This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

• A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant Jacksonville, Fla.

  The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

• A Randomized, Double-blind, Placebo-controlled, Phase 2a Study with Open-label Extension to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients with Autoimmune Hepatitis (PORTOLA) Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the safety and effectiveness of zetomipzomib in addition to standard-of-care in patients with autoimmune hepatitis (AIH) who have failed standard-of-care treatment, had an incomplete biochemical response to ≥3 months of standard-ofcare treatment, or had a disease flare after standard-of-care treatment.

• A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) Jacksonville, Fla.

  This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).

• HCV-TARGET: Hepatitis C Therapeutic Registry and Research Network - A Longitudinal, Observational Study Jacksonville, Fla.

  The primary purpose of the study is to establish a long-term nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C  at academic and community practices.

• Phase I Trial of a Therapeutic DNA Vaccine for Chronic Hepatitis C Virus (HCV) Infection Jacksonville, Fla., Rochester, Minn.

  The purpose of this study is to determine whether INO-8000 alone or in combination with INO-9012 (IL-12) is safe and induces a Hepatitis C virus-specific immune response.

• Pilot Study for the Use of Shortened Preemptive therapy with Glecaprevir/pibrentasvir (G/P) and ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Both drugs are FDA-approved. Mavyret™ is currently used commercially to treat Hepatitis C and Zetia® is used commercially to treat high cholesterol.