Phase 2 Hepatitis C Trial, Recruiting NCT03383419 Sponsor: Baylor Research Institute Condition: Hepatitis C
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Phase 2 Hepatitis C Trial, Recruiting

NCT03383419
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to sign a written consent form agreeing to take part
  • You are 18 years old or older
  • You are on the waiting list for a heart transplant (heart only, not combined with another organ)
  • You have tested negative for Hepatitis C (HCV), OR if you previously tested positive, you must have had at least 2 blood tests showing the virus is no longer detectable, your last Hepatitis C treatment must have been at least 12 weeks ago, and both negative results must have been taken at least 12 weeks after finishing that treatment

Who may not be able to join:

  • You are listed for a transplant involving more than one organ at the same time
  • You have or have had an active Hepatitis C virus in your blood, unless you have been confirmed fully cured
  • You have tested positive for Hepatitis B (unless a doctor has confirmed this was caused only by a recent vaccination)
  • You have been diagnosed with cirrhosis (serious liver scarring), confirmed by a liver biopsy
  • You have high blood pressure in the vessels around your liver, or have been found to have swollen veins in your food pipe (esophageal varices)
  • You have significantly raised liver enzyme levels (ALT and AST) in your blood, unless a doctor has confirmed these are coming from your heart or muscles rather than your liver (confirm with trial site)
  • You have had a solid organ transplant (such as a kidney, liver, or lung) in the past
  • You are currently pregnant
  • You have a history of HIV infection
  • You have severe kidney disease and are currently on dialysis, or your kidney function test results have been very low on your last two checks before a donor organ is offered
  • You have had, or are planned to have, immune desensitization therapy (a treatment to reduce antibodies that could cause organ rejection) (confirm with trial site)
  • Your blood tests show that your immune system would likely attack a donor organ (known as a positive cross-match) (confirm with trial site)
  • You are not willing to tell your sexual partner(s) that you are taking part in this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Shelley A Hall, MD, FACC, FHFSA, Baylor University Medical Center/ Baylor Scott & White Research Institute

Phone: 214-820-1675

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Baylor Research Institute
Registry
ClinicalTrials.gov
Start date
20 March 2018
Est. completion
30 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Sustained virologic response after 12 weeks of treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov