Phase 1 Hepatitis C Trial, Recruiting NCT06062966 Sponsor: Virginia Commonwealth University Condition: Hepatitis C
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Phase 1 Hepatitis C Trial, Recruiting

NCT06062966
Recruiting Phase 1

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:

  • People whose main reason for the clinic visit is advanced (stage D) heart failure, and who have been on a steady, unchanged dose of a heart-support drip medication (dobutamine or milrinone) for at least the past 28 days
  • People who have had imaging (such as an echocardiogram) within the past 12 months showing that their heart's pumping strength is below 50%
  • People whose inotrope (heart-support drip) dose has been stable and who have not been hospitalised in the past month
  • People aged 21 or older who are willing and able to sign a written consent form
  • People who are willing and able to follow the study plan, including self-administering the study treatment and taking part in an exercise protocol
  • People whose blood test at screening shows a C-reactive protein (an inflammation marker) level above 2 mg/L

Who may not be able to join:

  • People who have other significant medical conditions — such as a recent heart attack, poorly controlled blood pressure, certain heart rhythm problems, serious lung disease, or nerve/muscle disorders affecting breathing — that could interfere with the study
  • People who have had, or are planning to have, a cardiac resynchronisation therapy (CRT) device procedure or heart valve surgery within the past 3 months or upcoming
  • People who have had, or are planning to have, a mechanical heart pump (left ventricular assist device) fitted or a heart transplant within the next 3 months
  • People who have used immune-suppressing or strong anti-inflammatory medicines (including certain steroid tablets) in the past 14 days (confirm with trial site for exact medicines included)
  • People who have a long-term inflammatory condition such as rheumatoid arthritis or lupus
  • People who have an active infection of any kind, or a chronic or recurring infectious disease such as hepatitis B, hepatitis C (unless hepatitis C is fully suppressed with no detectable virus), or HIV/AIDS
  • People who have had, or currently have, a cancer that is being treated with targeted therapy within the past 5 years — though people with certain very early-stage or localised skin cancers may still be considered (confirm with trial site)
  • People with very advanced (stage 5) kidney disease or who are on dialysis or another kidney-replacement treatment
  • People with a low white blood cell count (neutropenia), below specific thresholds depending on ethnic background
  • People who are pregnant or breastfeeding
  • People who experience chest pain, high blood pressure, heart rhythm problems, abnormal ECG readings, or other limitations during the baseline walking test that affect the result
  • People who have a known allergy or sensitivity to the study drug anakinra, or to products derived from E. coli bacteria

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 27 July 2026
Phase 1: approximately ~10% 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: Azita Talasaz, Virginia Coomonwealth University

Phone: 8048284583

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 1
Registry
ClinicalTrials.gov
Start date
5 February 2024
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percent reduction in high-sensitive C-Reactive Protein (hsCRP, a biomarker for IL-1 activity)

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: 27 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