🏛️ Verified NIH Record • Updated 2026-08-11

Safety of HRX215 in Patients After Minor and Major Liver Resection (NCT06638502)

Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: HepaRegeniX GmbH

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases. The objectives are: 1. to learn about the safety and tolerability of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215. 3. to learn about clinical activity of HRX215 Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.

Who can join: Review the eligibility criteria below.

Location: Johns Hopkins Hospital — Baltimore, Maryland

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (12 Sites)

  • Johns Hopkins Hospital — Baltimore, Maryland
  • Mayo Clinic — Rochester, Minnesota
  • Cleveland Clinic — Cleveland, Ohio
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez — Lille,
  • Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB) — Villejuif,
  • Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie — Tübingen,
  • Rabin Medical Center — Petah Tikva,
  • Sheba Medical Center — Ramat Gan,
  • Tel-Aviv Sourasky MC — Tel Aviv,
  • Hospital Universitario La Paz — Madrid,
  • South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro — Madrid,
  • Consorci Hospital General Universitari de València — Valencia,

📞 Contact the Study Coordinator

Phone: +49 7071 7912809

Email: info@heparegenix.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Liver Resection clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗