Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Researchers dig into records to see if new IV platform is safe

NCT ID NCT07609069

Knowledge-focused Sponsor: PICO IV, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks back at the medical records of 625 people who received an experimental IV drug delivery system. The goal is to see what side effects happened during or after the infusion and whether anyone had to stop treatment early because of them. No new treatments or visits are involved—just a review of past data.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 625 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of a retrospective cohort of subjects who received (IV) infusions of the Sponsor's proprietary sub-nanometer micellar delivery platform (evaluating a legacy heterogeneous payload and the highly purified PIV-850 synthetic-equivalent dual-NCE matrix) within private medical clinics, specialty infusion centers, and outpatient practice settings across the United States. The sample is drawn from a diverse clinical population evaluated between June 1, 2025, and April 15, 2026. To ensure high-fidelity safety data and eliminate selection bias, the population is derived via a mandatory 100% consecutive sampling algorithm at each activated site. This cohort represents subjects receiving investigational micellar infusions for a range of legacy clinical observations in routine medical practice, utilizing exclusively single-use sterile vials to ensure alignment with pharmaceutical-grade Chemistry, Manufacturing, and Controls (CMC) sterile fill-finish standards.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must have received at least one intravenous (IV) investigational exposure of the PICO IV 850-picometer micellar platform (evaluating either a legacy heterogeneous payload or the PIV-850 synthetic-equivalent dual-NCE matrix) between June 1, 2025, and April 15, 2026. * The investigational product administered must have been drawn exclusively from a Single-Use Sterile Vial. * The participant record must have been identified via a 100% consecutive sampling algorithm (15 to 25 patients per site) at the clinical site to eliminate selection bias. * Electronic Medical Record (EMR) or clinic infusion logs must contain complete data regarding dosing, administration route (IV Push vs. IV Drip), and post-infusion safety observations. Exclusion Criteria: * Participants whose exposures were drawn from legacy multi-use vials. * Participants with exposures occurring outside the specific date window of June 1, 2025 - April 15, 2026. * Participants with incomplete clinical records where Infusion-Emergent Adverse Events (IEAEs) or safety outcomes were not documented. * Participants whose records were not identified chronologically backward from April 15, 2026.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Drug-related side effects and adverse reactions are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Drug-Related Side Effects and Adverse Reactions

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug-related side effects and adverse reactions Infusion reactions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • PICO IV Central Data Coordinating Center

    Sacramento, California, 95811, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.