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Liver disease drug trial pulled before it even started

NCT ID NCT02900183

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to test an experimental drug called ARC-AAT in people with Alpha-1 Antitrypsin Deficiency (AATD), a genetic condition that can cause liver and lung damage. The drug was designed to reduce harmful protein buildup in the liver. However, the trial was withdrawn before any participants were enrolled, so no data on safety or effectiveness were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARC-AAT (an RNA interference drug)
What this could lead to
If it had worked, this could have pointed toward a treatment to reduce harmful protein buildup in the liver for people with Alpha-1 Antitrypsin Deficiency.
What could go wrong
This trial was withdrawn before enrolling anyone, so no results are available. The approach was still early (Phase 2) and required invasive liver biopsies, which carry risks.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Oct 2016

An estimate. Start dates often move.

Finished

Nov 2016

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.

Ages

18 to 75 years

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: * Male or non-nursing female patients 18-75 years of age, inclusive, at the time of Screening * Previous diagnosis of PiZZ genotype Alpha-1 Antitrypsin Deficiency (AATD) * Non-smoker (not a daily cigarette smoker) for at least three years with current non-smoking status confirmed by urine cotinine at screening. * Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the last dose of ARC-AAT Injection * Suitable venous access for blood sampling Exclusion Criteria: * Known diagnosis of hepatic fibrosis from a cause other than AATD * History of poorly controlled autoimmune disease, or any history of autoimmune hepatitis * Human immunodeficiency virus (HIV) infection * Seropositive for Hepatitis B virus (HBV) or Hepatitis C virus (HCV) * Uncontrolled hypertension * History of cardiac rhythm disturbances * Symptomatic heart failure, unstable angina, myocardial infarction, severe cardiovascular disease, transient ischemic attack (TIA) or cerebrovascular accident (CVA) within 6 months prior to study entry * History of malignancy within the last 2 years except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer * History of major surgery within 1 month of Screening * Regular use of alcohol within one month prior to the Screening visit * Use of illicit drugs (such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to Screening or positive urine drug screen at Screening * Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving a therapeutic intervention * Any clinically significant history/presence of an uncontrolled systemic disease * Blood donation (≥500 mL) within 7 days prior to study treatment administration

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site 1

    Toronto, Ontario, M5T3A9, Canada

  • Research Site 2

    Dublin, Ireland

  • Research Site 3

    Pavia, 27100, Italy

  • Research Site 4

    Malmö, SE-205 02, Sweden

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