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New combo aims to tame autoimmune anemia without Long-Term steroids

NCT ID NCT07518277

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding sirolimus to standard steroid treatment helps people with newly diagnosed mild autoimmune hemolytic anemia (AIHA) achieve lasting remission. About 216 adults will be randomly assigned to get either steroids alone or steroids plus sirolimus for 6 months, then followed for 2 years. The main goal is to see if more people in the combo group can stop steroids and stay in remission at 12 months.

What this could mean

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

Active substance
sirolimus combined with glucocorticoids (steroids)
What this could lead to
If it works, this could offer a way to treat AIHA with fewer steroids and a higher chance of staying in remission without ongoing medication.
What could go wrong
This is an early-stage trial with no phase assigned, so results are uncertain. Sirolimus can cause side effects like infections or metabolic issues, and the benefit over steroids alone may be small.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 216 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Age ≥18 years old, gender not limited; 2. Diagnosed as newly diagnosed wAIHA and requiring systemic immunosuppressive therapy (those with short-term hormone exposure of ≤2 weeks before enrollment can be included) 3. After a comprehensive rheumatology and immunology assessment, there is no evidence of clinical organ involvement in SLE or other connective tissue diseases (only serological abnormalities can be included). 4. Positive Coombs test (IgG type, IgG+C3d type, or only C3d type with a condensed agglutinin titer of 1:64); 5. Active hemolytic anemia, hemoglobin (HGB) ≤ 100 g/L; 6. Liver and kidney function: Alanine aminotransferase (ALT) \< 3 times the upper limit of the normal value (ULN), isolated elevation of aspartate aminotransferase (AST) (normal ALT) is acceptable; Serum creatinine ≤2×ULN; 7. Eastern Cooperative Oncology Group (ECOG) Performance status score ≤2 points; 8. Those with a history of malignant tumors must meet the following conditions: Radical treatment has been achieved; The disease-free survival period complies with the protocol provisions (such as ≥1 year for basal cell carcinoma, ≥5 years for early solid tumors, ≥5 years for curable lymphoma, etc.); There is currently no evidence of recurrence. Those who do not meet the above conditions (such as CLL, advanced solid tumors, and active tumors) are not included. 9. Voluntarily sign a written informed consent form. Exclusion Criteria: 1. Pregnant or lactating patients; 2. Clinically confirmed SLE or other definite connective tissue diseases; 3. Secondary AIHA secondary to lymphoproliferative diseases, other hematological malignancies, solid tumors, infections, and drugs; 4. Cold-resistant type or hybrid type AIHA; 5. Received before group enrollment: Other immunosuppressants (such as rituximab, cyclosporine, etc., regardless of the duration); Glucocorticoid treatment for more than 2 weeks; 6. Severe cardiac insufficiency (NYHA grade III/IV, or LVEF \< 40%); 7. Currently active malignant tumors, or previous tumors that do not meet the requirements of Article 8 of the inclusion criteria; 8. Chronic active infections (active tuberculosis, active hepatitis B/C, etc.); 9. Severe immunodeficiency diseases, HIV infection (CD4⁺ \< 200/μL), currently using other potent immunosuppressants, and using targeted biological agents within the last 3 months; 10. Have a history of severe allergy to sirolimus, glucocorticoids or related excipients; 11. Other circumstances where the researcher deems it inappropriate to participate.

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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.

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Peking union medical college hospital

    Beijing, Shuangfuyuan, NO I., 100730, China

More trials for these conditions

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