Phase 1 Lupus Trial, Recruiting NCT04976465 Sponsor: Qilu Hospital of Shandong University Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT04976465
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:

  • You have been diagnosed with systemic lupus erythematosus (SLE), confirmed using standard medical criteria
  • You are pregnant and between 20 and 45 years old
  • You are willing to take part in the study, follow the treatment plan, attend follow-up appointments, and sign a consent form

Who may not be able to join:

  • You have had a previous miscarriage that was found to be caused by a known reason, such as chromosomal problems in you, your partner, or the embryo (confirm with trial site)
  • You have a known hormone or gland condition such as polycystic ovary syndrome, problems with your ovaries, high prolactin levels, thyroid disease, or diabetes-related hormonal issues
  • You have a known physical problem with your uterus, cervix, or vagina, such as an abnormally shaped uterus, scarring inside the uterus, large fibroids (over 5 cm), or a vaginal infection
  • You have a serious known condition affecting your heart, liver, kidneys, blood, or hormone system
  • You currently have an active infection, including hepatitis B, hepatitis C, HPV, HIV, chickenpox/shingles, syphilis, or tuberculosis
  • You are allergic to any of the following medications: prednisone, hydroxychloroquine, low molecular weight heparin, or aspirin
  • You have a history of stomach ulcers or bleeding in the upper digestive tract
  • You have a history of cancer
  • You have a history of epilepsy or a psychiatric condition
  • You are unwilling or unable to attend follow-up appointments during pregnancy and after giving birth

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 28 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: Xiaoyun Yang, Dr., Qilu Hospital of Shandong University

Phone: 0086-0531-82169654

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
Sponsor
Qilu Hospital of Shandong University
Registry
ClinicalTrials.gov
Start date
1 January 2018
Est. completion
30 July 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Live birth rate

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: 28 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